Phase 3
N=330
A Study of Herceptin (Trastuzumab) in Combination Chemotherapy in Women With Locally Advanced Breast Cancer
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01998906 ↗Enrolled (actual)
330
Serious AEs
10.7%
Results posted
Oct 2014
Primary outcome: Primary: Event-Free Survival (EFS) - Percentage of Participants With an Event — 40.0; 50.9; 42.4 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Trastuzumab (Drug); Doxorubicin (Drug); Paclitaxel (Drug); CMF (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Event-Free Survival (EFS) - Percentage of Participants With an Event |
40.0; 50.9; 42.4 | — |
| PRIMARY Event-Free Survival |
NA; 43.6; 64.5 | 0.0275 sig |
| PRIMARY Percentage of Participants Event Free at 1 Year |
89; 82; 80 | — |
| PRIMARY Percentage of Participants Event Free at 2 Years |
73; 61; 69 | — |
| PRIMARY Percentage of Participants Event Free at 3 Years |
65; 52; 63 | — |
| SECONDARY Percentage of Participants With Breast Pathological Complete Response (bpCR) |
44.3; 26.7; 19.2 | 0.0051 sig |
| SECONDARY Percentage of Participants With Total Pathological Complete Response (tpCR) |
40.0; 20.7; 18.2 | 0.0014 sig |
| SECONDARY Percentage of Participants Achieving Either Complete Response (CR) or Partial Response (PR) According to Modified Response Evaluation Criteria in Solid Tumors (RECIST) Criteria |
72.7; 66.4; 65.6 | 0.3077 |
| SECONDARY Overall Survival (OS) - Percentage of Participants With an Event |
19.1; 28.4; 21.2 | — |
| SECONDARY Overall Survival |
NA; NA; NA | 0.0555 |
| SECONDARY Percentage of Participants Surviving at 1 Year |
100; 99; 97 | — |
| SECONDARY Percentage of Participants Surviving at 2 Years |
95; 88; 90 | — |
| SECONDARY Percentage of Participants Surviving at 3 Years |
85; 78; 85 | — |
Summary
This study will assess the efficacy and safety of adding Herceptin to a paclitaxel-containing regimen followed by cyclophosphamide/methotrexate/fluorouracil (CMF) chemotherapy in women with locally advanced breast cancer and HER2/c-erbB-2 gene amplification. In a parallel observational study patients with HER2-negative disease will receive the same chemotherapy without Herceptin.
Eligibility Criteria
Inclusion Criteria
- female patients, >=18 years of age, with locally advanced breast cancer.
Exclusion Criteria
- previous therapy for any invasive malignancy.
Data sourced from ClinicalTrials.gov (NCT01998906). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.