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

Metastatic Breast Cancer Clinical Trial

Official title:

Phase II Study of Bevacizumab Plus Modified FOLFOX6 Regimen as the Salvage Treatment in Patients With Metastatic Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01658033
• Other study ID #: Fudan BR2012-11
• Status: Completed
• Phase: Phase 2
• First received: July 27, 2012
• Last updated: September 8, 2015
• Start date: May 2012
• Est. completion date: November 2014

Study information

• Verified date: September 2015
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: November 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

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

Locations

Country	Name	City	State
China	Fudan University Cancer Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View 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. — View Citation

Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002. CA Cancer J Clin. 2005 Mar-Apr;55(2):74-108. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival		response evaluation every two cycles	No
Secondary	Number of adverse events		8 weeks	Yes