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Bevacizumab Plus Modified FOLFOX6 Regimen as the Salvage Treatment in Metastatic Breast Cancer (MBC) Patients

Metastatic Breast Cancer Clinical Trial

Official title:
Phase II Study of Bevacizumab Plus Modified FOLFOX6 Regimen as the Salvage Treatment in Patients With Metastatic Breast Cancer

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01658033
Study type Interventional
Source Fudan University
Contact
Status Completed
Phase Phase 2
Start date May 2012
Completion date November 2014
View Details
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