Clinical trial NCT01658033: Bevacizumab Plus Modified FOLFOX6 Regimen as the Salvage Treatment in Metastatic Breast Cancer (MBC) Patients
Official title: Phase II Study of Bevacizumab Plus Modified FOLFOX6 Regimen as the Salvage Treatment in Patients With Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Breast Cancer
Keywords: Metastatic Breast Cancer, Her-2 negative Breast Cancer
Avastin, FOLFOX regimen
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2012-08-06
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Progression free survival
timeFrame: response evaluation every two cycles
Secondary outcomes:
measure: Number of adverse events
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Cancer Hospital
state: Shanghai
Study officials:
affiliation: Medical Oncology Department
name: Xichun Hu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fudan University
name: Xichun Hu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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. doi: 10.1002/1097-0142(19881115)62:103.0.co;2-d.
citation: 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. doi: 10.3322/canjclin.57.1.43.
citation: 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. doi: 10.1093/annonc/mdg172.
citation: Li T, Wang B, Wang Z, Ragaz J, Zhang J, Sun S, Cao J, Lv F, Wang L, Zhang S, Ni C, Wu Z, Xie J, Hu X. Bevacizumab in Combination with Modified FOLFOX6 in Heavily Pretreated Patients with HER2/Neu-Negative Metastatic Breast Cancer: A Phase II Clinical Trial. PLoS One. 2015 Jul 17;10(7):e0133133. doi: 10.1371/journal.pone.0133133. eCollection 2015.