A Phase 3 interventional study of Trastuzumab Emtansine and Trastuzumab in Breast Cancer, sponsored by Hoffmann-La Roche. Completed at 295 sites in 36 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-14.
Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment
This two-arm, randomized, open-label, multicenter study will evaluate the efficacy and safety of trastuzumab emtansine in combination with pertuzumab versus trastuzumab in combination with pertuzumab and a taxane as adjuvant therapy in participants with human epidermal growth (HER) factor 2 (HER2)-positive primary invasive breast cancer. Following surgery and anthracycline-based chemotherapy, participants will receive either trastuzumab emtansine at a dose of 3.6 milligrams per kilogram (mg/kg) and pertuzumab at a dose of 420 milligrams (mg) intravenously (IV) every 3 weeks (q3w) or trastuzumab at a dose of 6 mg/kg and pertuzumab at a dose of 420 mg IV q3w in combination with a taxane.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 1,846 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.
Node-positive disease (pN more than or equal to [>/=] 1), any tumor size except T0, and any hormonal receptor status; or Node-negative disease (pN0) with pathologic tumor size >2.0 centimeters by standard local assessment and negative for estrogen receptor (ER) and progesterone receptor (PR) determined by a central pathology laboratory
Exclusion Criteria:
Trastuzumab and pertuzumab will be administered concurrently for up to a total duration of 1 year (up to 18 cycles \[1 Cycle = 21 days\]) with the taxane (docetaxel or paclitaxel) component of chemotherapy following anthracycline \[5 fluorouracil, epirubicin, and cyclophosphamide (FEC) or epirubicin and cyclophosphamide (EC) or doxorubicin and cyclophosphamide (AC)\] based chemotherapy.
Drug: Trastuzumab · Drug: Pertuzumab · Drug: Paclitaxel · Drug: Epirubicin · Drug: Doxorubicin · Drug: Docetaxel · Drug: Cyclophosphamide · Drug: 5-Fluorouracil
Trastuzumab emtansine and pertuzumab will continue for up to a total duration of 1 year (up to 18 cycles \[1 Cycle = 21 days\]) following anthracycline \[5 fluorouracil, epirubicin, and cyclophosphamide (FEC) or epirubicin and cyclophosphamide (EC) or doxorubicin and cyclophosphamide (AC)\] based chemotherapy.
Drug: Trastuzumab Emtansine · Drug: Epirubicin · Drug: Doxorubicin · Drug: Cyclophosphamide · Drug: 5-Fluorouracil
Trastuzumab emtansine IV infusion (duration 90 minutes) will be administered at 3.6 mg/kg q3w for up to 18 cycles (1 cycle = 21 days).
Also known as: Kadcyla
Trastuzumab IV infusion (duration 90 minutes) will be administered at 8 mg/kg loading dose followed by 6 mg/kg IV q3w for up to 18 cycles (1 cycle = 21 days).
Also known as: Herceptin
Pertuzumab infusion (duration 60 minutes) will be administered at 840 mg loading dose followed by 420 mg IV q3w for up to 18 cycles (1 cycle = 21 days).
Also known as: Perjeta
IV infusion of paclitaxel 80 mg/m\^2 once weekly may be administered concurrently with trastuzumab in combination with pertuzumab for 12 weeks.
3 to 4 cycles (1 cycle = 21 days) of standard of care anthracycline-based chemotherapy using epirubicin may be administered in both Arms 1 and 2 as per discretion of the investigator and local prescribing information/institutional guidelines.
3 to 4 cycles (1 cycle = 21 days) of standard of care anthracycline-based chemotherapy using doxorubicin may be administered in both Arms 1 and 2 as per discretion of the investigator and local prescribing information/institutional guidelines.
IV infusion either docetaxel every 3 weeks (q3w) (at 100 milligram per square meter \[mg/m\^2\] for 3 cycles (1 cycle = 21 days); at 75 mg/m2 for 4 cycles; or start at 75 mg/m\^2 in the first cycle and escalate to 100 mg/m\^2 if no dose limiting toxicity occurs, for a total of 3 cycles at minimum) may be administered concurrently with trastuzumab in combination with pertuzumab.
3 to 4 cycles (1 cycle = 21 days) of standard of care anthracycline-based chemotherapy using cyclophosphamide (FEC) may be administered in both Arms 1 and 2 as per discretion of the investigator and local prescribing information/institutional guidelines.
3 to 4 cycles (1 cycle = 21 days) of standard of care anthracycline-based chemotherapy using 5-fluorouracil, may be administered in both Arms 1 and 2 as per discretion of the investigator and local prescribing information/institutional guidelines.
Invasive Disease-Free Survival (IDFS) in the Node-Positive Subpopulation
IDFS event was defined as the time from randomization until the date of first occurrence of one of the following: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer \[bc\] involving the same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive bc recurrence (an invasive bc in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); Contralateral or ipsilateral second primary invasive bc; Distant recurrence (evidence of bc in any anatomic site \[other than the three sites mentioned above\]) that has either been histologically confirmed or clinically/radiographically diagnosed as recurrent invasive bc; Death attributable to any cause, including bc, non-bc, or unknown cause. 3-year IDFS event-free rate per randomized treatment arms in the ITT population was estimated using the Kaplan-Meier method and estimated the probability of a participant being event-free after 3 years after randomization.
Time frame: Last participant randomized to data cut-off date of 27 November 2019 (approximately 70 months). The 3 year IDFS event-free rate was assessed based on the data collected for each participant considering the cut-off date mentioned above.
Invasive Disease-Free Survival (IDFS) in the Overall Population
IDFS event was defined as the time from randomization until the date of first occurrence of one of the following: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer \[bc\] involving the same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive bc recurrence (an invasive bc in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); Contralateral or ipsilateral second primary invasive bc; Distant recurrence (evidence of bc in any anatomic site \[other than the three sites mentioned above\]) that has either been histologically confirmed or clinically/radiographically diagnosed as recurrent invasive bc; Death attributable to any cause, including bc, non-bc, or unknown cause. 3-year IDFS event-free rate per randomized treatment arms in the ITT population were estimated using the Kaplan-Meier method and estimated the probability of a patient being event-free after 3 years after randomization.
Time frame: First participant randomized up to approximately 7.5 years
IDFS Plus Second Primary Non-Breast Cancer
IDFS including second primary non-breast cancer was defined the same way as IDFS for the primary endpoint but including second primary non breast invasive cancer as an event (with the exception of non-melanoma skin cancers and carcinoma in situ (CIS) of any site).
Time frame: Baseline up to approximately 70 months
Disease-Free Survival (DFS)
DFS was defined as time between randomization and first occurrence of IDFS, second primary non-breast cancer and contralateral or ipsilateral ductal carcinoma in situ (DCIS).
Time frame: Baseline up to approximately 70 months
Distant Recurrence-Free Interval (DRFI)
DRFI was defined as time between randomization and first occurrence of distant breast cancer recurrence.
Time frame: Baseline up to approximately 70 months
Overall Survival (OS)
OS was defined as the time from randomization to death due to any cause.
Time frame: First participant randomized up to approximately 7.5 years
Percentage of Participants With Adverse Events
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs were reported based on the national cancer institute common terminology criteria for AEs, Version 4.0 (NCI-CTCAE, v4.0).
Time frame: From randomization to approximately 7.5 years
Percentage of Participants With Decrease in Left Ventricular Ejection Fraction (LVEF) From Baseline Over Time
LVEF was assessed using either echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scans.
Time frame: First participant randomized up to approximately 7.5 years.
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score
The EORTC QLQ-C30 included global health status, functional scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea/vomiting, and pain) and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Most questions used a 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale \[1 'very poor' to 7 'Excellent'\]). Scores were averaged and transformed to 0 - 100 scale, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 7 - 15 points considered to be a clinically meaningful detioration to participants. A positive value means an increase, while a negative value means a decrease, in score at the indicated time-point relative to the score at baseline (Cycle 1, Day 1).
Time frame: Baseline, Cycles 1, 2, 3, 4, 5, 9, 14, End of Treatment, Follow-up Month 6, Follow-up Month 12, Follow-up Month 18
EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score
EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30. There are four functional scales (body image, sexual enjoyment, sexual functioning, future perspective \[FP\]) and four symptom scales (systemic side effects \[SE\], upset by hair loss, arm symptoms, breast symptoms). Questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Scores averaged and transformed to 0-100 scale. High score for functional scale indicated high/better level of functioning/healthy functioning. Higher scores for symptom scales represent higher levels of symptoms/problems. For functional scales, positive change from baseline indicated improvement in quality of life (QOL) while negative change from baseline indicated a deterioration. For symptom scales, positive change from baseline indicated deterioration and negative change indicated improvement.
Time frame: Baseline, Cycles 1, 2, 3, 4, 5, 9, 14, End of Treatment, Follow-up Month 6, Follow-up Month 12, Follow-up Month 18
Time to Clinically Meaningful Deterioration in the Global Health Status/ Quality of Life and Functional (Physical, Role, and Cognitive) Subscales of the QLQ-C30 From First HER2-Targeted Treatment
The time to clinically meaningful deterioration in the global health status/Quality of life and Functional (Physical, Role, and Cognitive) subscales of the the QLQ-C30 was assessed from the time of the HER2-Targeted treatment to the worsening in the respective scales. Clinically meaningful deterioration is defined as a decrease in score of 10 points in Physical functioning and HRQoL; decrease of 7 points in Cognitive functioning, and decrease of 14 points in Role functioning.
Time frame: From start of HER-2 targeted treatment up to 18 months after treatment discontinuation. The median time to clinically meaningful deterioration was assessed based on the data collection described above.
The study was conducted at 288 centers in 36 countries.
| Milestone | Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab |
|---|---|---|
| Started | 918 | 928 |
| Completed | 0 | 0 |
| Not completed | 918 | 928 |
| Withdrew: Death | 44 | 56 |
| Withdrew: Lost to follow-up | 46 | 39 |
| Withdrew: Various reasons | 4 | 4 |
| Withdrew: Physician decision | 7 | 5 |
| Withdrew: Study terminated by sponsor | 758 | 773 |
| Withdrew: Withdrawal by subject | 59 | 51 |
IDFS event was defined as the time from randomization until the date of first occurrence of one of the following: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer \[bc\] involving the same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive bc recurrence (an invasive bc in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); Contralateral or ipsilateral second primary invasive bc; Distant recurrence (evidence of bc in any anatomic site \[other than the three sites mentioned above\]) that has either been histologically confirmed or clinically/radiographically diagnosed as recurrent invasive bc; Death attributable to any cause, including bc, non-bc, or unknown cause. 3-year IDFS event-free rate per randomized treatment arms in the ITT population was estimated using the Kaplan-Meier method and estimated the probability of a participant being event-free after 3 years after randomization.
| Percent Probability | Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab |
|---|---|---|
| Invasive Disease-Free Survival (IDFS) in the Node-Positive Subpopulation | 94.10 (92.46 to 95.73) | 92.75 (90.95 to 94.54) |
IDFS event was defined as the time from randomization until the date of first occurrence of one of the following: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer \[bc\] involving the same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive bc recurrence (an invasive bc in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); Contralateral or ipsilateral second primary invasive bc; Distant recurrence (evidence of bc in any anatomic site \[other than the three sites mentioned above\]) that has either been histologically confirmed or clinically/radiographically diagnosed as recurrent invasive bc; Death attributable to any cause, including bc, non-bc, or unknown cause. 3-year IDFS event-free rate per randomized treatment arms in the ITT population were estimated using the Kaplan-Meier method and estimated the probability of a patient being event-free after 3 years after randomization.
| Percent Probability | Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab |
|---|---|---|
| Invasive Disease-Free Survival (IDFS) in the Overall Population | 94.22 (92.68 to 95.76) | 93.06 (91.40 to 94.73) |
IDFS including second primary non-breast cancer was defined the same way as IDFS for the primary endpoint but including second primary non breast invasive cancer as an event (with the exception of non-melanoma skin cancers and carcinoma in situ (CIS) of any site).
| Percent Probability | Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab |
|---|---|---|
| IDFS Plus Second Primary Non-Breast Cancer | 93.43 (91.79 to 95.06) | 92.26 (90.51 to 94.02) |
DFS was defined as time between randomization and first occurrence of IDFS, second primary non-breast cancer and contralateral or ipsilateral ductal carcinoma in situ (DCIS).
| Percent Probability | Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab |
|---|---|---|
| Disease-Free Survival (DFS) | 93.32 (91.67 to 94.97) | 92.04 (90.26 to 93.81) |
DRFI was defined as time between randomization and first occurrence of distant breast cancer recurrence.
| Percent Probability | Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab |
|---|---|---|
| Distant Recurrence-Free Interval (DRFI) | 95.23 (93.82 to 96.64) | 94.91 (93.46 to 96.36) |
OS was defined as the time from randomization to death due to any cause.
| Percent Probability | Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab |
|---|---|---|
| Overall Survival (OS) | 96.03 (94.72 to 97.34) | 94.86 (93.40 to 96.32) |
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs were reported based on the national cancer institute common terminology criteria for AEs, Version 4.0 (NCI-CTCAE, v4.0).
| Percentage of participants | Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab |
|---|---|---|
| Percentage of Participants With Adverse Events | 98.5 | 99.1 |
LVEF was assessed using either echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scans.
| Participants | Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab |
|---|---|---|
| Decrease from baseline <10 Ejection Fraction (EF) points | 506 | 522 |
| Absolute value >= 50% and decrease from baseline >= 10 EF points | 254 | 245 |
| Absolute value < 50% and decrease from baseline >= 10 EF points | 71 | 35 |
| Absolute value < 50% and decrease from baseline >= 15 EF points | 61 | 28 |
The EORTC QLQ-C30 included global health status, functional scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea/vomiting, and pain) and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Most questions used a 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale \[1 'very poor' to 7 'Excellent'\]). Scores were averaged and transformed to 0 - 100 scale, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 7 - 15 points considered to be a clinically meaningful detioration to participants. A positive value means an increase, while a negative value means a decrease, in score at the indicated time-point relative to the score at baseline (Cycle 1, Day 1).
| Units on a Scale | Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab |
|---|---|---|
| Baseline: Appetite Loss | 8.2 ± 17.6 | 7.6 ± 16.8 |
| Change at Cycle 1: Appetite Loss | 12.2 ± 27.9 | 10.8 ± 26.6 |
| Change at Cycle 2: Appetite Loss | 15.2 ± 27.7 | 13.1 ± 26.7 |
| Change at Cycle 3: Appetite Loss | 14.3 ± 28.2 | 10.3 ± 25.7 |
| Change at Cycle 4: Appetite Loss | 16.2 ± 29.8 | 9.4 ± 25.5 |
| Change at Cycle 5: Appetite Loss | 12.0 ± 28.4 | 9.0 ± 26.2 |
| Change at Cycle 9: Appetite Loss | 5.7 ± 23.9 | 8.2 ± 25.7 |
| Change at Cycle 14: Appetite Loss | 2.2 ± 23.1 | 6.4 ± 25.4 |
| Change at EoT: Appetite Loss | 0.5 ± 22.3 | 5.6 ± 25.1 |
| Change at FU Month 6: Appetite Loss | -1.3 ± 20.7 | -2.4 ± 20.3 |
| Change at FU Month 12: Appetite Loss | -2.2 ± 20.8 | -2.3 ± 20.5 |
| Change at FU Month 18: Appetite Loss | — | -16.7 ± 23.6 |
| Baseline: Constipation | 9.6 ± 19.4 | 9.0 ± 19.6 |
| Change at Cycle 1: Constipation | 8.4 ± 22.5 | 8.0 ± 26.1 |
| Change at Cycle 2: Constipation | 1.1 ± 25.0 | 0.9 ± 23.1 |
| Change at Cycle 3: Constipation | 2.0 ± 24.6 | 0.2 ± 22.2 |
| Change at Cycle 4: Constipation | 2.5 ± 24.3 | -0.6 ± 23.2 |
| Change at Cycle 5: Constipation | 0.5 ± 22.4 | -0.4 ± 22.1 |
| Change at Cycle 9: Constipation | -0.7 ± 21.7 | 3.3 ± 24.7 |
| Change at Cycle 14: Constipation | 0.6 ± 21.1 | 4.2 ± 24.6 |
| Change at EoT: Constipation | 0.2 ± 21.8 | 4.7 ± 25.1 |
| Change at FU Month 6: Constipation | 3.4 ± 23.2 | 1.5 ± 24.1 |
| Change at FU Month 12: Constipation | 2.8 ± 22.8 | 2.0 ± 23.3 |
| Change at FU Month 18: Constipation | — | 0.0 ± 0.0 |
| Baseline: Diarrhea | 5.2 ± 13.2 | 4.7 ± 12.9 |
| Change at Cycle 1: Diarrhea | 4.7 ± 20.3 | 4.2 ± 18.4 |
| Change at Cycle 2: Diarrhea | 32.5 ± 32.8 | 16.0 ± 26.9 |
| Change at Cycle 3: Diarrhea | 28.4 ± 30.5 | 11.3 ± 23.5 |
| Change at Cycle 4: Diarrhea | 26.5 ± 30.0 | 10.3 ± 23.6 |
| Change at Cycle 5: Diarrhea | 23.9 ± 30.4 | 8.8 ± 22.8 |
| Change at Cycle 9: Diarrhea | 12.6 ± 24.6 | 4.7 ± 21.7 |
| Change at Cycle 14: Diarrhea | 12.5 ± 26.4 | 5.1 ± 20.3 |
| Change at EoT: Diarrhea | 10.3 ± 25.2 | 3.0 ± 19.4 |
| Change at FU Month 6: Diarrhea | -0.3 ± 16.4 | -1.1 ± 16.3 |
| Change at FU Month 12: Diarrhea | -0.3 ± 17.8 | 0.0 ± 17.1 |
| Change at FU Month 18: Diarrhea | — | -16.7 ± 23.6 |
| Baseline: Dyspnea | 5.8 ± 14.0 | 6.2 ± 14.3 |
| Change at Cycle 1: Dyspnea | 10.4 ± 21.4 | 9.2 ± 21.8 |
| Change at Cycle 2: Dyspnea | 11.6 ± 22.0 | 7.4 ± 20.6 |
| Change at Cycle 3: Dyspnea | 13.4 ± 23.2 | 6.5 ± 20.5 |
| Change at Cycle 4: Dyspnea | 14.3 ± 23.7 | 5.9 ± 20.8 |
| Change at Cycle 5: Dyspnea | 13.7 ± 22.4 | 5.6 ± 19.8 |
| Change at Cycle 9: Dyspnea | 7.8 ± 19.3 | 7.5 ± 21.4 |
| Change at Cycle 14: Dyspnea | 6.8 ± 20.8 | 8.1 ± 21.6 |
| Change at EoT: Dyspnea | 7.6 ± 21.1 | 8.8 ± 22.3 |
| Change at FU Month 6: Dyspnea | 7.0 ± 20.8 | 5.3 ± 19.7 |
| Change at FU Month 12: Dyspnea | 6.2 ± 20.9 | 5.8 ± 20.5 |
| Change at FU Month 18: Dyspnea | — | -16.7 ± 23.6 |
| Baseline: Fatigue | 21.5 ± 18.6 | 20.6 ± 18.6 |
| Change at Cycle 1: Fatigue | 13.2 ± 21.5 | 14.4 ± 22.1 |
| Change at Cycle 2: Fatigue | 15.4 ± 22.7 | 11.2 ± 21.7 |
| Change at Cycle 3: Fatigue | 15.3 ± 23.1 | 8.7 ± 20.9 |
| Change at Cycle 4: Fatigue | 16.0 ± 23.4 | 8.2 ± 20.7 |
| Change at Cycle 5: Fatigue | 14.9 ± 22.8 | 8.4 ± 21.1 |
| Change at Cycle 9: Fatigue | 8.4 ± 22.0 | 9.8 ± 20.8 |
| Change at Cycle 14: Fatigue | 6.7 ± 22.0 | 10.6 ± 22.4 |
| Change at EoT: Fatigue | 5.5 ± 22.9 | 9.3 ± 21.9 |
| Change at FU Month 6: Fatigue | 2.8 ± 21.9 | 3.1 ± 21.9 |
| Change at FU Month 12: Fatigue | 1.9 ± 22.1 | 1.8 ± 20.8 |
| Change at FU Month 18: Fatigue | — | -5.6 ± 39.3 |
| Baseline: Financial Difficulties | 20.1 ± 28.3 | 19.9 ± 28.5 |
| Change at Cycle 1: Financial Difficulties | 2.2 ± 25.2 | 0.3 ± 24.8 |
| Change at Cycle 2: Financial Difficulties | 2.0 ± 25.7 | -0.6 ± 25.3 |
| Change at Cycle 3: Financial Difficulties | 3.9 ± 24.7 | -0.4 ± 25.0 |
| Change at Cycle 4: Financial Difficulties | 3.7 ± 24.9 | -0.2 ± 25.4 |
| Change at Cycle 5: Financial Difficulties | 3.4 ± 25.3 | 0.7 ± 26.2 |
| Change at Cycle 9: Financial Difficulties | 0.9 ± 25.6 | -0.5 ± 26.6 |
| Change at Cycle 14: Financial Difficulties | -1.4 ± 25.1 | -1.0 ± 27.2 |
| Change at EoT: Financial Difficulties | -1.1 ± 27.3 | -1.7 ± 25.7 |
| Change at FU Month 6: Financial Difficulties | -3.8 ± 27.4 | -5.2 ± 28.7 |
| Change at FU Month 12: Financial Difficulties | -5.1 ± 28.6 | -6.8 ± 28.3 |
| Change at FU Month 18: Financial Difficulties | — | 0.0 ± 0.0 |
| Baseline: Insomnia | 23.9 ± 26.1 | 24.9 ± 27.6 |
| Change at Cycle 1: Insomnia | 3.6 ± 30.2 | 1.8 ± 28.8 |
| Change at Cycle 2: Insomnia | 6.0 ± 30.5 | 0.4 ± 30.0 |
| Change at Cycle 3: Insomnia | 6.2 ± 30.2 | -0.1 ± 30.3 |
| Change at Cycle 4: Insomnia | 8.6 ± 31.3 | 1.1 ± 30.4 |
| Change at Cycle 5: Insomnia | 5.2 ± 31.1 | 1.1 ± 29.9 |
| Change at Cycle 9: Insomnia | 4.3 ± 30.5 | 1.1 ± 29.9 |
| Change at Cycle 14: Insomnia | 2.7 ± 30.6 | 2.7 ± 30.2 |
| Change at EoT: Insomnia | 2.5 ± 30.8 | 0.9 ± 30.2 |
| Change at FU Month 6: Insomnia | 0.9 ± 29.5 | -2.3 ± 29.6 |
| Change at FU Month 12: Insomnia | 0.0 ± 30.2 | -2.9 ± 30.4 |
| Change at FU Month 18: Insomnia | — | -16.7 ± 23.6 |
| Baseline: Nausea/Vomiting | 2.6 ± 9.4 | 2.3 ± 7.1 |
| Change at Cycle 1: Nausea/Vomiting | 10.4 ± 19.5 | 10.5 ± 17.8 |
| Change at Cycle 2: Nausea/Vomiting | 6.0 ± 16.5 | 7.5 ± 16.1 |
| Change at Cycle 3: Nausea/Vomiting | 5.0 ± 16.2 | 5.2 ± 13.9 |
| Change at Cycle 4: Nausea/Vomiting | 4.7 ± 16.0 | 3.7 ± 12.8 |
| Change at Cycle 5: Nausea/Vomiting | 4.0 ± 15.6 | 3.2 ± 13.1 |
| Change at Cycle 9: Nausea/Vomiting | 1.1 ± 13.8 | 2.8 ± 11.5 |
| Change at Cycle 14: Nausea/Vomiting | 1.1 ± 12.3 | 3.0 ± 12.1 |
| Change at EoT: Nausea/Vomiting | 0.9 ± 13.2 | 1.7 ± 12.0 |
| Change at FU Month 6: Nausea/Vomiting | 0.2 ± 11.6 | 0.1 ± 10.1 |
| Change at FU Month 12: Nausea/Vomiting | 0.5 ± 12.4 | 0.6 ± 10.3 |
| Change at FU Month 18: Nausea/Vomiting | — | -8.3 ± 11.8 |
| Baseline: Pain | 17.4 ± 20.1 | 16.4 ± 20.0 |
| Change at Cycle 1: Pain | 1.8 ± 22.8 | 1.1 ± 22.5 |
| Change at Cycle 2: Pain | 5.0 ± 24.5 | 2.8 ± 23.1 |
| Change at Cycle 3: Pain | 3.5 ± 23.7 | 2.5 ± 22.6 |
| Change at Cycle 4: Pain | 5.4 ± 23.2 | 3.1 ± 23.5 |
| Change at Cycle 5: Pain | 5.2 ± 23.7 | 3.8 ± 23.5 |
| Change at Cycle 9: Pain | 3.4 ± 22.6 | 3.9 ± 23.3 |
| Change at Cycle 14: Pain | 2.0 ± 23.4 | 5.7 ± 24.1 |
| Change at EoT: Pain | 1.9 ± 23.3 | 5.1 ± 24.5 |
| Change at FU Month 6: Pain | 0.8 ± 23.0 | 1.4 ± 22.6 |
| Change at FU Month 12: Pain | 0.0 ± 23.3 | 0.5 ± 21.5 |
| Change at FU Month 18: Pain | — | -25.0 ± 35.4 |
| Baseline: Cognitive Functioning | 88.6 ± 16.9 | 88.7 ± 16.3 |
| Change at Cycle 1: Cognitive Functioning | -9.7 ± 20.8 | -6.9 ± 19.3 |
| Change at Cycle 2: Cognitive Functioning | -9.4 ± 20.0 | -6.8 ± 19.3 |
| Change at Cycle 3: Cognitive Functioning | -10.1 ± 20.8 | -6.4 ± 19.4 |
| Change at Cycle 4: Cognitive Functioning | -11.8 ± 21.6 | -6.9 ± 19.6 |
| Change at Cycle 5: Cognitive Functioning | -10.8 ± 21.6 | -7.3 ± 20.3 |
| Change at Cycle 9: Cognitive Functioning | -8.3 ± 20.2 | -7.6 ± 20.1 |
| Change at Cycle 14: Cognitive Functioning | -8.1 ± 20.3 | -8.1 ± 20.6 |
| Change at EoT: Cognitive Functioning | -8.7 ± 22.3 | -8.4 ± 20.9 |
| Change at FU Month 6: Cognitive Functioning | -8.0 ± 20.4 | -6.1 ± 19.7 |
| Change at FU Month 12: Cognitive Functioning | -7.1 ± 22.5 | -6.0 ± 20.7 |
| Change at FU Month 18: Cognitive Functioning | — | 16.7 ± 23.6 |
| Baseline: Emotional Functioning | 76.0 ± 19.7 | 75.7 ± 20.9 |
| Change at Cycle 1: Emotional Functioning | -1.1 ± 20.3 | 0.0 ± 19.2 |
| Change at Cycle 2: Emotional Functioning | -1.0 ± 20.8 | 1.6 ± 19.7 |
| Change at Cycle 3: Emotional Functioning | -0.9 ± 21.2 | 2.2 ± 19.6 |
| Change at Cycle 4: Emotional Functioning | -2.5 ± 22.3 | 2.8 ± 20.0 |
| Change at Cycle 5: Emotional Functioning | -1.2 ± 22.2 | 2.6 ± 21.1 |
| Change at Cycle 9: Emotional Functioning | 3.1 ± 20.9 | 2.9 ± 21.1 |
| Change at Cycle 14: Emotional Functioning | 4.1 ± 21.0 | 2.5 ± 21.3 |
| Change at EoT: Emotional Functioning | 3.0 ± 22.4 | 3.1 ± 21.3 |
| Change at FU Month 6: Emotional Functioning | 4.7 ± 21.2 | 6.1 ± 21.8 |
| Change at FU Month 12: Emotional Functioning | 5.8 ± 22.1 | 6.5 ± 21.9 |
| Change at FU Month 18: Emotional Functioning | — | 12.5 ± 17.7 |
| Baseline: Physical Functioning | 88.4 ± 13.5 | 89.1 ± 12.3 |
| Change at Cycle 1: Physical Functioning | -6.0 ± 14.5 | -5.9 ± 13.4 |
| Change at Cycle 2: Physical Functioning | -7.8 ± 15.8 | -4.8 ± 12.8 |
| Change at Cycle 3: Physical Functioning | -7.1 ± 15.4 | -4.1 ± 13.0 |
| Change at Cycle 4: Physical Functioning | -8.4 ± 16.2 | -3.5 ± 13.1 |
| Change at Cycle 5: Physical Functioning | -8.3 ± 16.1 | -3.5 ± 13.3 |
| Change at Cycle 9: Physical Functioning | -4.0 ± 15.0 | -3.8 ± 14.2 |
| Change at Cycle 14: Physical Functioning | -2.7 ± 14.2 | -4.2 ± 14.2 |
| Change at EoT: Physical Functioning | -2.2 ± 14.7 | -4.9 ± 15.0 |
| Change at FU Month 6: Physical Functioning | -0.6 ± 14.4 | -1.6 ± 13.6 |
| Change at FU Month 12: Physical Functioning | -0.1 ± 15.4 | -0.8 ± 13.2 |
| Change at FU Month 18: Physical Functioning | — | 13.3 ± 18.9 |
| Baseline: Role Functioning | 83.1 ± 21.7 | 83.4 ± 21.3 |
| Change at Cycle 1: Role Functioning | -5.1 ± 24.5 | -5.7 ± 24.9 |
| Change at Cycle 2: Role Functioning | -9.7 ± 26.6 | -5.5 ± 24.0 |
| Change at Cycle 3: Role Functioning | -8.9 ± 26.7 | -2.7 ± 23.2 |
| Change at Cycle 4: Role Functioning | -10.7 ± 27.5 | -3.2 ± 23.7 |
| Change at Cycle 5: Role Functioning | -9.4 ± 27.3 | -3.5 ± 23.9 |
| Change at Cycle 9: Role Functioning | -3.3 ± 25.4 | -3.2 ± 24.1 |
| Change at Cycle 14: Role Functioning | -0.5 ± 25.0 | -4.3 ± 25.3 |
| Change at EoT: Role Functioning | -0.2 ± 26.3 | -3.5 ± 24.9 |
| Change at FU Month 6: Role Functioning | 2.2 ± 24.7 | 2.4 ± 24.1 |
| Change at FU Month 12: Role Functioning | 2.6 ± 25.9 | 3.7 ± 23.8 |
| Change at FU Month 18: Role Functioning | — | 8.3 ± 11.8 |
| Baseline: Social Functioning | 83.0 ± 22.9 | 83.2 ± 21.6 |
| Change at Cycle 1: Social Functioning | -8.0 ± 24.3 | -5.3 ± 22.8 |
| Change at Cycle 2: Social Functioning | -10.1 ± 26.1 | -4.1 ± 23.6 |
| Change at Cycle 3: Social Functioning | -9.5 ± 25.6 | -3.3 ± 24.4 |
| Change at Cycle 4: Social Functioning | -10.3 ± 26.3 | -3.2 ± 24.2 |
| Change at Cycle 5: Social Functioning | -8.7 ± 26.5 | -2.6 ± 23.7 |
| Change at Cycle 9: Social Functioning | -1.7 ± 25.1 | -3.4 ± 24.9 |
| Change at Cycle 14: Social Functioning | -0.1 ± 25.3 | -2.4 ± 24.9 |
| Change at EoT: Social Functioning | 0.3 ± 26.1 | -1.6 ± 24.1 |
| Change at FU Month 6: Social Functioning | 3.3 ± 24.8 | 4.0 ± 24.7 |
| Change at FU Month 12: Social Functioning | 4.6 ± 25.2 | 6.4 ± 22.7 |
| Change at FU Month 18: Social Functioning | — | 33.3 ± 47.1 |
| Baseline: Global Health Status | 74.3 ± 18.7 | 73.9 ± 18.7 |
| Change at Cycle 1: Global Health Status | -7.5 ± 20.1 | -7.2 ± 20.4 |
| Change at Cycle 2: Global Health Status | -12.4 ± 22.6 | -7.1 ± 20.2 |
| Change at Cycle 3: Global Health Status | -11.7 ± 20.6 | -5.2 ± 19.1 |
| Change at Cycle 4: Global Health Status | -12.7 ± 21.3 | -5.5 ± 19.6 |
| Change at Cycle 5: Global Health Status | -12.1 ± 21.7 | -5.8 ± 19.7 |
| Change at Cycle 9: Global Health Status | -5.9 ± 20.1 | -6.4 ± 20.6 |
| Change at Cycle 14: Global Health Status | -3.9 ± 21.1 | -6.3 ± 20.8 |
| Change at EoT: Global Health Status | -3.5 ± 21.3 | -4.9 ± 20.7 |
| Change at FU Month 6: Global Health Status | -0.6 ± 21.3 | 0.3 ± 21.4 |
| Change at FU Month 12: Global Health Status | -0.2 ± 21.9 | 1.2 ± 20.8 |
| Change at FU Month 18: Global Health Status | — | 16.7 ± 23.6 |
EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30. There are four functional scales (body image, sexual enjoyment, sexual functioning, future perspective \[FP\]) and four symptom scales (systemic side effects \[SE\], upset by hair loss, arm symptoms, breast symptoms). Questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Scores averaged and transformed to 0-100 scale. High score for functional scale indicated high/better level of functioning/healthy functioning. Higher scores for symptom scales represent higher levels of symptoms/problems. For functional scales, positive change from baseline indicated improvement in quality of life (QOL) while negative change from baseline indicated a deterioration. For symptom scales, positive change from baseline indicated deterioration and negative change indicated improvement.
| Units on a Scale | Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab |
|---|---|---|
| Baseline: Arm Symptoms | 19.9 ± 18.7 | 19.5 ± 18.4 |
| Change at Cycle 1: Arm Symptoms | -1.3 ± 19.2 | -3.1 ± 18.7 |
| Change at Cycle 2: Arm Symptoms | -2.8 ± 18.8 | -3.0 ± 18.7 |
| Change at Cycle 3: Arm Symptoms | -3.5 ± 18.7 | -3.5 ± 18.1 |
| Change at Cycle 4: Arm Symptoms | -2.0 ± 19.8 | -2.9 ± 19.2 |
| Change at Cycle 5: Arm Symptoms | -0.5 ± 20.8 | -2.6 ± 19.8 |
| Change at Cycle 9: Arm Symptoms | -0.2 ± 20.4 | -1.1 ± 19.6 |
| Change at Cycle 14: Arm Symptoms | 0.3 ± 21.3 | 1.3 ± 21.8 |
| Change at EoT: Arm Symptoms | 0.1 ± 21.6 | 0.4 ± 21.7 |
| Change at FU Month 6: Arm Symptoms | -0.1 ± 22.1 | -1.3 ± 20.0 |
| Change at FU Month 12: Arm Symptoms | -0.8 ± 22.4 | -2.8 ± 20.5 |
| Baseline: Breast Symptoms | 17.5 ± 17.4 | 16.8 ± 16.3 |
| Change at Cycle 1: Breast Symptoms | -2.3 ± 16.3 | -2.5 ± 16.2 |
| Change at Cycle 2: Breast Symptoms | -3.3 ± 17.1 | -2.9 ± 16.7 |
| Change at Cycle 3: Breast Symptoms | -4.0 ± 17.5 | -3.1 ± 16.5 |
| Change at Cycle 4: Breast Symptoms | -3.9 ± 17.7 | -3.3 ± 17.4 |
| Change at Cycle 5: Breast Symptoms | -3.1 ± 18.6 | -2.6 ± 18.2 |
| Change at Cycle 9: Breast Symptoms | 1.7 ± 19.7 | 0.3 ± 17.5 |
| Change at Cycle 14: Breast Symptoms | -0.2 ± 18.8 | 0.5 ± 19.1 |
| Change at EoT: Breast Symptoms | -1.0 ± 19.3 | 0.3 ± 18.8 |
| Change at FU Month 6: Breast Symptoms | -2.5 ± 19.1 | -1.5 ± 18.4 |
| Change at FU Month 12: Breast Symptoms | -4.2 ± 18.9 | -3.7 ± 18.0 |
| Baseline: Systemic Therapy Side Effects (SE) | 8.5 ± 9.9 | 8.7 ± 9.9 |
| Change at Cycle 1: Systemic Therapy SE | 24.9 ± 17.3 | 23.3 ± 17.6 |
| Change at Cycle 2: Systemic Therapy SE | 24.1 ± 18.1 | 18.3 ± 16.6 |
| Change at Cycle 3: Systemic Therapy SE | 23.4 ± 17.8 | 15.1 ± 15.5 |
| Change at Cycle 4: Systemic Therapy SE | 23.1 ± 18.1 | 13.2 ± 15.4 |
| Change at Cycle 5: Systemic Therapy SE | 20.0 ± 17.6 | 11.8 ± 14.7 |
| Change at Cycle 9: Systemic Therapy SE | 9.5 ± 13.1 | 10.4 ± 14.0 |
| Change at Cycle 14: Systemic Therapy SE | 7.5 ± 12.9 | 9.8 ± 13.9 |
| Change at EoT: Systemic Therapy SE | 7.2 ± 13.4 | 8.5 ± 13.9 |
| Change at FU Month 6: Systemic Therapy SE | 5.8 ± 12.3 | 4.2 ± 12.5 |
| Change at FU Month 12: Systemic Therapy SE | 5.4 ± 12.9 | 4.2 ± 13.0 |
| Baseline: Upset by Hair Loss Item | 13.2 ± 23.7 | 14.2 ± 22.9 |
| Change at Cycle 1: Upset by Hair Loss Item | 35.1 ± 37.3 | 25.2 ± 35.1 |
| Change at Cycle 2: Upset by Hair Loss Item | 28.7 ± 36.0 | 21.8 ± 36.6 |
| Change at Cycle 3: Upset by Hair Loss Item | 28.8 ± 36.3 | 21.4 ± 38.4 |
| Change at Cycle 4: Upset by Hair Loss Item | 28.4 ± 37.1 | 19.7 ± 34.2 |
| Change at Cycle 5: Upset by Hair Loss Item | 26.4 ± 36.8 | 10.0 ± 36.3 |
| Change at Cycle 9: Upset by Hair Loss Item | 11.8 ± 33.6 | 6.0 ± 36.8 |
| Change at Cycle 14: Upset by Hair Loss Item | 9.3 ± 32.5 | 2.5 ± 26.0 |
| Change at EoT: Upset by Hair Loss Item | 17.3 ± 33.9 | 0.0 ± 28.1 |
| Change at FU Month 6: Upset by Hair Loss Item | 6.2 ± 26.8 | -3.5 ± 21.0 |
| Change at FU Month 12: Upset by Hair Loss Item | 2.4 ± 28.7 | -2.8 ± 29.7 |
| Baseline: Body Image | 78.5 ± 23.2 | 78.9 ± 24.2 |
| Change at Cycle 1: Body Image | -13.7 ± 23.5 | -13.3 ± 23.1 |
| Change at Cycle 2: Body Image | -12.7 ± 23.9 | -10.1 ± 23.9 |
| Change at Cycle 3: Body Image | -11.5 ± 24.8 | -6.6 ± 22.6 |
| Change at Cycle 4: Body Image | -11.4 ± 24.8 | -5.9 ± 23.2 |
| Change at Cycle 5: Body Image | -10.5 ± 24.6 | -5.0 ± 22.6 |
| Change at Cycle 9: Body Image | -5.9 ± 22.8 | -4.2 ± 21.7 |
| Change at Cycle 14: Body Image | -4.5 ± 23.6 | -2.4 ± 23.2 |
| Change at EoT: Body Image | -3.3 ± 23.1 | -2.9 ± 22.8 |
| Change at FU Month 6: Body Image | -1.3 ± 23.4 | 0.3 ± 23.3 |
| Change at FU Month 12: Body Image | 0.0 ± 24.2 | 0.7 ± 23.5 |
| Baseline: Future Perspectives (FP) | 49.3 ± 31.4 | 49.8 ± 30.9 |
| Change at Cycle 1: FP | -1.3 ± 30.3 | -0.3 ± 31.1 |
| Change at Cycle 2: FP | 1.4 ± 31.7 | 3.7 ± 30.4 |
| Change at Cycle 3: FP | 3.2 ± 32.0 | 6.5 ± 30.1 |
| Change at Cycle 4: FP | 4.2 ± 31.7 | 7.8 ± 30.5 |
| Change at Cycle 5: FP | 5.9 ± 32.4 | 9.7 ± 30.7 |
| Change at Cycle 9: FP | 8.2 ± 32.2 | 8.4 ± 31.3 |
| Change at Cycle 14: FP | 9.5 ± 32.0 | 7.9 ± 33.4 |
| Change at EoT: FP | 8.5 ± 32.6 | 7.6 ± 32.3 |
| Change at FU Month 6: FP | 10.5 ± 31.3 | 12.6 ± 32.6 |
| Change at FU Month 12: FP | 15.0 ± 34.0 | 13.1 ± 33.2 |
| Baseline: Sexual Enjoyment | 43.4 ± 32.1 | 46.7 ± 34.8 |
| Change at Cycle 1: Sexual Enjoyment | -5.9 ± 26.8 | -8.2 ± 27.0 |
| Change at Cycle 2: Sexual Enjoyment | -9.5 ± 30.2 | -10.7 ± 29.2 |
| Change at Cycle 3: Sexual Enjoyment | -11.4 ± 26.8 | -8.9 ± 31.6 |
| Change at Cycle 4: Sexual Enjoyment | -11.9 ± 30.6 | -9.2 ± 28.3 |
| Change at Cycle 5: Sexual Enjoyment | -14.2 ± 28.1 | -8.8 ± 30.4 |
| Change at Cycle 9: Sexual Enjoyment | -9.4 ± 29.5 | -7.4 ± 30.9 |
| Change at Cycle 14: Sexual Enjoyment | -3.9 ± 28.6 | -9.7 ± 31.4 |
| Change at EoT: Sexual Enjoyment | -6.5 ± 29.2 | -9.7 ± 29.4 |
| Change at FU Month 6: Sexual Enjoyment | -4.6 ± 28.8 | -3.0 ± 30.5 |
| Change at FU Month 12: Sexual Enjoyment | -5.7 ± 30.9 | -2.3 ± 31.0 |
| Baseline: Sexual Function | 16.7 ± 22.3 | 18.3 ± 22.9 |
| Change at Cycle 1: Sexual Function | -2.3 ± 18.9 | -3.5 ± 18.4 |
| Change at Cycle 2: Sexual Function | -4.8 ± 19.9 | -4.4 ± 18.4 |
| Change at Cycle 3: Sexual Function | -5.6 ± 19.6 | -3.3 ± 19.0 |
| Change at Cycle 4: Sexual Function | -6.8 ± 19.7 | -3.4 ± 17.9 |
| Change at Cycle 5: Sexual Function | -5.9 ± 19.5 | -3.0 ± 19.5 |
| Change at Cycle 9: Sexual Function | -3.4 ± 19.3 | -1.8 ± 20.8 |
| Change at Cycle 14: Sexual Function | -1.8 ± 20.0 | -2.8 ± 20.6 |
| Change at EoT: Sexual Function | -1.5 ± 20.9 | -1.7 ± 19.7 |
| Change at FU Month 6: Sexual Function | 1.6 ± 22.6 | 0.6 ± 20.4 |
| Change at FU Month 12: Sexual Function | 0.9 ± 21.7 | 0.9 ± 20.9 |
The time to clinically meaningful deterioration in the global health status/Quality of life and Functional (Physical, Role, and Cognitive) subscales of the the QLQ-C30 was assessed from the time of the HER2-Targeted treatment to the worsening in the respective scales. Clinically meaningful deterioration is defined as a decrease in score of 10 points in Physical functioning and HRQoL; decrease of 7 points in Cognitive functioning, and decrease of 14 points in Role functioning.
| months | Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab |
|---|---|---|
| GHS/QoL Score | 2.73 (2.10 to 2.83) | 13.57 (9.20 to 21.91) |
| Physical Function | 25.53 (13.34 to NA) | NA (27.43 to NA) |
| Role Function | 2.23 (2.10 to 2.79) | 9.92 (9.00 to 14.36) |
| Cognitive Function | 5.49 (2.79 to 5.82) | 9.46 (8.57 to 12.91) |
Collected over From randomization to approximately 7.5 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | 45/926 (4.9%) | 216/926 (23.3%) | 902/926 (97.4%) |
| Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | 55/912 (6%) | 195/912 (21.4%) | 902/912 (98.9%) |
| Event | Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab |
|---|---|---|
| Febrile neutropeniaBlood and lymphatic system disorders | 51/926 | 31/912 |
| DiarrhoeaGastrointestinal disorders | 20/926 | 8/912 |
| PyrexiaGeneral disorders | 13/926 | 19/912 |
| NeutropeniaBlood and lymphatic system disorders | 16/926 | 10/912 |
| PneumoniaInfections and infestations | 12/926 | 12/912 |
| VomitingGastrointestinal disorders | 10/926 | 7/912 |
| NauseaGastrointestinal disorders | 6/926 | 9/912 |
| Infusion related reactionInjury, poisoning and procedural complications | 2/926 | 9/912 |
| Urinary tract infectionInfections and infestations | 6/926 | 8/912 |
| MastitisInfections and infestations | 8/926 | 0/912 |
| Event | Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab |
|---|---|---|
| AlopeciaSkin and subcutaneous tissue disorders | 629/926 | 598/912 |
| NauseaGastrointestinal disorders | 596/926 | 605/912 |
| DiarrhoeaGastrointestinal disorders | 605/926 | 405/912 |
| FatigueGeneral disorders | 439/926 | 419/912 |
| EpistaxisRespiratory, thoracic and mediastinal disorders | 182/926 | 333/912 |
| Aspartate aminotransferase increasedInvestigations | 98/926 | 317/912 |
| Alanine aminotransferase increasedInvestigations | 108/926 | 301/912 |
| ConstipationGastrointestinal disorders | 287/926 | 299/912 |
| VomitingGastrointestinal disorders | 243/926 | 289/912 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 289/926 | 261/912 |
Baseline Measures are based on the Intent-to-Treat (ITT) population.
| Age, Continuous(years) | Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | Total |
|---|---|---|---|
| Mean | 51.6 ± 10.8 | 51.9 ± 10.8 | 51.7 ± 10.8 |
| Sex: Female, Male(Participants) | Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | Total |
|---|---|---|---|
| Female | 913 | 926 | 1839 |
| Male | 5 | 2 | 7 |
| Ethnicity (NIH/OMB)(Participants) | Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | Total |
|---|---|---|---|
| Hispanic or Latino | 70 | 68 | 138 |
| Not Hispanic or Latino | 798 | 790 | 1588 |
| Unknown or Not Reported | 50 | 70 | 120 |
| Race (NIH/OMB)(Participants) | Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | Total |
|---|---|---|---|
| American Indian or Alaska Native | 12 | 12 | 24 |
| Asian | 267 | 275 | 542 |
| Native Hawaiian or Other Pacific Islander | 1 | 1 | 2 |
| Black or African American | 15 | 8 | 23 |
| White | 558 | 565 | 1123 |
| More than one race | 2 | 2 | 4 |
| Unknown or Not Reported | 63 | 65 | 128 |
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