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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Xichun Hu, Fudan University
ClinicalTrials.gov Identifier:
NCT01658033
First received: July 27, 2012
Last updated: December 1, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Metastatic Breast Cancer
Drug: Avastin + mFOLFOX6
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: response evaluation every two cycles ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of adverse events [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 72
Study Start Date: May 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01658033

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

Publications:
Responsible Party: Xichun Hu, Associate director of medical oncology department, Fudan University
ClinicalTrials.gov Identifier: NCT01658033     History of Changes
Other Study ID Numbers: Fudan BR2012-11
Study First Received: July 27, 2012
Last Updated: December 1, 2013
Health Authority: China: Ethics Committee

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Leucovorin
Bevacizumab
Oxaliplatin
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Inhibitors

ClinicalTrials.gov processed this record on July 20, 2014