A Phase 3 interventional study of trastuzumab and Chemotherapy in Breast Cancer, sponsored by Hoffmann-La Roche. Completed at 35 sites in Italy. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-10-24.
Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment
This 2 arm study will compare the efficacy and safety of continuation or discontinuation of Herceptin treatment in combination with 2nd line chemotherapy, in patients with HER2 positive metastatic breast cancer whose condition has progressed on 1st line chemotherapy plus Herceptin. Patients will be randomized either to continue or discontinue Herceptin treatment (2mg/kg iv infusion weekly, or 6mg/kg iv infusion every 3 weeks) while receiving 2nd line chemotherapy of the investigator's choice. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 58 is below 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:
Chemotherapy, schedule and dose at the investigator's discretion.
Drug: Chemotherapy
Trastuzumab, at the investigator's discretion, either 2 milligrams per kilogram (mg/kg) intravenous (i.v.) every 7 days or 6 mg/kg i.v. every 3 weeks. Chemotherapy, schedule and dose at the investigator's discretion.
Drug: trastuzumab · Drug: Chemotherapy
2mg/kg i.v. weekly, or 6mg/kg i.v. every 3 weeks
Also known as: Herceptin
Schedule and dose at the investigator's discretion
Progression-Free Survival (PFS) - Percentage of Participants With an Event
PFS was defined as the time from randomization to the date of documented disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or the date of occurrence of a second primary cancer, or date of death from any cause, whichever comes first. Participants were censored at the last tumour evaluation.
Time frame: Baseline (BL) and every 8 weeks thereafter
Progression-Free Survival - Time to Event
The median time from randomization to PFS event. Participants were censored at the last tumour evaluation.
Time frame: BL and every 8 weeks thereafter
Overall Survival (OS) - Percentage of Participants With an Event
OS was defined as the time from randomization to the date of death from any cause. Participants were censored at the last contact date at which the participant was known to be alive.
Time frame: BL and every 8 weeks thereafter
Overall Survival - Time to Event
The median time from randomization to OS event. Participants were censored at the last contact date at which the participant was known to be alive.
Time frame: BL and every 8 weeks thereafter
Percentage of Participants by Best Overall Response (BOR)
BOR was defined as the best objective response observed during the treatment period according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Complete response (CR): disappearance of all target lesions (TLs), with any pathological lymph nodes (whether target or non-target) having a reduction in short axis to less than 10 millimeters (mm). Partial response (PR): at least a 30 percent (%) decrease in the sum of diameters of TLs, taking as reference the BL sum diameters. Progressive disease (PD): at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that is the smallest on study). In addition to the relative increase in 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. Stable disease (SD) was defined as neither sufficient shrinkages to qualify for PR, nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Time frame: BL and every 8 weeks thereafter
Percentage of Participants With a Best Overall Response of CR or PR
BOR was defined as the best objective response observed during the treatment period according to RECIST version 1.1. CR: disappearance of all TLs, with any pathological lymph nodes (whether target or non-target) having a reduction in short axis to less than 10 mm. PR: at least a 30% decrease in the sum of diameters of TLs, taking as reference the BL sum diameters. PD: at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that is the smallest on study). In addition to the relative increase in 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. SD: neither sufficient shrinkages to qualify for PR, nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Time frame: BL and every 8 weeks thereafter
| Milestone | Chemotherapy Alone | Chemotherapy Plus (+) Trastuzumab |
|---|---|---|
| Started | 29 | 29 |
| Completed | 0 | 0 |
| Not completed | 29 | 29 |
| Withdrew: Lost to follow-up | 2 | 2 |
| Withdrew: Adverse event | 1 | 1 |
| Withdrew: Disease progression | 16 | 18 |
| Withdrew: Withdrawal by subject | 4 | 3 |
| Withdrew: Other | 6 | 4 |
| Withdrew: Protocol violation | 0 | 1 |
PFS was defined as the time from randomization to the date of documented disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or the date of occurrence of a second primary cancer, or date of death from any cause, whichever comes first. Participants were censored at the last tumour evaluation.
| percentage of participants | Chemotherapy Alone | Chemotherapy + Trastuzumab |
|---|---|---|
| Progression-Free Survival (PFS) - Percentage of Participants With an Event | 58.6 | 58.6 |
The median time from randomization to PFS event. Participants were censored at the last tumour evaluation.
| months | Chemotherapy Alone | Chemotherapy + Trastuzumab |
|---|---|---|
| Progression-Free Survival - Time to Event | 9.7 (5.5 to 18.9) | 9.4 (6.7 to 12.0) |
OS was defined as the time from randomization to the date of death from any cause. Participants were censored at the last contact date at which the participant was known to be alive.
| percentage of participants | Chemotherapy Alone | Chemotherapy + Trastuzumab |
|---|---|---|
| Overall Survival (OS) - Percentage of Participants With an Event | 55.2 | 34.5 |
The median time from randomization to OS event. Participants were censored at the last contact date at which the participant was known to be alive.
| months | Chemotherapy Alone | Chemotherapy + Trastuzumab |
|---|---|---|
| Overall Survival - Time to Event | 19.1 (17.0 to 32.7) | 26.7 (14.0 to NA) |
BOR was defined as the best objective response observed during the treatment period according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Complete response (CR): disappearance of all target lesions (TLs), with any pathological lymph nodes (whether target or non-target) having a reduction in short axis to less than 10 millimeters (mm). Partial response (PR): at least a 30 percent (%) decrease in the sum of diameters of TLs, taking as reference the BL sum diameters. Progressive disease (PD): at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that is the smallest on study). In addition to the relative increase in 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. Stable disease (SD) was defined as neither sufficient shrinkages to qualify for PR, nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
| percentage of participants | Chemotherapy Alone | Chemotherapy + Trastuzumab |
|---|---|---|
| CR | 0 | 10.3 |
| PR | 27.6 | 20.7 |
| SD | 24.1 | 24.1 |
| PD | 17.2 | 13.8 |
| Not Evaluated | 31.0 | 31.0 |
BOR was defined as the best objective response observed during the treatment period according to RECIST version 1.1. CR: disappearance of all TLs, with any pathological lymph nodes (whether target or non-target) having a reduction in short axis to less than 10 mm. PR: at least a 30% decrease in the sum of diameters of TLs, taking as reference the BL sum diameters. PD: at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that is the smallest on study). In addition to the relative increase in 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. SD: neither sufficient shrinkages to qualify for PR, nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
| percentage of participants | Chemotherapy Alone | Chemotherapy + Trastuzumab |
|---|---|---|
| Percentage of Participants With a Best Overall Response of CR or PR | 27.6 (12.7 to 47.2) | 31.0 (15.3 to 50.8) |
Collected over Adverse events (AEs) were recorded throughout the study. Drug-related serious AEs (SAEs) were collected, regardless of the time elapsed from last study treatment administration, even if the study had been closed.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Chemotherapy Alone | — | 4/26 (15.4%) | 26/26 (100%) |
| Chemotherapy + Trastuzumab | — | 1/28 (3.6%) | 26/28 (92.9%) |
| Event | Chemotherapy Alone | Chemotherapy + Trastuzumab |
|---|---|---|
| Febrile neutropeniaBlood and lymphatic system disorders | 1/26 | 0/28 |
| General MalaiseGeneral disorders | 1/26 | 0/28 |
| Acute renal failureRenal and urinary disorders | 1/26 | 0/28 |
| Hospitalisation for intrapleuric chemotherapy and thoracentesisGeneral disorders | 1/26 | 0/28 |
| Gastric volvulusGastrointestinal disorders | 0/26 | 1/28 |
| Event | Chemotherapy Alone | Chemotherapy + Trastuzumab |
|---|---|---|
| NeutropeniaBlood and lymphatic system disorders | 16/26 | 9/28 |
| LeukopeniaBlood and lymphatic system disorders | 13/26 | 7/28 |
| Other - unspecifiedGeneral disorders | 8/26 | 9/28 |
| NauseaGastrointestinal disorders | 8/26 | 1/28 |
| AstheniaGeneral disorders | 7/26 | 1/28 |
| AnemiaBlood and lymphatic system disorders | 5/26 | 1/28 |
| FeverGeneral disorders | 5/26 | 3/28 |
| VomitingGastrointestinal disorders | 5/26 | 1/28 |
| DiarrheaGastrointestinal disorders | 2/26 | 5/28 |
| AlopeciaSkin and subcutaneous tissue disorders | 3/26 | 3/28 |
Intent-to-treat (ITT) population: all randomized participants.
| Age, Continuous(years) | Chemotherapy Alone | Chemotherapy + Trastuzumab | Total |
|---|---|---|---|
| Median | 59 (38 to 81) | 57 (39 to 82) | 58 (38 to 82) |
| Sex: Female, Male(Participants) | Chemotherapy Alone | Chemotherapy + Trastuzumab | Total |
|---|---|---|---|
| Female | 29 | 29 | 58 |
| Male | 0 | 0 | 0 |
This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.
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