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

Phase 2

Completed

• Conditions: Metastatic Breast Cancer
• Interventions: Drug: Avastin + mFOLFOX6

• Registration Number: NCT01658033
• Lead Sponsor: Fudan University

Brief 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.

Detailed 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 Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-07-27
• Study First Submitted QC: 2012-08-01
• Study First Posted: 2012-08-06
• Primary Completion: 2013-11
• Study Completion: 2014-11
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-08
• Last Update Posted: 2015-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Avastin + mFOLFOX6	Avastin + mFOLFOX6	Avastin plus FOLFOX6 regimen in the management of her-2 negative breast cancer patients.

Primary Outcome Measures

Name	Time	Method
Progression free survival	response evaluation every two cycles

Secondary Outcome Measures

Name	Time	Method
Number of adverse events	8 weeks

Trial Locations

Locations (1)

Fudan University Cancer Hospital; 🇨🇳 Shanghai, Shanghai, China