Clinical trial NCT00121134
Conditions: Breast Cancer
Keywords: Bevacizumab Metronomic Chemotherapy Breast Cancer Stages II-III Invasive breast cancer stages II-III
Sponsor: Harold J. Burstein, MD, PhD
Start date: 2005-06-01; Completion date: 2011-05-01
Enrollment: 164 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to study the effects (good and bad) of bevacizumab alone, bevacizumab with low-dose continuous chemotherapy (called metronomic chemotherapy), or bevacizumab with capecitabine, on you and your cancer. The goals of the study will be to:

* Examine the safety of these drugs
* See how easy or difficult it is to be treated with them
* Monitor for any signs of recurrent cancer
* Look at blood markers that might indicate how the treatment is working

Detailed description:
This study is broken into 4 groups (A, B, C, and D). Enrollment closed to all groups in May 2008.

The first forty subjects (Group A) in this study were treated with Bevacizumab only, which is given through a vein over 1-2 hours every 3 weeks, for a total of approximately 12 months (17 cycles). Each cycle consists of 3 weeks.

The next forty subjects (Group B) were treated with Bevacizumab and metronomic CM chemotherapy. These subjects took cyclophosphamide (1 pill by mouth every day), methotrexate, (1 pill taken by mouth twice a day for the first two days of each week) and Bevacizumab (once every 3 weeks). The treatments with cyclophosphamide, methotrexate and Bevacizumab will continue for approximately 6 months (8 cycles). Then for the next 6 months, they received Bevacizumab treatments only. The total time on this study will be about 12 months (17 cycles).

The next forty subjects (Group C) were treated with Bevacizumab and Capecitabine chemotherapy. These subjects took Capecitabine pills twice a day for 14 days, then one week of rest, to complete a 21-day cycle. There will be a total of 6 cycles of Capecitabine, meaning 18 weeks of treatment with both Capecitabine and Bevacizumab. Then received Bevacizumab treatments only (11 cycles) to complete 12 months of therapy. Total duration of your treatment will be about 12 months or 17 cycles of therapy.

The last forty subjects (Group D) are being treated with Bevacizumab and Capecitabine chemotherapy on a different schedule. These subjects will take Capecitabine pills twice a day for 7 days, then one week of rest and repeat this for a total of 24 weeks (6 cycles). Each cycle will last for 4 weeks (28 days). There will be a total of 6 cycles of Capecitabine, meaning 24 weeks of treatment with both Capecitabine and Bevacizumab. Bevacizumab will be given every two weeks for a total of 24 weeks (6 cycles). Then they will receive Bevacizumab treatments only, every 3 weeks for additional 27 weeks (9 cycles) to complete 12 months of therapy. For the last 9 cycles of Bevacizumab therapy each cycle will consist of 3 weeks. Total duration of treatment will be about 12 months or 15 cycles of therapy.

Arms: arm 1: Bevacizumab Alone arm 2: Bevacizumab with cyclophosphamide and methotrexate arm 3: capecitabine, 14 days on/7 days off scheduling, and bevacizumab arm 4: capecitabine 7 days on/7 days off scheduling, and bevacizumab
Interventions: intervention 1: Bevacizumab intervention 2: Cyclophosphamide intervention 3: Methotrexate intervention 4: Capecitabine
Intervention descriptions: intervention 1: Group A: Once every 3 weeks for 12 months Group B: Once every 3 weeks for 12 months intervention 2: Once a day for 6 months intervention 3: Twice daily for the first two days of every week for 6 months intervention 4: Capecitabine: 2000 mg/m2 a day, on Days 1-14 of a 21 day cycle, for at total of 6 cycles (18 weeks)

Bevacizumab: 15 mg/kg IV day 1 every 3 weeks x 1 year (17 cycles)

Protocol documents: