Overview

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