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

Phase 2
18 Years
75 Years
Open (Enrolling)
Metastatic Breast Cancer

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Trial Information

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

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.

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

6. Pregnant or lactating women

7. Serious uncontrolled intercurrent infection

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

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

Type of Study:


Study Design:

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

Outcome Measure:

Progression free survival

Outcome Time Frame:

response evaluation every two cycles

Safety Issue:


Principal Investigator

Xichun Hu, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical Oncology Department


China: Ethics Committee

Study ID:

Fudan BR2012-11



Start Date:

May 2012

Completion Date:

December 2014

Related Keywords:

  • Metastatic Breast Cancer
  • Metastatic Breast Cancer, Her-2 negative Breast Cancer
  • Avastin, FOLFOX regimen
  • Breast Neoplasms