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

Information source: Fudan University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Metastatic Breast Cancer

Intervention: Avastin + mFOLFOX6 (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Fudan University

Official(s) and/or principal investigator(s):
Xichun Hu, PhD, Principal Investigator, Affiliation: Medical Oncology Department
Xichun Hu, PhD, Principal Investigator, Affiliation: Fudan University

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 Details

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

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

Primary outcome: Progression free survival

Secondary outcome: Number of adverse events

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.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Female.

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

Locations and Contacts

Fudan University Cancer Hospital, Shanghai, Shanghai 200032, China
Additional Information

Related publications:

Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002. CA Cancer J Clin. 2005 Mar-Apr;55(2):74-108.

Kamby C, Vejborg I, Kristensen B, Olsen LO, Mouridsen HT. Metastatic pattern in recurrent breast cancer. Special reference to intrathoracic recurrences. Cancer. 1988 Nov 15;62(10):2226-33.

Jemal A, Siegel R, Ward E, Murray T, Xu J, Thun MJ. Cancer statistics, 2007. CA Cancer J Clin. 2007 Jan-Feb;57(1):43-66.

Pectasides D, Pectasides M, Farmakis D, Bountouroglou N, Nikolaou M, Koumpou M, Mylonakis N, Kosmas C. Oxaliplatin plus high-dose leucovorin and 5-fluorouracil in pretreated advanced breast cancer: a phase II study. Ann Oncol. 2003 Apr;14(4):537-42.

Starting date: May 2012
Last updated: December 23, 2014

Page last updated: August 20, 2015

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