Phase II, Open Label, Neoadjuvant Study of Bevacizumab in Patients With Inflammatory or Locally Advanced Breast Cancer
Overview
- Phase
- Phase 2
- Intervention
- 5-fluorouracil
- Conditions
- Breast Cancer
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 56
- Primary Endpoint
- Percentage of Participants With Pathological Complete Response Following Principle Investigator Review
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief 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.
Investigators
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.
Arms & Interventions
Bevacizumab
Participants will receive FEC, followed by paclitaxel, given concomitantly with bevacizumab for approximately 3-12 months.
Intervention: 5-fluorouracil
Bevacizumab
Participants will receive FEC, followed by paclitaxel, given concomitantly with bevacizumab for approximately 3-12 months.
Intervention: Epidoxorubicin
Bevacizumab
Participants will receive FEC, followed by paclitaxel, given concomitantly with bevacizumab for approximately 3-12 months.
Intervention: Cyclophosphamide
Bevacizumab
Participants will receive FEC, followed by paclitaxel, given concomitantly with bevacizumab for approximately 3-12 months.
Intervention: Paclitaxel
Bevacizumab
Participants will receive FEC, followed by paclitaxel, given concomitantly with bevacizumab for approximately 3-12 months.
Intervention: Bevacizumab
Outcomes
Primary Outcomes
Percentage of Participants With Pathological Complete Response Following Principle Investigator Review
Time Frame: Up to 7.5 years
Pathological complete response was defined as absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy.
Secondary Outcomes
- Percentage of Participants With Disease-Free Interval(Months 12, 24, 36, 48, and 60)
- Objective Response Rate(Up to 7.5 years)
- Percentage of Participants With Breast-Conserving Surgery(Up to 7.5 years)
- Percentage of Participants Experiencing Any Adverse Event(Up to 7.5 years)
- Overall Survival(Up to 7.5 years)