Phase 2
Completed N=56
A Study of Avastin (Bevacizumab) in Patients With Inflammatory or Locally Advanced Breast Cancer
Source: ClinicalTrials.gov NCT00559845 ↗Enrolled (actual)
56
Serious AEs
14.8%
Results posted
Apr 2018
Primary outcomePrimary: Percentage of Participants With Pathological Complete Response Following Principle Investigator Review — 23.2 percentage of participants
Summary
This single arm study will assess the efficacy and safety of sequential neoadjuvant chemotherapy and bevacizumab (Avastin), before surgery and/or radiotherapy, in participants with inflammatory or locally advanced operable breast cancer. Participants will receive 5-fluorouracil, epidoxorubicin and cyclophosphamide (FEC), followed by paclitaxel, given concomitantly with bevacizumab. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Pathological Complete Response Following Principle Investigator Review |
23.2 | — |
| SECONDARY Objective Response Rate |
59.0 | — |
| SECONDARY Percentage of Participants With Breast-Conserving Surgery |
17.0; 13.2 | — |
| SECONDARY Percentage of Participants With Disease-Free Interval |
92.2; 84.3; 80.4; 76.5; 76.5 | — |
| SECONDARY Overall Survival |
— | — |
| SECONDARY Percentage of Participants Experiencing Any Adverse Event |
100.0 | — |
Eligibility Criteria
Inclusion Criteria
- female participants, >=18 years of age;
- stage III, or inflammatory breast cancer;
- estrogen receptor/progesterone receptor (ER/PgR) positive or negative and human epidermal growth factor receptor 2 (HER-2) negative;
- normal left ventricular ejection fraction (LVEF).
Exclusion Criteria
- previous chemotherapy/endocrine therapy;
- evidence of distant metastatic disease;
- other primary tumors in last 5 years (except for adequately treated cancer in situ of the cervix, or basal cell skin cancer);
- chronic daily treatment with >325 milligram per day (mg/day) aspirin, or >75mg/day clopidogrel.
Data sourced from ClinicalTrials.gov (NCT00559845). 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.