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

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Bevacizumab; Leucovorin; Oxaliplatin

Criteria

Inclusion Criteria:

1. age>=18years

2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) <=2 and a life expectancy >= 12 weeks;

3. histological-proven, HER-2 negative measurable stage IV disease;

4. exposure to anthracyclines, taxanes either in the neoadjuvant/adjuvant or in the metastatic setting and had documented disease progression after the firstline or secondline treatment

5. Patients previously treated with radiotherapy were eligible for the study, provided that measurable disease existed outside the radiation field.

6. At least 3 weeks from the prior chemotherapy or radiotherapy. At least 2 weeks from the prior endocrine therapy.

Exclusion Criteria:

1. Patients with active infection or other serious underlying medical conditions

2. Patients had prior treatment with 5-FU infusion and/or oxaliplatin therapy

3. Inadequate bone marrow, liver, renal, medullary, and cardiac functions

4. Evidence of spinal cord compression or brain metastasis

5. History of another malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix or a contralateral breast cancer

6. Pregnant or lactating women

7. Serious uncontrolled intercurrent infection

8. History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding

9. Serious non-bleeding wound, peptic ulcer or bone fracture

10. Prior dihypopyrimidine dehydrogenase deficiency

11. Hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanlised antibodies