A Phase 3 interventional study of bevacizumab [Avastin] and Chemotherapy in Breast Cancer, sponsored by Hoffmann-La Roche. Completed at 132 sites in 13 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-02-11.
Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment
This randomized, open-label, parallel-group study will assess the efficacy and s afety of Avastin (bevacizumab) in combination with chemotherapy versus chemother apy alone as second- and third-line therapy in patients with locally recurrent o r metastatic breast cancer progressing after first-line therapy with Avastin and chemotherapy. Patients will be randomized to receive either Avastin (15 mg/kg e very 3 weeks or 10 mg/kg every 2 weeks intravenously) plus standard chemotherapy or chemotherapy alone. Anticipated time on study treatment is until third-line disease progression or unacceptable toxicity occurs.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 494 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Chemotherapy
Drug: bevacizumab [Avastin] · Drug: Chemotherapy
10 mg/ kg iv every 2 weeks or 15 mg/kg iv every 3 weeks
Standard chemotherapy (doublets not allowed)
Percentage of Participants With Second-Line Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1)
Second-line PFS was defined as the time from randomization to progressive disease (PD) or death due to any cause during their second-line of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For target lesions (TLs), PD was defined at least a 20 percent (%) increase in the sum of the largest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For non-target lesions (NTLs), PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
Time frame: Baseline (less than or equal to [≤] 28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years
Second-Line PFS
The median time, in months, from randomization to second-line PFS event. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
Time frame: Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years
Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 6
Second-line PFS was defined as the time from randomization to PD or death due to any cause during their second-line of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
Time frame: Month 6
Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 12
Second-line PFS was defined as the time from randomization to PD or death due to any cause during their second-line of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without secondline PD or death were censored at the date of last tumor assessment where non-progression was documented.
Time frame: Month 12
Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 18
Second-line PFS was defined as the time from randomization to PD or death due to any cause during their secondline of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
Time frame: Month 18
Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 24
Second-line PFS was defined as the time from randomization to PD or death due to any cause during their second-line of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
Time frame: Month 24
Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013)
The median time, in months, from randomization to second-line PFS event according to the following baseline risk factors: hormone receptor negative, HER2 negative (triple negative), hormone receptor positive/HER-2 negative (HR-pos/HER-neg), first-line PFS less than (\<) 6 months, first-line PFS greater than or equal to (≥) 6 months, taxane chemotherapy (chemo), non-taxane chemo, vinorelbine chemo, LDH ≤ 1.5 upper limit of normal (ULN), LDH greater than (\>) 1.5 ULN, \< 65 years of age, ≥ 65 years of age, \< 70 years of age, ≥ 70 years of age, \< 3 metastatic organ sites, ≥ 3 metastatic organ sites, bevacizumab-free (B-free) interval ≤ 6 weeks, B-free \> 6 weeks, disease-free (D-free) interval ≤ 24 months, D-free \> 24 months, D-free ≤ 12 months, and D-free \> 12 months. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented. PD: defined in Outcome measure 1. The 95% CI was estimated using Kaplan-Meier methodology.
Time frame: Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years
Percentage of Participants With a Second-Line Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) According to RECIST v1.1 (Data Cutoff 20 December 2013)
BOR was defined as a confirmed CR or PR during second-line treatment. For TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. The 95% Cl was determined using the Pearson-Clopper method.
Time frame: Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years
Percentage of Participants With a Second-Line CR, PR, Stable Disease, and PD According to RECIST v1.1 (Data Cutoff 20 December 2013)
For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; stable disease was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits; and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. The 95% CI was determined using the Pearson-Clopper method.
Time frame: Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years
Duration of Second-Line Objective Response (Data Cutoff 20 December 2013)
The median time, in months, from the date of the first second-line documentation of CR or PR according to RECIST v1.1 to the date of the first second-line documentation of PD or death due to any cause. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels, and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants with CR or PR who had experienced neither disease progression nor died were censored at the date of the last available tumor assessment when the participant was known to be progression free.
Time frame: Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years
Percentage of Participants With a Second-Line Documented CR or PR According to RECIST v1.1 Estimated to be Alive and Free of Disease Progression at Months 3, 6, and 9 (Data Cutoff 20 December 2013)
Duration of objective response was defined as the median time, in months, from the date of the first second-line documentation of CR or PR to the date of the first second-line documentation of PD or death due to any cause. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels, and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants with CR or PR who had experienced neither disease progression nor died were censored at the date of the last available tumor assessment when the participant was known to be progression free.
Time frame: Months 3, 6, and 9
Percentage of Participants With Third-Line PFS According to RECIST v1.1
Third-line PFS was defined as the time from the date of first dose of third-line bevacizumab and/or chemotherapy to the date of third-line PD or death due to any cause. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
Time frame: First dose of third-line treatment until PD or death due to any cause (assessed every 8-9 weeks, over a period of approximately 14 months)
Third-Line PFS
The median time, in months, from the first dose of third-line bevacizumab and/or chemotherapy to third-line PD or death due to any cause. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
Time frame: First dose of third-line treatment until PD or death due to any cause (over a period of approximately 14 months)
Percentage of Participants With Second- and Third-Line PFS According to RECIST v1.1
Second- and third-line PFS was defined as the time from the date randomization to the date of third-line PD or death due to any cause. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
Time frame: Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 4 years
Second- and Third-Line PFS
The median time, in months, from randomization to second-line and third-line PFS event. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
Time frame: Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 4 years
Percentage of Participants With Second- and Third-Line Tumor Progression
Second- and third-line tumor progression was defined as occurrence of third-line PD according to RECIST v1.1 or death due to progression of disease. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death due to progression of disease were censored at the date of last tumor assessment where non-progression was documented.
Time frame: Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 4 years
Time to Second- and Third-Line Tumor Progression
The median time, in months, from randomization to second- and third-line tumor progression. Second- and third-line tumor progression was defined as third-line PD according to RECIST v1.1 or death due to progression of disease. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
Time frame: Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 4 years
Percentage of Participants Who Died
Percentage of participants who died due to any reason were reported.
Time frame: Baseline until death (up to approximately 4 years)
Overall Survival (OS)
OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Participants who had not died were censored at the date the patient was last known to be alive.
Time frame: Baseline until death (up to approximately 4 years)
Percentage of Participants Estimated to be Surviving at Months 6, 12, 18, and 24
OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause.
Time frame: Months 6, 12, 18, and 24
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
The EQ-5D is composed of 5 single-item measures where participants responded to questions assessing health status by responding with either "no problems", "some problems", or "extreme problems" in the following categories: mobility (M) ("no problems"="I have no problems in walking about" to "extreme problems"="I am confined to bed"), self-care (SC) ("no problems"="I have no problems with self-care" to "extreme problems"="I am unable to wash or dress myself"), usual activities (UA) ("no problems"="I have no problems performing my usual activities" to "extreme problems"="I am unable to perform my usual activities"), pain/discomfort (P/D) ("no problems"="I have no pain or discomfort" to "extreme problems"="I have extreme pain or discomfort"), and anxiety/depression (A/D) ("no problems"="I am not anxious or depressed" to "extreme problems"='I am extremely anxious or depressed").
Time frame: Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years)
Quality of Life Assessed As an Index Score Using the EQ-5D (Data Cutoff 20 December 2013)
The EQ-5D is composed of 5 single-item measures where participants responded to questions assessing health status by responding with either "no problems", "some problems", or "extreme problems" in the following categories: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Based on large population surveys, an algorithm was used to combine the responses to each of these 5 measures into 1 single EQ-5D index score ranging from -0.59 (extreme problems) to +1 (no problems).
Time frame: Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years)
Change From Baseline in EQ-5D Index Scores (Data Cutoff 20 December 2013)
The EQ-5D is composed of 5 single-item measures where participants responded to questions assessing health status by responding with either "no problems", "some problems", or "extreme problems" in the following categories: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Based on large population surveys, an algorithm was used to combine the responses to each of these 5 measures into 1 single EQ-5D index score ranging from -0.59 (extreme problems) to +1 (no problems) where a negative value indicated a worsening of perceived quality of life and a positive value indicated an improvement of perceived quality of life.
Time frame: Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years)
Quality of Life Assessed Using the EQ-5D Visual Analogue Scale (VAS) Scores (Data Cutoff 20 December 2013)
The participant was asked to rate their overall health on a 0-100 millimeter (mm) vertical scale, where the lowest endpoint=0 (labeled as worst imaginable health state) and the highest endpoint =100 (labeled as the best imaginable health state). The participant marked the line corresponding to their assessment and the distance from the bottom was measured in millimeters. A higher value indicated a better health state.
Time frame: Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years)
Change From Baseline in VAS Scores (Data Cutoff 20 December 2013)
The participant was asked to rate their overall health on a 0-100 mm vertical scale, where the lowest endpoint = 0 (labeled as worst imaginable health state) and the highest endpoint =100 (labeled as the best imaginable health state). The participant marked the line corresponding to their assessment and the distance from the bottom was measured in millimeters. A negative value indicated a worsening of perceived quality of life and a positive value indicated an improvement of perceived quality of life.
Time frame: Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years)
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
The Functional Assessment of Cancer Therapy-Breast (FACT-B) is composed of 5 multi-item sections where participants responded to questions assessing symptoms (scale: 0-4; 0="not at all" and 4="very much"), as follows: physical well-being (PWB) (7 items, total score 0-28), social/family well-being (SWB) (7 items, total score 0-28), emotional well-being (EWB) (6 items, total score 0-24), functional well-being (FWB) (7 items, total score 0-28); and breast cancer score based on the additional concerns section of FACT-B (10 items, total score 0-40). The FACT-B Trial Outcomes Index (TOI) score=sum of PWB, FWB, and breast cancer score subscale scores (total score 0-96). The Functional Assessment of Cancer Therapy-General (FACT-G) total score=sum of PWB, SWB, EWB, and FWB subscales scores (total score 0-108). The FACT-B total score=sum of PWB, SWB, EWB, FWB, and breast cancer score subscales scores (total score 0-148). In all cases a higher value indicated a better perceived quality of life.
Time frame: Baseline (≤28 days after randomization), every 8-9 weeks thereafter until second-line PD (up to approximately 3 years)
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
The FACT-B is composed of 5 multi-item sections where participants responded to questions assessing symptoms (scale: 0-4; 0="not at all" and 4="very much"), as follows: PWB (7 items, total score 0-28), SWB (7 items, total score 0-28), EWB (6 items, total score 0-24), FWB (7 items, total score 0-28); and breast cancer score based on the additional concerns section of FACT-B (10 items, total score 0-40). The FACT-B TOI score=sum of PWB, FWB, and breast cancer score subscale scores (total score 0-96). The FACT-G total score=sum of PWB, SWB, EWB, and FWB subscales scores (total score 0-108). The FACT-B total score=sum of PWB, SWB, EWB, FWB, and breast cancer score subscale scores (total score 0-148). In all cases a higher value indicated a better perceived quality of life.
Time frame: Baseline (≤28 days after randomization), every 8-9 weeks thereafter until second-line PD (up to approximately 3 years)
A total of 556 participants were screened and of these, 494 were randomized.
| Milestone | Chemotherapy (CT) Arm | Chemotherapy Plus Bevacizumab (CT+BV) Arm |
|---|---|---|
| Started | 247 | 247 |
| Completed | 45 | 54 |
| Not completed | 202 | 193 |
| Withdrew: Death | 141 | 148 |
| Withdrew: Withdrawal by subject | 32 | 20 |
| Withdrew: Physician decision | 11 | 3 |
| Withdrew: Protocol violation | 2 | 8 |
| Withdrew: Lost to follow-up | 9 | 6 |
| Withdrew: Adverse event | 5 | 4 |
| Withdrew: Other | 0 | 4 |
| Withdrew: Participant noncompliance | 2 | 0 |
Second-line PFS was defined as the time from randomization to progressive disease (PD) or death due to any cause during their second-line of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For target lesions (TLs), PD was defined at least a 20 percent (%) increase in the sum of the largest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For non-target lesions (NTLs), PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
| percentage of participants | CT Arm | CT+BV Arm |
|---|---|---|
| Percentage of Participants With Second-Line Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) | 88.7 | 93.9 |
The median time, in months, from randomization to second-line PFS event. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
| months | CT Arm | CT+BV Arm |
|---|---|---|
| Second-Line PFS | 4.2 (3.9 to 5.3) | 6.3 (5.5 to 7.6) |
The median time, in months, from randomization to second-line PFS event according to the following baseline risk factors: hormone receptor negative, HER2 negative (triple negative), hormone receptor positive/HER-2 negative (HR-pos/HER-neg), first-line PFS less than (\<) 6 months, first-line PFS greater than or equal to (≥) 6 months, taxane chemotherapy (chemo), non-taxane chemo, vinorelbine chemo, LDH ≤ 1.5 upper limit of normal (ULN), LDH greater than (\>) 1.5 ULN, \< 65 years of age, ≥ 65 years of age, \< 70 years of age, ≥ 70 years of age, \< 3 metastatic organ sites, ≥ 3 metastatic organ sites, bevacizumab-free (B-free) interval ≤ 6 weeks, B-free \> 6 weeks, disease-free (D-free) interval ≤ 24 months, D-free \> 24 months, D-free ≤ 12 months, and D-free \> 12 months. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented. PD: defined in Outcome measure 1. The 95% CI was estimated using Kaplan-Meier methodology.
| months | CT Arm | CT+BV Arm |
|---|---|---|
| HR-neg (n=60,56) | 2.1 (2.0 to 3.9) | 4.9 (3.4 to 6.1) |
| HR-pos/HER-neg (n=187,191) | 4.7 (4.2 to 6.2) | 6.7 (6.0 to 7.8) |
| PFS <6 months (n=69,68) | 3.9 (2.3 to 4.3) | 5.1 (4.1 to 6.9) |
| PFS ≥6 months (n=178,179) | 4.6 (3.9 to 6.1) | 6.4 (5.8 to 7.6) |
| Taxane chemo (n=32,32) | 3.2 (1.7 to 5.3) | 6.9 (4.9 to 9.8) |
| Non-taxane chemo (n=191,188) | 4.4 (3.9 to 5.8) | 6.0 (4.9 to 6.8) |
| Vinorelbine chemo (n=24,27) | 2.4 (1.8 to 4.3) | 6.5 (4.2 to 11.1) |
| LDH ≤ 1.5 ULN (n=207,210) | 4.4 (3.9 to 6.0) | 6.3 (5.5 to 7.6) |
| LDH > 1.5 ULN (n=40,37) | 2.1 (1.7 to 3.9) | 5.8 (2.5 to 7.3) |
| < 65 years of age (n=196,183) | 4.2 (3.9 to 4.7) | 6.1 (4.7 to 6.9) |
| ≥ 65 years of age (n=51,64) | 4.2 (2.2 to 7.8) | 6.7 (5.5 to 8.0) |
| < 70 years of age (n=226,219) | 4.2 (3.7 to 4.6) | 6.2 (5.3 to 7.3) |
| ≥ 70 years of age (n=21,28) | 7.8 (2.2 to 11.9) | 6.7 (4.1 to 11.2) |
| < 3 metastatic organ sites (n=158,167) | 4.2 (3.9 to 6.1) | 6.9 (6.0 to 8.2) |
| ≥ 3 metastatic organ sites (n=88,80) | 4.0 (2.1 to 4.9) | 4.7 (4.1 to 6.2) |
| B-free ≤ 6 weeks (n=165,149) | 4.2 (3.6 to 4.6) | 5.8 (4.4 to 6.6) |
| B-free > 6 weeks (n=81,98) | 4.4 (3.3 to 6.3) | 7.6 (6.0 to 9.5) |
| D-free ≤ 24 months (n=58,53) | 2.8 (2.0 to 3.9) | 5.8 (4.2 to 6.3) |
| D-free > 24 months (n=138,156) | 4.9 (4.0 to 6.1) | 6.5 (5.5 to 8.1) |
| D-free ≤ 12 months (n=24,18) | 2.1 (1.3 to 5.8) | 5.8 (3.9 to 9.7) |
| D-free > 12 months (n=172,191) | 4.3 (3.9 to 5.7) | 6.3 (5.3 to 7.6) |
BOR was defined as a confirmed CR or PR during second-line treatment. For TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. The 95% Cl was determined using the Pearson-Clopper method.
| percentage of participants | CT Arm | CT+BV Arm |
|---|---|---|
| Percentage of Participants With a Second-Line Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) According to RECIST v1.1 (Data Cutoff 20 December 2013) | 16.8 (11.7 to 22.9) | 20.9 (15.2 to 27.5) |
For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; stable disease was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits; and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. The 95% CI was determined using the Pearson-Clopper method.
| percentage of participants | CT Arm | CT+BV Arm |
|---|---|---|
| CR | 1.1 (0.1 to 3.9) | 0.5 (0.0 to 3.0) |
| PR | 15.7 (10.8 to 21.7) | 20.3 (14.7 to 26.9) |
| Stable disease | 33.5 (26.8 to 40.8) | 48.9 (41.4 to 56.4) |
| PD | 41.1 (33.9 to 48.5) | 24.2 (18.1 to 31.1) |
| Unable to assess | 8.6 (5.0 to 13.7) | 6.0 (3.1 to 10.6) |
The median time, in months, from the date of the first second-line documentation of CR or PR according to RECIST v1.1 to the date of the first second-line documentation of PD or death due to any cause. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels, and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants with CR or PR who had experienced neither disease progression nor died were censored at the date of the last available tumor assessment when the participant was known to be progression free.
| months | CT Arm | CT+BV Arm |
|---|---|---|
| Duration of Second-Line Objective Response (Data Cutoff 20 December 2013) | 10.6 (4.4 to 16.7) | 8.3 (6.1 to 10.3) |
Duration of objective response was defined as the median time, in months, from the date of the first second-line documentation of CR or PR to the date of the first second-line documentation of PD or death due to any cause. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels, and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants with CR or PR who had experienced neither disease progression nor died were censored at the date of the last available tumor assessment when the participant was known to be progression free.
| percentage of participants | CT Arm | CT+BV Arm |
|---|---|---|
| Month 3 | 96.7 (78.6 to 99.5) | 100.0 (NA to NA) |
| Month 6 | 69.0 (48.9 to 82.5) | 72.8 (55.3 to 84.4) |
| Month 9 | 60.9 (40.4 to 76.3) | 40.8 (24.6 to 56.3) |
Third-line PFS was defined as the time from the date of first dose of third-line bevacizumab and/or chemotherapy to the date of third-line PD or death due to any cause. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
| percentage of participants | CT Arm | CT+BV Arm |
|---|---|---|
| Percentage of Participants With Third-Line PFS According to RECIST v1.1 | 94.3 | 96.1 |
The median time, in months, from the first dose of third-line bevacizumab and/or chemotherapy to third-line PD or death due to any cause. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
| months | CT Arm | CT+BV Arm |
|---|---|---|
| Third-Line PFS | 2.9 (2.2 to 3.9) | 3.8 (2.4 to 5.1) |
Second- and third-line PFS was defined as the time from the date randomization to the date of third-line PD or death due to any cause. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
| percentage of participants | CT Arm | CT+BV Arm |
|---|---|---|
| Percentage of Participants With Second- and Third-Line PFS According to RECIST v1.1 | 71.7 | 83.4 |
The median time, in months, from randomization to second-line and third-line PFS event. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
| months | CT Arm | CT+BV Arm |
|---|---|---|
| Second- and Third-Line PFS | 10.7 (9.2 to 12.5) | 12.8 (10.7 to 14.5) |
Second- and third-line tumor progression was defined as occurrence of third-line PD according to RECIST v1.1 or death due to progression of disease. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death due to progression of disease were censored at the date of last tumor assessment where non-progression was documented.
| percentage of participants | CT Arm | CT+BV Arm |
|---|---|---|
| Percentage of Participants With Second- and Third-Line Tumor Progression | 67.2 | 75.3 |
The median time, in months, from randomization to second- and third-line tumor progression. Second- and third-line tumor progression was defined as third-line PD according to RECIST v1.1 or death due to progression of disease. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
| months | CT Arm | CT+BV Arm |
|---|---|---|
| Time to Second- and Third-Line Tumor Progression | 11.2 (9.4 to 12.7) | 13.3 (12.0 to 15.5) |
Second-line PFS was defined as the time from randomization to PD or death due to any cause during their second-line of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
| percentage of participants | CT Arm | CT+BV Arm |
|---|---|---|
| Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 6 | 40.7 (34.3 to 47.0) | 54.2 (47.7 to 60.3) |
Percentage of participants who died due to any reason were reported.
| percentage of participants | CT Arm | CT+BV Arm |
|---|---|---|
| Percentage of Participants Who Died | 63.2 | 66.0 |
OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Participants who had not died were censored at the date the patient was last known to be alive.
| months | CT Arm | CT+BV Arm |
|---|---|---|
| Overall Survival (OS) | 18.7 (15.4 to 21.2) | 19.7 (17.6 to 21.0) |
OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause.
| percentage of participants | CT Arm | CT+BV Arm |
|---|---|---|
| Month 6 | 85.2 (79.9 to 89.2) | 90.4 (85.9 to 93.5) |
| Month 12 | 68.6 (62.0 to 74.3) | 72.4 (66.2 to 77.7) |
| Month 18 | 52.8 (46.0 to 59.3) | 54.9 (48.2 to 61.0) |
| Month 24 | 38.4 (31.8 to 44.9) | 37.6 (31.3 to 43.9) |
The EQ-5D is composed of 5 single-item measures where participants responded to questions assessing health status by responding with either "no problems", "some problems", or "extreme problems" in the following categories: mobility (M) ("no problems"="I have no problems in walking about" to "extreme problems"="I am confined to bed"), self-care (SC) ("no problems"="I have no problems with self-care" to "extreme problems"="I am unable to wash or dress myself"), usual activities (UA) ("no problems"="I have no problems performing my usual activities" to "extreme problems"="I am unable to perform my usual activities"), pain/discomfort (P/D) ("no problems"="I have no pain or discomfort" to "extreme problems"="I have extreme pain or discomfort"), and anxiety/depression (A/D) ("no problems"="I am not anxious or depressed" to "extreme problems"='I am extremely anxious or depressed").
| percentage of participants | CT Arm | CT+BV Arm |
|---|---|---|
| BL: M, no problems (n=214,224) | 60.3 | 64.3 |
| BL: M, some problems (n=214,224) | 36.4 | 34.8 |
| BL: M, extreme problems (n=214,224) | 0.5 | 0.4 |
| BL: SC, no problems (n=214,224) | 82.7 | 85.7 |
| BL: SC, some problems (n=214,224) | 12.6 | 11.2 |
| BL: SC, extreme problems (n=214,224) | 0.5 | 1.8 |
| BL: UA, no problems (n=214,224) | 53.7 | 46.4 |
| BL: UA, some problems (n=214,224) | 40.2 | 48.7 |
| BL: UA, extreme problems (n=214,224) | 2.8 | 4.0 |
| BL: P/D, no problems (n=214,224) | 24.3 | 27.7 |
| BL: P/D, some problems (n=214,224) | 68.7 | 66.1 |
| BL: P/D, extreme problems (n=214,224) | 4.2 | 5.4 |
| BL: A/D, no problems (n=214,224) | 33.6 | 34.8 |
| BL: A/D, some problems (n=214,224) | 56.5 | 58.5 |
| BL: A/D, extreme problems (n=214,224) | 5.6 | 5.8 |
| Week 8/9: M, no problems (n=133,141) | 61.7 | 51.8 |
| Week 8/9: M, some problems (n=133,141) | 34.6 | 43.3 |
| Week 8/9: M, extreme problems (n=133,141) | 1.5 | 2.1 |
| Week 8/9: SC, no problems (n=133,141) | 82.0 | 75.9 |
| Week 8/9: SC, some problems (n=133,141) | 13.5 | 17.0 |
| Week 8/9: SC, extreme problems (n=133,141) | 1.5 | 3.5 |
| Week 8/9: UA, no problems (n=133,141) | 53.4 | 40.4 |
| Week 8/9: UA, some problems (n=133,141) | 40.6 | 51.8 |
| Week 8/9: UA, extreme problems (n=133,141) | 3.0 | 5.0 |
| Week 8/9: P/D, no problems (n=133,141) | 29.3 | 23.4 |
| Week 8/9: P/D, some problems (n=133,141) | 61.7 | 68.1 |
| Week 8/9: P/D, extreme problems (n=133,141) | 5.3 | 6.4 |
| Week 8/9: A/D, no problems (n=133,141) | 49.6 | 46.8 |
| Week 8/9: A/D, some problems (n=133,141) | 40.6 | 48.2 |
| Week 8/9: A/D, extreme problems (n=133,141) | 6.8 | 2.8 |
| Week 16/18: M, no problems (n=84,123) | 66.7 | 49.6 |
| Week 16/18: M, some problems (n=84,123) | 29.8 | 47.2 |
| Week 16/18: M, extreme problems (n=84,123) | 0.0 | 2.4 |
| Week 16/18: SC, no problems (n=84,123) | 81.0 | 78.9 |
| Week 16/18: SC, some problems (n=84,123) | 14.3 | 17.1 |
| Week 16/18: SC, extreme problems (n=84,123) | 0.0 | 3.3 |
| Week 16/18: UA, no problems (n=84,123) | 50.0 | 36.6 |
| Week 16/18: UA, some problems (n=84,123) | 42.9 | 56.1 |
| Week 16/18: UA, extreme problems (n=84,123) | 3.6 | 4.1 |
| Week 16/18: P/D, no problems (n=84,123) | 34.5 | 19.5 |
| Week 16/18: P/D, some problems (n=84,123) | 59.5 | 76.4 |
| Week 16/18: P/D, extreme problems (n=84,123) | 1.2 | 3.3 |
| Week 16/18: A/D, no problems (n=84,123) | 51.2 | 49.6 |
| Week 16/18: A/D, some problems (n=84,123) | 44.0 | 43.1 |
| Week 16/18: A/D, extreme problems (n=84,123) | 0.0 | 5.7 |
| Second-line PD: M, no problems (n=82,76) | 59.8 | 47.4 |
| Second-line PD: M, some problems (n=82,76) | 34.1 | 48.7 |
| Second-line PD: M, extreme problems (n=82,76) | 2.4 | 3.9 |
| Second-line PD: SC, no problems (n=82,76) | 76.8 | 75.0 |
| Second-line PD: SC, some problems (n=82,76) | 15.9 | 18.4 |
| Second-line PD: SC, extreme problems (n=82,76) | 1.2 | 6.6 |
| Second-line PD: UA, no problems (n=82,76) | 39.0 | 30.3 |
| Second-line PD: UA, some problems (n=82,76) | 50.0 | 59.2 |
| Second-line PD: UA, extreme problems (n=82,76) | 6.1 | 10.5 |
| Second-line PD: P/D, no problems (n=82,76) | 19.5 | 18.4 |
| Second-line PD: P/D, some problems (n=82,76) | 67.1 | 69.7 |
| Second-line PD: P/D, extreme problems (n=82,76) | 8.5 | 11.8 |
| Second-line PD: A/D, no problems (n=82,76) | 36.6 | 26.3 |
| Second-line PD: A/D, some problems (n=82,76) | 50.0 | 61.8 |
| Second-line PD: A/D, extreme problems (n=82,76) | 7.3 | 11.8 |
The EQ-5D is composed of 5 single-item measures where participants responded to questions assessing health status by responding with either "no problems", "some problems", or "extreme problems" in the following categories: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Based on large population surveys, an algorithm was used to combine the responses to each of these 5 measures into 1 single EQ-5D index score ranging from -0.59 (extreme problems) to +1 (no problems).
| score on a scale | CT Arm | CT+BV Arm |
|---|---|---|
| BL (n=202,219) | 0.6806 (0.6489 to 0.7122) | 0.6725 (0.6389 to 0.7061) |
| Week 8/9 (n=127,135) | 0.6953 (0.6470 to 0.7437) | 0.6515 (0.6057 to 0.6973) |
| Week 16/18 (n=80,118) | 0.7496 (0.7114 to 0.7879) | 0.6534 (0.6058 to 0.7010) |
| Second-line PD (n=77,76) | 0.6290 (0.5642 to 0.6938) | 0.5553 (0.4736 to 0.6370) |
The EQ-5D is composed of 5 single-item measures where participants responded to questions assessing health status by responding with either "no problems", "some problems", or "extreme problems" in the following categories: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Based on large population surveys, an algorithm was used to combine the responses to each of these 5 measures into 1 single EQ-5D index score ranging from -0.59 (extreme problems) to +1 (no problems) where a negative value indicated a worsening of perceived quality of life and a positive value indicated an improvement of perceived quality of life.
| score on a scale | CT Arm | CT+BV Arm |
|---|---|---|
| Week 8/9 (n=107,122) | -0.0103 (-0.0482 to 0.0276) | -0.0370 (-0.0868 to 0.0127) |
| Week 16/18 (n=68,110) | 0.0387 (-0.0025 to 0.0800) | -0.0508 (-0.1038 to 0.0021) |
| Second-line PD (n=69,71) | -0.0884 (-0.1398 to -0.0371) | -0.0878 (-0.1649 to -0.0107) |
The participant was asked to rate their overall health on a 0-100 millimeter (mm) vertical scale, where the lowest endpoint=0 (labeled as worst imaginable health state) and the highest endpoint =100 (labeled as the best imaginable health state). The participant marked the line corresponding to their assessment and the distance from the bottom was measured in millimeters. A higher value indicated a better health state.
| mm | CT Arm | CT+BV Arm |
|---|---|---|
| BL (n=200,212) | 66.5 (64.1 to 69.0) | 63.4 (60.8 to 65.9) |
| Week 8/9 (n=123,135) | 69.3 (66.4 to 72.1) | 66.5 (63.7 to 69.2) |
| Week 16/18 (n=75,119) | 67.3 (63.3 to 71.3) | 66.4 (63.2 to 69.5) |
| Second-line PD (n=78,75) | 63.7 (59.5 to 68.0) | 61.7 (57.0 to 66.5) |
The participant was asked to rate their overall health on a 0-100 mm vertical scale, where the lowest endpoint = 0 (labeled as worst imaginable health state) and the highest endpoint =100 (labeled as the best imaginable health state). The participant marked the line corresponding to their assessment and the distance from the bottom was measured in millimeters. A negative value indicated a worsening of perceived quality of life and a positive value indicated an improvement of perceived quality of life.
| mm | CT Arm | CT+BV Arm |
|---|---|---|
| Week 8/9 (n=106,118) | -2.0 (-4.8 to 0.9) | 2.0 (-1.4 to 5.3) |
| Week 16/18 (n=66,107) | -0.2 (-4.7 to 4.3) | 2.0 (-1.6 to 5.5) |
| Second-line PD (n=70,69) | -5.1 (-9.1 to -1.0) | -1.3 (-5.5 to 3.0) |
The Functional Assessment of Cancer Therapy-Breast (FACT-B) is composed of 5 multi-item sections where participants responded to questions assessing symptoms (scale: 0-4; 0="not at all" and 4="very much"), as follows: physical well-being (PWB) (7 items, total score 0-28), social/family well-being (SWB) (7 items, total score 0-28), emotional well-being (EWB) (6 items, total score 0-24), functional well-being (FWB) (7 items, total score 0-28); and breast cancer score based on the additional concerns section of FACT-B (10 items, total score 0-40). The FACT-B Trial Outcomes Index (TOI) score=sum of PWB, FWB, and breast cancer score subscale scores (total score 0-96). The Functional Assessment of Cancer Therapy-General (FACT-G) total score=sum of PWB, SWB, EWB, and FWB subscales scores (total score 0-108). The FACT-B total score=sum of PWB, SWB, EWB, FWB, and breast cancer score subscales scores (total score 0-148). In all cases a higher value indicated a better perceived quality of life.
| score on a scale | CT Arm | CT+BV Arm |
|---|---|---|
| BL: PWB (n=215,222) | 20.621 (19.900 to 21.342) | 20.253 (19.500 to 21.006) |
| BL: SWB (n=214,223) | 20.722 (20.028 to 21.416) | 20.674 (19.923 to 21.425) |
| BL: EWB (n=215,224) | 14.847 (14.176 to 15.519) | 15.062 (14.419 to 15.704) |
| BL: FWB (n=215,224) | 16.091 (15.289 to 16.894) | 15.726 (14.951 to 16.502) |
| BL: Breast Cancer Score (n=210,224) | 24.986 (24.103 to 25.869) | 24.388 (23.578 to 25.198) |
| BL: FACT-B TOI (n=204,219) | 61.677 (59.658 to 63.696) | 60.277 (58.365 to 62.189) |
| BL: Total FACT-G Score (n=207,218) | 72.169 (69.919 to 74.419) | 71.864 (69.786 to 73.942) |
| BL: Total FACT-B Score (n=201,218) | 96.908 (94.063 to 99.753) | 96.115 (93.485 to 98.746) |
| Week 8/9: PWB (n=129,138) | 20.413 (19.413 to 21.413) | 19.156 (18.158 to 20.153) |
| Week 8/9: SWB (n=127,135) | 20.833 (19.888 to 21.779) | 21.116 (20.245 to 21.987) |
| Week 8/9: EWB (n=129,139) | 15.943 (15.070 to 16.815) | 16.671 (15.900 to 17.441) |
| Week 8/9: FWB (n=129,139) | 16.662 (15.609 to 17.715) | 16.169 (15.180 to 17.158) |
| Week 8/9: Breast Cancer Score (n=128,139) | 26.276 (25.188 to 27.364) | 25.884 (24.928 to 26.839) |
| Week 8/9: FACT-B TOI (n=126,136) | 63.547 (60.975 to 66.118) | 61.279 (58.811 to 63.747) |
| Week 8/9: Total FACT-G Score (n=122,134) | 74.255 (71.212 to 77.299) | 73.393 (70.603 to 76.184) |
| Week 8/9: Total FACT-B Score (n=123,134) | 100.375 (96.582 to 104.169) | 99.213 (95.667 to 102.760) |
| Week 16/18: PWB (n=83,107) | 21.733 (20.721 to 22.744) | 19.629 (18.571 to 20.688) |
| Week 16/18: SWB (n=80,105) | 20.930 (19.855 to 22.006) | 20.843 (19.829 to 21.857) |
| Week 16/18: EWB (n=80,107) | 17.330 (16.260 to 18.400) | 16.806 (15.961 to 17.650) |
| Week 16/18: FWB (n=81,106) | 17.055 (15.818 to 18.291) | 15.920 (14.787 to 17.053) |
| Week 16/18: Breast Cancer (n=81,106) | 26.923 (25.493 to 28.354) | 25.755 (24.630 to 26.880) |
| Week 16/18: FACT-B TOI (n=78,105) | 65.628 (62.539 to 68.717) | 61.107 (58.309 to 63.905) |
| Week 16/18: Total FACT-G (n=78,102) | 76.794 (73.269 to 80.318) | 73.269 (70.116 to 76.421) |
| Week 16/18: Total FACT-B (n=76,103) | 103.503 (98.819 to 108.187) | 98.906 (94.865 to 102.948) |
| Week 24/27: PWB (n=48,80) | 21.940 (20.599 to 23.282) | 18.965 (17.515 to 20.416) |
| Week 24/27: SWB (n=47,78) | 20.840 (19.468 to 22.211) | 21.399 (20.192 to 22.606) |
| Week 24/27: EWB (n=45,78) | 17.098 (15.719 to 18.477) | 16.438 (15.411 to 17.436) |
| Week 24/27: FWB (n=45,79) | 18.244 (16.754 to 19.734) | 16.051 (14.861 to 17.241) |
| Week 24/27: Breast Cancer (n=46,79) | 26.067 (24.146 to 27.988) | 24.632 (23.231 to 26.033) |
| Week 24/27: FACT-B TOI (n=44,77) | 65.882 (61.991 to 69.653) | 60.014 (56.548 to 63.480) |
| Week 24/27: Total FACT-G (n=44,77) | 78.305 (74.166 to 82.443) | 73.083 (69.365 to 76.801) |
| Week 24/27: Total FACT-B (n=43,77) | 104.011 (98.433 to 109.588) | 97.795 (92.995 to 102.595) |
| Week 32/36: PWB (n=26,44) | 22.949 (21.427 to 24.471) | 19.686 (18.121 to 21.250) |
| Week 32/36: SWB (n=25,43) | 22.140 (20.433 to 23.847) | 21.222 (19.645 to 22.798) |
| Week 32/36: EWB (n=26,44) | 18.385 (16.690 to 20.079) | 16.755 (15.481 to 18.028) |
| Week 32/36: FWB (n=26,44) | 19.615 (17.875 to 21.356) | 17.195 (15.585 to 18.805) |
| Week 32/36: Breast Cancer (n=26,43) | 29.568 (27.722 to 31.415) | 26.163 (24.457 to 27.869) |
| Week 32/36: FACT-B TOI (n=26,42) | 72.132 (68.549 to 75.716) | 63.017 (59.199 to 66.836) |
| Week 32/36: Total FACT-G (n=25,42) | 83.087 (78.178 to 87.995) | 74.879 (70.566 to 79.191) |
| Week 32/36: Total FACT-B (n=25,42) | 112.904 (107.315 to 118.494) | 100.904 (95.302 to 106.506) |
| Week 40/45: PWB (n=20,27) | 22.215 (20.583 to 23.847) | 20.630 (18.820 to 22.440) |
| Week 40/45: SWB (n=21,26) | 19.658 (17.955 to 21.361) | 20.915 (19.146 to 22.685) |
| Week 40/45: EWB (n=20,27) | 17.560 (15.708 to 19.412) | 16.067 (13.875 to 18.259) |
| Week 40/45: FWB (n=20,27) | 18.450 (16.120 to 20.780) | 16.519 (13.901 to 19.136) |
| Week 40/45: Breast Cancer (n=21,27) | 29.386 (27.156 to 31.616) | 23.819 (21.013 to 26.625) |
| Week 40/45: FACT-B TOI (n=19,27) | 68.750 (63.981 to 73.518) | 60.967 (55.065 to 66.870) |
| Week 40/45: Total FACT-G (n=19,26) | 76.955 (71.480 to 82.430) | 75.235 (68.901 to 81.568) |
| Week 40/45: Total FACT-B (n=19,26) | 105.540 (98.512 to 112.568) | 99.072 (90.613 to 107.531) |
| Week 48/54: PWB (n=13,24) | 23.308 (21.283 to 25.333) | 20.033 (18.124 to 21.943) |
| Week 48/54: SWB (n=13,23) | 20.740 (18.953 to 22.527) | 20.450 (18.310 to 22.590) |
| Week 48/54: EWB (n=13,23) | 19.308 (17.522 to 21.093) | 17.270 (15.494 to 19.045) |
| Week 48/54: FWB (n=13,23) | 18.538 (16.586 to 20.491) | 16.268 (13.949 to 18.587) |
| Week 48/54: Breast Cancer (n=13,23) | 28.912 (26.879 to 30.945) | 26.237 (22.842 to 29.632) |
| Week 48/54: Fact-B TOI (n=13,23) | 70.758 (66.403 to 75.114) | 62.679 (55.941 to 69.418) |
| Week 48/54: Total FACT-G (n=13,23) | 81.894 (76.424 to 87.363) | 74.162 (67.865 to 80.458) |
| Week 48/54: Total FACT-B (n=13,23) | 110.806 (104.704 to 116.908) | 100.399 (91.294 to 109.503) |
| Week 56/63: PWB (n=8,14) | 21.792 (18.958 to 24.626) | 20.298 (17.412 to 23.184) |
| Week 56/63: SWB (n=8,14) | 19.583 (15.598 to 23.569) | 20.817 (17.629 to 24.004) |
| Week 56/63: EWB (n=7,14) | 17.143 (13.389 to 20.897) | 15.714 (12.606 to 18.823) |
| Week 56/63: FWB (n=7,14) | 17.143 (13.876 to 20.410) | 16.476 (12.633 to 20.319) |
| Week 56/63: Breast Cancer (n=8,14) | 28.240 (23.931 to 32.548) | 25.459 (21.407 to 29.512) |
| Week 56/63: FACT-B TOI (n=7,14) | 66.179 (55.888 to 76.469) | 62.233 (53.524 to 70.942) |
| Week 56/63: Total FACT-G (n=6,14) | 73.667 (58.381 to 88.952) | 73.305 (62.863 to 83.746) |
| Week 56/63: Total FACT-B (n=6,14) | 101.042 (81.841 to 120.242) | 98.764 (85.368 to 112.160) |
| Week 64/72: PWB (n=7,9) | 21.857 (17.376 to 26.338) | 21.889 (19.569 to 24.209) |
| Week 64/72: SWB (n=7,9) | 18.976 (16.352 to 21.600) | 22.685 (19.417 to 25.953) |
| Week 64/72: EWB (n=7,9) | 18.143 (13.758 to 22.527) | 17.889 (14.274 to 21.503) |
| Week 64/72: FWB (n=7,9) | 18.429 (14.658 to 22.199) | 16.037 (12.890 to 19.184) |
| Week 64/72: Breast Cancer (n=7,9) | 27.464 (22.941 to 31.988) | 26.889 (22.584 to 31.194) |
| Week 64/72: FACT-B TOI (n=7,9) | 67.750 (56.306 to 79.194) | 64.815 (56.516 to 73.114) |
| Week 64/72: Total FACT-G (n=7,9) | 77.405 (63.847 to 90.963) | 78.500 (68.852 to 88.148) |
| Week 64/72: Total FACT-B (n=7,9) | 104.869 (87.586 to 122.152) | 105.389 (92.415 to 118.363) |
| Week 72/81: PWB (n=6,7) | 23.083 (18.906 to 27.260) | 21.000 (16.407 to 25.593) |
| Week 72/81: SWB (n=5,7) | 19.667 (16.238 to 23.095) | 20.043 (14.019 to 26.067) |
| Week 72/81: EWB (n=6,7) | 17.500 (13.476 to 21.524) | 18.114 (14.130 to 22.098) |
| Week 72/81: FWB (n=6,7) | 17.333 (14.316 to 20.351) | 16.429 (11.339 to 21.518) |
| Week 72/81: Breast Cancer (n=6,6) | 28.597 (24.421 to 32.774) | 25.333 (20.250 to 30.417) |
| Week 72/81: FACT-B TOI (n=6,6) | 69.014 (59.566 to 78.462) | 60.833 (47.031 to 74.635) |
| Week 72/81: Total FACT-G (n=5,7) | 76.467 (62.045 to 90.889) | 75.586 (57.141 to 94.030) |
| Week 72/81: Total FACT-B (n=5,6) | 106.117 (88.146 to 124.087) | 97.211 (73.196 to 121.226) |
| Week 80/90: PWB (n=2,3) | 19.250 (-32.634 to 71.134) | 18.000 (2.487 to 33.513) |
| Week 80/90: SWB (n=2,3) | 18.375 (7.257 to 29.493) | 19.944 (3.434 to 36.455) |
| Week 80/90: EWB (n=2,3) | 14.000 (-49.531 to 77.531) | 15.733 (-3.285 to 34.752) |
| Week 80/90: FWB (n=2,3) | 15.000 (-35.825 to 65.825) | 12.333 (-1.348 to 26.015) |
| Week 80/90: Breast Cancer (n=2,3) | 21.667 (0.490 to 42.844) | 25.000 (14.172 to 35.828) |
| Week 80/90: FACT-B TOI (n=2,3) | 55.917 (-67.969 to 179.802) | 55.333 (20.085 to 90.581) |
| Week 80/90: Total FACT-G (n=2,3) | 66.625 (-110.732 to 243.982) | 66.011 (2.191 to 129.831) |
| Week 80/90: Total FACT-B (n=2,3) | 88.292 (-110.243 to 286.826) | 91.011 (20.313 to 161.709) |
| Week 88/99: PWB (n=0,1) | NA (NA to NA) | 22.000 (NA to NA) |
| Week 88/99: SWB (n=0,1) | NA (NA to NA) | 23.333 (NA to NA) |
| Week 88/99: EWB (n=0,1) | NA (NA to NA) | 20.000 (NA to NA) |
| Week 88/99: FWB (n=0,1) | NA (NA to NA) | 21.000 (NA to NA) |
| Week 88/99: Breast Cancer (n=0,1) | NA (NA to NA) | 35.000 (NA to NA) |
| Week 88/99: FACT-B TOI (n=0,1) | NA (NA to NA) | 78.000 (NA to NA) |
| Week 88/99: Total FACT-G (n=0,1) | NA (NA to NA) | 86.333 (NA to NA) |
| Week 88/99: Total FACT-B (n=0,1) | NA (NA to NA) | 121.333 (NA to NA) |
| Week 96/108: PWB (n=2,1) | 26.000 (NA to NA) | 22.000 (NA to NA) |
| Week 96/108: SWB (n=2,1) | 24.383 (-3.782 to 52.549) | 21.000 (NA to NA) |
| Week 96/108: EWB (n=2,2) | 22.000 (9.294 to 34.706) | 18.000 (-7.412 to 43.412) |
| Week 96/108: FWB (n=2,2) | 21.083 (7.318 to 34.848) | 10.500 (-46.678 to 67.678) |
| Week 96/108: Breast Cancer (n=2,2) | 30.389 (-2.788 to 63.566) | 24.500 (-7.266 to 56.266) |
| Week 96/108: FACT-B TOI (n=2,1) | 77.472 (58.060 to 96.884) | 59.000 (NA to NA) |
| Week 96/108: Total FACT-G (n=2,1) | 93.467 (38.830 to 148.103) | 74.000 (NA to NA) |
| Week 96/108: Total FACT-B (n=2,1) | 123.856 (102.396 to 145.315) | 96.000 (NA to NA) |
| Week 104/117: PWB (n=1,3) | 27.000 (NA to NA) | 21.333 (17.539 to 25.128) |
| Week 104/117: SWB (n=1,2) | 26.600 (NA to NA) | 20.5000 (14.147 to 26.853) |
| Week 104/117: EWB (n=1,3) | 22.000 (NA to NA) | 18.000 (6.616 to 29.384) |
| Week 104/117: FWB (n=1,3) | 22.000 (NA to NA) | 11.000 (-1.908 to 23.908) |
| Week 104/117: Breast Cancer (n=1,3) | 27.143 (NA to NA) | 28.000 (19.395 to 36.605) |
| Week 104/117: FACT-B TOI (n=1,3) | 76.143 (NA to NA) | 60.333 (45.778 to 74.889) |
| Week 104/117: Total FACT-G (n=1,2) | 97.600 (NA to NA) | 70.500 (-50.209 to 191.209) |
| Week 104/117: Total FACT-B (n=1,2) | 124.743 (NA to NA) | 100.500 (-20.209 to 221.209) |
| Week 112/126: PWB (n=0,1) | NA (NA to NA) | 14.000 (NA to NA) |
| Week 112/126: SWB (n=0,1) | NA (NA to NA) | 15.400 (NA to NA) |
| Week 112/126: EWB (n=0,1) | NA (NA to NA) | 15.000 (NA to NA) |
| Week 112/126: FWB (n=0,1) | NA (NA to NA) | 11.000 (NA to NA) |
| Week 112/126: Breast Cancer (n=0,1) | NA (NA to NA) | 20.000 (NA to NA) |
| Week 112/126: FACT-B TOI (n=0,1) | NA (NA to NA) | 45.000 (NA to NA) |
| Week 112/126: Total FACT-G (n=0,1) | NA (NA to NA) | 55.400 (NA to NA) |
| Week 112/126: Total FACT-B (n=0,1) | NA (NA to NA) | 75.400 (NA to NA) |
| Second-Line PD: PWB (n=89,81) | 19.086 (17.873 to 20.299) | 17.412 (15.977 to 18.846) |
| Second-Line PD: SWB (n=88,79) | 20.623 (19.456 to 21.790) | 21.487 (20.335 to 22.639) |
| Second-Line PD: EWB (n=88,80) | 15.111 (14.102 to 16.121) | 14.175 (12.872 to 15.478) |
| Second-Line PD: FWB (n=88,80) | 15.447 (14.122 to 16.772) | 15.235 (13.877 to 16.593) |
| Second-Line PD: Breast Cancer (n=85,81) | 24.978 (23.602 to 26.354) | 24.445 (22.989 to 25.901) |
| Second-Line PD: FACT-B TOI (n=84,80) | 59.230 (56.033 to 62.428) | 57.002 (53.234 to 60.770) |
| Second-Line PD: Total FACT-G (n=86,78) | 69.829 (66.264 to 73.393) | 68.485 (64.384 to 72.586) |
| Second-Line PD: Total FACT-B (n=82,78) | 94.930 (90.240 to 99.619) | 92.983 (87.645 to 98.320) |
The FACT-B is composed of 5 multi-item sections where participants responded to questions assessing symptoms (scale: 0-4; 0="not at all" and 4="very much"), as follows: PWB (7 items, total score 0-28), SWB (7 items, total score 0-28), EWB (6 items, total score 0-24), FWB (7 items, total score 0-28); and breast cancer score based on the additional concerns section of FACT-B (10 items, total score 0-40). The FACT-B TOI score=sum of PWB, FWB, and breast cancer score subscale scores (total score 0-96). The FACT-G total score=sum of PWB, SWB, EWB, and FWB subscales scores (total score 0-108). The FACT-B total score=sum of PWB, SWB, EWB, FWB, and breast cancer score subscale scores (total score 0-148). In all cases a higher value indicated a better perceived quality of life.
| score on a scale | CT Arm | CT+BV Arm |
|---|---|---|
| Week 8/9: PWB (n=118,125) | -1.281 (-2.219 to -0.344) | -1.289 (-2.239 to -0.338) |
| Week 8/9: SWB (n=116,125) | 0.356 (-0.283 to 0.994) | 0.707 (-0.226 to 1.640) |
| Week 8/9: EWB (n=116,128) | 0.408 (-0.274 to 1.089) | 1.024 (0.314 to 1.734) |
| Week 8/9: FWB (n=117,128) | -0.226 (-1.043 to 0.591) | -0.240 (-1.027 to 0.548) |
| Week 8/9: Breast Cancer Score (n=113,128) | 0.228 (-0.659 to 1.116) | 0.950 (0.121 to 1.780) |
| Week 8/9: FACT-B TOI (n=110,122) | -1.361 (-3.295 to 0.573) | -0.357 (-2.407 to 1.693) |
| Week 8/9: Total FACT-G Score (n=110,122) | -0.760 (-2.920 to 1.399) | 0.369 (-1.945 to 2.684) |
| Week 8/9: Total FACT-B Score (n=108,120) | -0.728 (-3.332 to 1.876) | 1.342 (-1.544 to 4.229) |
| Week 16/18: PWB (n=77,97) | 0.294 (-0,733 to 1.322) | -1.823 (-2.871 to -0.775) |
| Week 16/18: SWB (n=74,97) | -0.443 (-1.411 to 0.525) | 0.359 (-0.678 to 1.397) |
| Week 16/18: EWB (n=73,98) | 1.197 (0.415 to 1.979) | 0.921 (0.186 to 1.657) |
| Week 16/18: FWB (n=75,98) | -0.548 (-1.666 to 0.570) | -0.517 (-1.422 to 0.389) |
| Week 16/18: Breast Cancer (n=72,97) | 0.578 (-0.658 to 1.815) | 0.546 (-0.423 to 1.514) |
| Week 16/18: FACT-TOI (n=68,95) | -0.483 (-3.149 to 2.183) | -1.732 (-4.049 to 0.586) |
| Week 16/18: Total FACT-G (n=71,93) | -0.019 (-2.970 to 2.931) | -0.836 (-3.494 to 1.821) |
| Week 16/18: Total Fact-B (n=66,93) | -0.007 (-3.744 to 3.730) | -0.127 (-3.421 to 3.167) |
| Week 24/27: PWB (n=44,73) | 0.181 (-1.236 to 1.598) | -1.996 (-3.306 to -0.685) |
| Week 24/27: SWB (n=44,72) | -0.193 (-1.490 to 1.104) | 1.375 (-0.001 to 2.750) |
| Week 24/27: EWB (n=42,72) | 0.867 (-0.101 to 1.834) | 1.217 (0.366 to 2.067) |
| Week 24/27: FWB (n=42,72) | 0.119 (-1.405 to 1.643) | 0.056 (-1.053 to 1.166) |
| Week 24/27: Breast Cancer (n=40,72) | -0.038 (-1.723 to 1.647) | 0.078 (-1.106 to 1.262) |
| Week 24/27: FACT-B TOI (n=38,70) | 0.221 (-3.411 to 3.853) | -1.573 (-4.383 to 1.238) |
| Week 24/27: Total FACT-G (n=40,70) | 0.764 (-3.066 to 4.595) | 0.817 (-2.497 to 4.131) |
| Week 24/27: Total FACT-B (n=37,70) | 0.793 (-4.106 to 5.693) | 1.157 (-2.828 to 5.142) |
| Week 32/36: PWB (n=25,39) | 0.880 (-0.913 to 2.673) | -1.235 (-2.799 to 0.329) |
| Week 32/36: SWB (n=24,40) | -0.388 (-1.754 to 0.979) | 1.036 (-1.209 to 3.281) |
| Week 32/36: EWB (n=25,40) | 1.064 (-0.298 to 2.426) | 1.555 (0.204 to 2.906) |
| Week 32/36: FWB (n=25,40) | 1.380 (-0.103 to 2.863) | 1.635 (-0.201 to 3.471) |
| Week 32/36: Breast Cancer (n=23,40) | 0.928 (-1.916 to 3.771) | 1.278 (-0.435 to 2.990) |
| Week 32/36: FACT-B TOI (n=23,38) | 3.123 (-1.390 to 7.637) | 1.471 (-2.522 to 5.464) |
| Week 32/36: Total FACT-G (n=24,39) | 2.617 (-1.313 to 6.547) | 3.197 (-1.346 to 7.740) |
| Week 32/36: Total FACT-B (n=22,38) | 3.529 (-2.074 to 9.132) | 3.896 (-1.579 to 9.370) |
| Week 40/45: PWB (n=18,25) | 0.137 (-2.051 to 2.325) | -0.680 (-2.930 to 1.570) |
| Week 40/45: SWB (n=19,24) | -0.589 (-2.436 to 1.259) | 0.951 (-1.590 to 3.492) |
| Week 40/45: EWB (n=18,25) | 0.200 (-1.598 to 1.998) | 1.048 (-0.658 to 2.754) |
| Week 40/45: FWB (n=18,25) | 1.417 (-0.562 to 3.395) | 0.857 (-0.893 to 2.608) |
| Week 40/45: Breast Cancer (n=18,25) | 1.395 (-1.268 to 4.058) | 0.444 (-2.358 to 3.247) |
| Week 40/45: FACT-B TOI (n=16,25) | 2.432 (-2.496 to 7.360) | 0.622 (-4.688 to 5.932) |
| Week 40/45: Total FACT-G (n=17,24) | 1.444 (-3.342 to 6.231) | 2.432 (-3.035 to 7.899) |
| Week 40/45: Total FACT-B (n=16,24) | 1.916 (-3.950 to 7.782) | 2.673 (-4.258 to 9.603) |
| Week 48/54: PWB (n=13,20) | 1.295 (-2.037 to 4.627) | -1.833 (-3.721 to 0.055) |
| Week 48/54: SWB (n=13,20) | 1.529 (-0.316 to 3.375) | 2.008 (-1.083 to 5.099) |
| Week 48/54: EWB (n=13,20) | 1.492 (0.492 to 2.492) | 1.710 (-0.183 to 3.603) |
| Week 48/54: FWB (n=13,20) | 2.269 (0.174 to 4.365) | 1.592 (-0.872 to 4.055) |
| Week 48/54: Breast Cancer (n=12,20) | 0.599 (-1.714 to 2.912) | 1.897 (-0.463 to 4.258) |
| Week 48/54: FACT-B TOI (n=12,20) | 4.044 (-2.832 to 10.919) | 1.656 (-3.691 to 7.002) |
| Week 48/54: Total FACT-G (n=13,20) | 6.586 (1.392 to 11.780) | 3.477 (-2.596 to 9.550) |
| Week 48/54: Total FACT-B (n=12,20) | 7.067 (0.241 to 13.894) | 5.374 (-2.391 to 13.139) |
| Week 56/63: PWB (n=8,13) | -2.063 (-6.094 to 1.969) | -0.526 (-3.996 to 2.944) |
| Week 56/63: SWB (n=8,13) | -1.500 (-5.699 to 2.699) | 3.033 (-1.729 to 7.796) |
| Week 56/63: EWB (n=7,13) | 0.857 (-2.781 to 4.495) | 0.954 (-2.190 to 4.097) |
| Week 56/63: FWB (n=7,13) | 0.000 (-4.835 to 4.835) | 5.654 (0.511 to 10.797) |
| Week 56/63: Breast Cancer (n=8,13) | -0.830 (-6.133 to 4.474) | 1.675 (-1.291 to 4.641) |
| Week 56/63: FACT-B TOI (n=7,13) | -3.591 (-17.803 to 10.621) | 6.803 (1.093 to 14.699) |
| Week 56/63: Total FACT-G (n=6,13) | -4.083 (-22.930 to 14.764) | 9.115 (-3.820 to 22.050) |
| Week 56/63: Total FACT-B (n=6,13) | -5.301 (-29.740 to 19.138) | 10.791 (-3.114 to 24.695) |
| Week 64/72: PWB (n=7,9) | 0.000 (-6.733 to 6.733) | 0.926 (-1.491 to 3.342) |
| Week 64/72: SWB (n=7,9) | -2.014 (-5.182 to 1.154) | 3.570 (-1.034 to 8.174) |
| Week 64/72: EWB (n=7,9) | -0.057 (-3.537 to 3.423) | 3.667 (-0.630 to 7.964) |
| Week 64/72: FWB (n=7,9) | 0.214 (-4.531 to 4.959) | 3.222 (-2.143 to 8.588) |
| Week 64/72: Breast Cancer (n=7,9) | -2.298 (-7.507 to 2.912) | 3.086 (-1.361 to 7.534) |
| Week 64/72: FACT-B TOI (n=7,9) | -2.083 (-17.130 to 12.963) | 7.235 (-3.624 to 18.093) |
| Week 64/72: Total FACT-G (n=7,9) | -1.857 (-17.855 to 14.140) | 11.385 (-3.116 to 25.886) |
| Week 64/72: Total FACT-B (n=7,9) | -4.155 (-24.302 to 15.993) | 14.472 (-4.192 to 33.135) |
| Week 72/81: PWB (n=5,7) | 2.133 (-6.045 to 10.311) | -0.429 (-3.965 to 3.108) |
| Week 72/81: SWB (n=4,7) | -1.208 (-5.126 to 2.710) | 6.829 (-3.189 to 16.846) |
| Week 72/81: EWB (n=5,7) | -0.600 (-5.042 to 3.842) | 4.686 (-0.608 to 9.979) |
| Week 72/81: FWB (n=5,7) | 0.000 (-5.341 to 5.341) | 7.381 (-1.169 to 15.931) |
| Week 72/81: Breast Cancer (n=5,6) | -0.461 (-6.531 to 5.609) | 3.667 (-3.410 to 10.743) |
| Week 72/81: FACT-B TOI (n=5,6) | 1.672 (-12.563 to 15.907) | 8.278 (-7.450 to 24.005) |
| Week 72/81: Total FACT-G (n=4,7) | -0.167 (-22.161 to 21.828) | 18.467 (-1.867 to 38.801) |
| Week 72/81: Total FACT-B (n=4,6) | 1.174 (-23.085 to 25.432) | 16.906 (-9.207 to 43.018) |
| Week 80/90: PWB (n=2,3) | -3.750 (-30.221 to 22.721) | -3.000 (-11.605 to 5.605) |
| Week 80/90: SWB (n=2,3) | -0.875 (-34.229 to 32.479) | 7.344 (-9.614 to 24.303) |
| Week 80/90: EWB (n=2,3) | -4.000 (-42.119 to 34.119) | 4.733 (-18.466 to 27.932) |
| Week 80/90: FWB (n=2,3) | -1.000 (-64.531 to 62.531) | 2.556 (-9.165 to 14.276) |
| Week 80/90: Breast Cancer (n=2,3) | -5.833 (-29.128 to 17.461) | 3.667 (-11.512 to 18.845) |
| Week 80/90: FACT-B TOI (n=2,3) | -10.583 (-77.291 to 56.124) | 3.222 (-30.212 to 36.657) |
| Week 80/90: Total FACT-G (n=2,3) | -9.625 (-171.100 to 151.850) | 11.633 (-41.554 to 64.821) |
| Week 80/90: Total FACT-B (n=2,3) | -15.458 (-153.638 to 122.722) | 15.300 (-48.177 to 78.777) |
| Week 88/99: PWB (n=0,1) | NA (NA to NA) | -6.000 (NA to NA) |
| Week 88/99: SWB (n=0,1) | NA (NA to NA) | 23.333 (NA to NA) |
| Week 88/99: EWB (n=0,1) | NA (NA to NA) | 0.000 (NA to NA) |
| Week 88/99: FWB (n=0,1) | NA (NA to NA) | 21.000 (NA to NA) |
| Week 88/99: Breast Cancer (n=0,1) | NA (NA to NA) | 3.000 (NA to NA) |
| Week 88/99: FACT TOI (n=0,1) | NA (NA to NA) | 18.000 (NA to NA) |
| Week 88/99: Total FACT-G (n=0,1) | NA (NA to NA) | 38.333 (NA to NA) |
| Week 88/99: Total FACT-B (n=0,1) | NA (NA to NA) | 41.333 (NA to NA) |
| Week 96/108: PWB (n=2,1) | 7.333 (-51.962 to 66.629) | -3.000 (NA to NA) |
| Week 96/108: SWB (n=2,1) | 2.183 (-23.441 to 27.808) | 1.400 (NA to NA) |
| Week 96/108: EWB (n=2,1) | 0.000 (-12.706 to 12.706) | 6.000 (NA to NA) |
| Week 96/108: FWB (n=2,1) | 6.583 (-13.535 to 26.701) | -1.333 (NA to NA) |
| Week 96/108: Breast Cancer (n=2,1) | 3.167 (-41.305 to 47.638) | -3.000 (NA to NA) |
| Week 96/108: FACT-B TOI (n=2,1) | 17.083 (11.789 to 22.378) | -7.333 (NA to NA) |
| Week 96/108: Total FACT-G (n=2,1) | 16.100 (15.253 to 16.947) | 3.067 (NA to NA) |
| Week 96/108: Total FACT-B (n=2,1) | 19.267 (-24.358 to 62.891) | 0.067 (NA to NA) |
| Week 104/117: PWB (n=1,2) | 3.667 (NA to NA) | -2.000 (-40.119 to 36.119) |
| Week 104/117: SWB (n=1,1) | 4.200 (NA to NA) | 8.800 (NA to NA) |
| Week 104/117: EWB (n=1,2) | 0.000 (NA to NA) | 10.000 (-28.119 to 48.119) |
| Week 104/117: FWB (n=1,2) | 8.000 (NA to NA) | 2.333 (-56.962 to 61.629) |
| Week 104/117: Breast Cancer (n=1,2) | 6.032 (NA to NA) | 4.000 (-59.531 to 67.531) |
| Week 104/117: FACT-B TOI (n=1,2) | 17.698 (NA to NA) | 4.333 (-156.612 to 165.279) |
| Week 104/117: Total FACT-G (n=1,1) | 15.867 (NA to NA) | 29.800 (NA to NA) |
| Week 104/117: Total GACT-B (n=1,1) | 21.898 (NA to NA) | 38.800 (NA to NA) |
| Week 112/126: PWB (n=0,1) | NA (NA to NA) | -11.000 (NA to NA) |
| Week 112/126: SWB (n=0,1) | NA (NA to NA) | -4.200 (NA to NA) |
| Week 112/126: EWB (n=0,1) | NA (NA to NA) | 5.000 (NA to NA) |
| Week 112/126: FWB (n=0,1) | NA (NA to NA) | -5.333 (NA to NA) |
| Week 112/126: Breast Cancer (n=0,1) | NA (NA to NA) | -5.000 (NA to NA) |
| Week 112/126: FACT-B TOI (n=0,1) | NA (NA to NA) | -21.333 (NA to NA) |
| Week 112/126: Total FACT-G (n=0,1) | NA (NA to NA) | -15.533 (NA to NA) |
| Week 112/126: Total FACT-B (n=0,1) | NA (NA to NA) | -20.533 (NA to NA) |
| Second-Line PD: PWB (n=81,77) | -0.871 (-1.916 to 0.174) | -2.507 (-3.783 to -1.231) |
| Second-Line PD: SWB (n=80,75) | -0.106 (-0.902 to 0.690) | -0.766 (-1.788 to 0.256) |
| Second-Line PD: EWB (n=80,76) | -0.440 (-1.553 to 0.673) | -0.508 (-1.562 to 0.546) |
| Second-Line PD: FWB (n=80,76) | -1.415 (-2.590 to -0.239) | -0.773 (-1.809 to 0.263) |
| Second-Line PD: Breast Cancer (n=77,77) | 0.120 (-1.182 to 1.421) | 0.241 (-0.878 to 1.360) |
| Second-Line PD: FACT-B TOI (n=74,76) | -2.311 (-5.070 to 0.447) | -3.003 (-5.734 to -0.273) |
| Second-Line PD: Total FACT-G (n=76,74) | -2.771 (-5.902 to 0.361) | -4.702 (-7.941 to -1.462) |
| Second-Line PD: Total FACT-B (n=72,74) | -2.719 (-6.633 to 1.195) | -4.440 (-8.515 to -0.366) |
Second-line PFS was defined as the time from randomization to PD or death due to any cause during their second-line of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without secondline PD or death were censored at the date of last tumor assessment where non-progression was documented.
| percentage of participants | CT Arm | CT+BV Arm |
|---|---|---|
| Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 12 | 16.9 (12.3 to 22.2) | 24.2 (19.0 to 29.9) |
Second-line PFS was defined as the time from randomization to PD or death due to any cause during their secondline of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
| percentage of participants | CT Arm | CT+BV Arm |
|---|---|---|
| Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 18 | 9.9 (6.4 to 14.3) | 11.0 (7.4 to 15.5) |
Second-line PFS was defined as the time from randomization to PD or death due to any cause during their second-line of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
| percentage of participants | CT Arm | CT+BV Arm |
|---|---|---|
| Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 24 | 6.4 (3.6 to 10.2) | 6.5 (3.7 to 10.2) |
Collected over Baseline up to approximately 4 years.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CT Arm | — | 55/238 (23.1%) | 181/238 (76.1%) |
| CT+BV Arm | — | 89/245 (36.3%) | 218/245 (89%) |
| Event | CT Arm | CT+BV Arm |
|---|---|---|
| Febrile neutropeniaBlood and lymphatic system disorders | 5/238 | 12/245 |
| NeutropeniaBlood and lymphatic system disorders | 6/238 | 10/245 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 2/238 | 6/245 |
| ThrombocytopeniaBlood and lymphatic system disorders | 0/238 | 5/245 |
| PyrexiaGeneral disorders | 2/238 | 4/245 |
| DiarrhoeaGastrointestinal disorders | 2/238 | 4/245 |
| InfectionInfections and infestations | 2/238 | 3/245 |
| BronchitisInfections and infestations | 0/238 | 3/245 |
| Mucosal inflammationGeneral disorders | 1/238 | 3/245 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 1/238 | 3/245 |
| Event | CT Arm | CT+BV Arm |
|---|---|---|
| ProteinuriaRenal and urinary disorders | 70/238 | 133/245 |
| HypertensionVascular disorders | 55/238 | 90/245 |
| Palmar-plantar erythrodysaesthesia syndromeSkin and subcutaneous tissue disorders | 58/238 | 72/245 |
| NeutropeniaBlood and lymphatic system disorders | 55/238 | 64/245 |
| FatigueGeneral disorders | 33/238 | 49/245 |
| DiarrhoeaGastrointestinal disorders | 27/238 | 35/245 |
| NauseaGastrointestinal disorders | 31/238 | 33/245 |
| LeukopeniaBlood and lymphatic system disorders | 18/238 | 30/245 |
| HaemorrhageVascular disorders | 7/238 | 29/245 |
| Mucosal inflammationGeneral disorders | 9/238 | 26/245 |
Intent-to-treat (ITT) population: all randomized participants.
| Age, Continuous(years) | CT Arm | CT+BV Arm | Total |
|---|---|---|---|
| Mean | 54.7 ± 10.83 | 55.8 ± 11.17 | 55.2 ± 11.01 |
| Sex: Female, Male(Participants) | CT Arm | CT+BV Arm | Total |
|---|---|---|---|
| Female | 247 | 247 | 494 |
| Male | 0 | 0 | 0 |
Showing the first 100 of 132 sites across 13 countries.
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hoffmann-La Roche