Bevacizumab Plus Modified FOLFOX6 Regimen as the Salvage Treatment in Metastatic Breast Cancer (MBC) Patients
The objective of this phase II study is to evaluate efficacy and safety of avastin plus modified FOLFOX6 regimen in HER-2 negative metastatic breast cancer patients. Fifty-five patients will be enrolled into this study.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Bevacizumab Plus Modified FOLFOX6 Regimen as the Salvage Treatment in Patients With Metastatic Breast Cancer|
- Progression free survival [ Time Frame: response evaluation every two cycles ] [ Designated as safety issue: No ]
- Number of adverse events [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
Experimental: Avastin + mFOLFOX6
Avastin plus FOLFOX6 regimen in the management of her-2 negative breast cancer patients.
Drug: Avastin + mFOLFOX6
mFOLFOX6 regimen, repeated every 2 weeks: Oxaliplatin 85 mg/m2，ivgtt； Leucovorin 400 mg/m2,ivgtt； 5-FU 400 mg/m2，iv，and then 2400 mg/m2，civ46h；
Avastin: Avastin 5mg/kg q2w or 7.5mg/kg q3w
Anthracyclines and taxanes are the most frequently used agents for breast cancer,both in adjuvant and in first-line metastatic settings.For the patients who do not respond or relapse early after the administration of a taxane or anthracycline regimen,it is clearly needed to explore new combinations and schedules of drugs.Oxaliplatin has shown very promising activity in MBC either in monotherapy or in combination with 5-fluorouracil(5-FU) with or without leucovorin (LV). Avastin is a target therapy with proven efficacy in the treatment of MBC. Avastin plus FOLFOX regimen showed synergetic effet and been used as the standard trial in metastatic colorectal cancer patients. Based on the above reason, we initiate this phase II study to evaluate efficacy and safety of avastin plus modified FOLFOX6 regimen in HER-2 negative metastatic breast cancer patients.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01658033
|Fudan University Cancer Hospital|
|Shanghai, Shanghai, China, 200032|
|Principal Investigator:||Xichun Hu, PhD||Medical Oncology Department|
|Principal Investigator:||Xichun Hu, PhD||Fudan University|