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

NCT01658033 | Completed Phase 2

• 1 other identifier: Fudan BR2012-11
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Breast Cancer

Keywords

Metastatic Breast Cancer, Her-2 negative Breast Cancer; Avastin, FOLFOX regimen

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  response evaluation every two cycles

Secondary Outcomes (1)

• Number of adverse events

  8 weeks

Study Arms (1)

Avastin + mFOLFOX6

EXPERIMENTAL

Avastin plus FOLFOX6 regimen in the management of her-2 negative breast cancer patients.

Drug: Avastin + mFOLFOX6

Interventions

Avastin + mFOLFOX6 DRUG

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

Also known as: Avastin, Oxaliplatin, Leucovorin, 5-FU

Avastin + mFOLFOX6

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age\>=18years
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) \<=2 and a life expectancy \>= 12 weeks;
• histological-proven, HER-2 negative measurable stage IV disease;
• 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
• Patients previously treated with radiotherapy were eligible for the study, provided that measurable disease existed outside the radiation field.
• At least 3 weeks from the prior chemotherapy or radiotherapy. At least 2 weeks from the prior endocrine therapy.

You may not qualify if:

• Patients with active infection or other serious underlying medical conditions
• Patients had prior treatment with 5-FU infusion and/or oxaliplatin therapy
• Inadequate bone marrow, liver, renal, medullary, and cardiac functions
• Evidence of spinal cord compression or brain metastasis
• 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
• Pregnant or lactating women
• Serious uncontrolled intercurrent infection
• History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding
• Serious non-bleeding wound, peptic ulcer or bone fracture
• Prior dihypopyrimidine dehydrogenase deficiency
• Hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanlised antibodies

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (5)

• Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002. CA Cancer J Clin. 2005 Mar-Apr;55(2):74-108. doi: 10.3322/canjclin.55.2.74.

  PMID: 15761078 BACKGROUND

• 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.

  PMID: 3179937 BACKGROUND

• 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.

  PMID: 17237035 BACKGROUND

• 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.

  PMID: 12649097 BACKGROUND

• 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.

  PMID: 26186012 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Bevacizumab; Oxaliplatin; Leucovorin; Fluorouracil

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Xichun Hu, PhD

  Medical Oncology Department

  PRINCIPAL INVESTIGATOR

• Xichun Hu, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate director of medical oncology department

Study Record Dates

• First Submitted: July 27, 2012
• First Posted: August 6, 2012
• Study Start: May 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2014
• Last Updated: September 9, 2015

Record last verified: 2015-09

Locations

CN (1)