A Phase II Study of Bevacizumab With Docetaxel and Capecitabine in the Neoadjuvant Setting for Breast Cancer Patients
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 18
- Primary Endpoint
- Percentage of Participants With Pathological Complete Response (pCR)
Study Overview
Brief Summary
This study will evaluate the effect of Avastin (15mg/kg iv) in combination with Docetaxel and Xeloda, given as pre-operative therapy to patients with primary breast cancer. Avastin will be administered every 3 weeks, for the first 5 cycles of chemotherapy. The anticipated time on study treatment is 3-12 months.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •female patients, 18-70years of age;
- •histologically-proven invasive breast cancer;
- •no prior or current neoplasm except for non-melanoma skin cancer, or in situ cancer of the cervix;
- •no distant disease/secondary cancer.
Exclusion Criteria
- •pregnant or lactating women;
- •pre-operative local treatment for breast cancer;
- •prior or concurrent systemic antitumor therapy;
- •clinically significant cardiac disease.
Arms & Interventions
Neoadjuvant Therapy
Intervention: capecitabine [Xeloda] (Drug)
Neoadjuvant Therapy
Intervention: bevacizumab [Avastin] (Drug)
Neoadjuvant Therapy
Intervention: docetaxel (Drug)
Outcomes
Primary Outcomes
Percentage of Participants With Pathological Complete Response (pCR)
Time Frame: Baseline, 20-24 weeks (final surgery, performed 2 to 4 weeks after the last chemotherapy cycle [Week 18])
pCR was defined as the absence of signs for invasive tumor in the final surgical sample as judged by the local pathologist. Surgery was performed 2 to 4 weeks after the last chemotherapy cycle.
Secondary Outcomes
- Percentage of Participants With pCR, Clinical Complete Response (CR), or Clinical Partial Response (PR)(Baseline, 20-24 weeks (final surgery, performed 2 to 4 weeks after the last chemotherapy cycle [Week 18]))
- Percentage of Participants Undergoing Breast-Conserving Surgery(20-24 weeks (final surgery, performed 2 to 4 weeks after the last chemotherapy cycle [Week 18]))