A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Primary Breast Cancer
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.
Drug: bevacizumab [Avastin]
Drug: capecitabine [Xeloda]
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Bevacizumab With Docetaxel and Capecitabine in the Neoadjuvant Setting for Breast Cancer Patients|
- 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]) ] [ Designated as safety issue: No ]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.
- Percentage of Participants With pCR, Clinical Complete Response (CR), or Clinical Partial Response (PR) [ Time Frame: Baseline, 20-24 weeks (final surgery, performed 2 to 4 weeks after the last chemotherapy cycle [Week 18]) ] [ Designated as safety issue: No ]Percentage of participants with pCR plus the percentage of participants without pCR who achieved CR or PR as measured by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis less than [<] 10 millimeters [mm]). No new lesions. PR was defined as greater than or equal to (≥) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.
- Percentage of Participants Undergoing Breast-Conserving Surgery [ Time Frame: 20-24 weeks (final surgery, performed 2 to 4 weeks after the last chemotherapy cycle [Week 18]) ] [ Designated as safety issue: No ]Percentage of participants undergoing a breast-conserving procedure versus a modified radical mastectomy at final surgery, performed 2 to 4 weeks after the last chemotherapy cycle (Week 18)
|Study Start Date:||February 2006|
|Study Completion Date:||April 2008|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
|Experimental: Neoadjuvant Therapy||
Drug: bevacizumab [Avastin]
15 mg/kg iv on Day 1 of each 3-week cycle, 5 cyclesDrug: docetaxel
75 mg/m2 on Day 1 of each 3-week cycle, 6 cyclesDrug: capecitabine [Xeloda]
950 mg/m2, orally twice daily, evening of Day 1 until morning of Day 15, followed by a 7 day rest period, every 3 weeks
Please refer to this study by its ClinicalTrials.gov identifier: NCT02005549
|Salzburg, Austria, 5020|
|Study Chair:||Clinical Trials||Hoffmann-La Roche|