Phase 3
Completed N=424
A Study of Avastin (Bevacizumab) in Combination With Herceptin (Trastuzumab)/Docetaxel in Patients With HER2 Positive Metastatic Breast Cancer.
Source: ClinicalTrials.gov NCT00391092 ↗Enrolled (actual)
424
Serious AEs
32.1%
Results posted
Aug 2015
Primary outcomePrimary: Progression Free Survival (PFS) — 13.7; 16.5 months — p=0.0775
Summary
This 2 arm study will compare the efficacy and safety of Avastin plus Herceptin/docetaxel, versus Herceptin/docetaxel alone, in patients with HER2 positive locally recurrent or metastatic breast cancer who have not received prior chemotherapy for their metastatic disease. Patients will be randomized 1:1 to receive either Avastin (15mg/kg iv q3weeks) + Herceptin (8mg/kg iv loading dose and 6mg/kg iv q3weeks maintenance) + docetaxel (100mg/m2 iv q3weeks) or Herceptin + docetaxel alone. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) |
13.7; 16.5 | 0.0775 |
| SECONDARY Overall Survival (OS) |
38.3; 38.5 | 0.9543 |
| SECONDARY Percentage of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Partial Response (PR) in Participants With Measurable Disease at Baseline |
69.9; 74.3 | 0.3492 |
| SECONDARY Duration of Response (DR) |
11.4; 14.6 | — |
| SECONDARY Time to Treatment Failure (TTF) |
7.7; 9.8 | 0.5392 |
| SECONDARY Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores |
21.20; 21.47; 20.59; 20.88; 14.95; 15.54 | — |
| SECONDARY Change From Baseline for FACT-G and FACT-B |
-1.01; -1.51; 0.05; 0.32; 1.52; 1.16 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients, >=18 years of age;
- HER2 positive breast cancer with locally recurrent or metastatic lesions;
- eligible for chemotherapy;
- baseline LVEF >=50%.
Exclusion Criteria
- previous chemotherapy for metastatic or locally recurrent breast cancer;
- previous radiotherapy for metastatic breast cancer (except for metastatic bone pain relief);
- other primary tumor within last 5 years, with the exception of basal or squamous skin cancer, or in situ cancer of the cervix;
- clinically significant cardiovascular disease;
- chronic daily treatment with aspirin (>325mg/day) or clopidogrel (>75mg/day).
Data sourced from ClinicalTrials.gov (NCT00391092). 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. Informational only — not medical advice.