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

July 27, 2012
December 1, 2013
May 2012
August 2014   (final data collection date for primary outcome measure)
Progression free survival [ Time Frame: response evaluation every two cycles ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01658033 on ClinicalTrials.gov Archive Site
Number of adverse events [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Bevacizumab Plus Modified FOLFOX6 Regimen as the Salvage Treatment in Metastatic Breast Cancer (MBC) Patients
Phase II Study of Bevacizumab Plus Modified FOLFOX6 Regimen as the Salvage Treatment in Patients With Metastatic Breast Cancer

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.

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Breast Cancer
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
Experimental: Avastin + mFOLFOX6
Avastin plus FOLFOX6 regimen in the management of her-2 negative breast cancer patients.
Intervention: Drug: Avastin + mFOLFOX6

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
72
June 2015
August 2014   (final data collection date for primary outcome measure)

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
Female
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01658033
Fudan BR2012-11
No
Xichun Hu, Fudan University
Fudan University
Not Provided
Principal Investigator: Xichun Hu, PhD Medical Oncology Department
Principal Investigator: Xichun Hu, PhD Fudan University
Fudan University
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP