Phase 2
Completed N=88
A Study of Avastin (Bevacizumab) in Combination With Herceptin (Trastuzumab) and Xeloda (Capecitabine) in Patients With HER2-Positive Breast Cancer
Source: ClinicalTrials.gov NCT00811135 ↗Enrolled (actual)
88
Serious AEs
22.7%
Results posted
Dec 2015
Primary outcomePrimary: Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) — 75.0 percentage of participants
Summary
This single arm study will assess the efficacy and safety of Avastin in combination with Herceptin and Xeloda as first-line treatment of patients with HER2-positive locally recurrent or metastatic breast cancer. Patients will receive 3-weekly treatment cycles of Herceptin (8mg/kg iv on day 1 of first cycle, followed by 6mg/kg iv maintenance dose on day 1 of subsequent cycles), Xeloda (1000mg/m2 bid po on days 1-14 of each treatment cycle) and Avastin (15mg/kg on day 2 of first treatment cycle,and on day 1 of each subsequent cycle).The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) |
75.0 | — |
| SECONDARY Number of Participants With Disease Progression or Death |
70 | — |
| SECONDARY Progression Free Survival (PFS) |
14.2 | — |
| SECONDARY Number of Participants With Overall Survival (OS) |
40 | — |
| SECONDARY Overall Survival (OS) |
31.8 | — |
| SECONDARY Number of Participants With Time to Progression (TTP) |
62 | — |
| SECONDARY Time to Progression (TTP) |
14.5 | — |
| SECONDARY Number of Participants With Response |
66 | — |
| SECONDARY Duration of Response (DR) |
12.7 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients, >=18 years of age;
- breast cancer with measurable locally recurrent or metastatic lesions;
- candidate for chemotherapy;
- HER2-positive disease;
- ECOG PS of =6 months before enrollment);
- chronic daily treatment with corticosteroids (>=10mg/day), aspirin (>325 mg/day) or clopidogrel (>75mg/day);
- other primary tumor within last 5 years, except for adequately treated cervical cancer in situ, squamous or basal cell skin cancer;
- uncontrolled hypertension or significant cardiovascular disease.
Data sourced from ClinicalTrials.gov (NCT00811135). 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.