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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01658033
Recruitment Status : Completed
First Posted : August 6, 2012
Last Update Posted : September 9, 2015
Information provided by (Responsible Party):
Xichun Hu, 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.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: Avastin + mFOLFOX6 Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Bevacizumab Plus Modified FOLFOX6 Regimen as the Salvage Treatment in Patients With Metastatic Breast Cancer
Study Start Date : May 2012
Primary Completion Date : November 2013
Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Bevacizumab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Avastin + mFOLFOX6
Avastin plus FOLFOX6 regimen in the management of her-2 negative breast cancer patients.
Drug: Avastin + mFOLFOX6

mFOLFOX6 regimen, repeated every 2 weeks: Oxaliplatin 85 mg/m2,ivgtt; Leucovorin 400 mg/m2,ivgtt; 5-FU 400 mg/m2,iv,and then 2400 mg/m2,civ46h;

Avastin: Avastin 5mg/kg q2w or 7.5mg/kg q3w

Other Names:
  • Avastin
  • Oxaliplatin
  • Leucovorin
  • 5-FU

Primary Outcome Measures :
  1. Progression free survival [ Time Frame: response evaluation every two cycles ]

Secondary Outcome Measures :
  1. Number of adverse events [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01658033

China, Shanghai
Fudan University Cancer Hospital
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Fudan University
Principal Investigator: Xichun Hu, PhD Medical Oncology Department
Principal Investigator: Xichun Hu, PhD Fudan University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Xichun Hu, Associate director of medical oncology department, Fudan University Identifier: NCT01658033     History of Changes
Other Study ID Numbers: Fudan BR2012-11
First Posted: August 6, 2012    Key Record Dates
Last Update Posted: September 9, 2015
Last Verified: September 2015

Keywords provided by Xichun Hu, Fudan University:
Metastatic Breast Cancer, Her-2 negative Breast Cancer
Avastin, FOLFOX regimen

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents