NCT00022516

Low-dose Oral Cyclophosphamide and Methotrexate Maintenance for Hormone Receptor-negative Early Breast Cancer

Low-dose Cytotoxics as "Anti-angiogenesis Treatment" Following Adjuvant Induction Chemotherapy for Patients With ER-negative and PgR-negative Breast Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,086 (actual)
• Sponsor: ETOP IBCSG Partners Foundation · Network
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

This randomized, phase III trial was designed to test the efficacy of a low-dose chemotherapy-maintenance regimen, hypothesized to have anti-angiogenic activity, administered following standard chemotherapy in patients with early breast cancer whose tumors are hormone receptor negative.

Detailed description

PURPOSE: * Evaluate a low-dose cyclophosphamide and methotrexate chemotherapy-maintenance regimen in early breast cancer. * Compare the disease-free survival, overall survival, and systemic disease-free survival of patients treated with these regimens. * Compare the toxic effects of these regimens in these patients. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center, menopausal status (pre vs post), and approved induction chemotherapy (anthracycline and cyclophosphamide vs other agents). Treatment duration is 12 months of low-dose chemotherapy-maintenance regimen (CM-maintenance) vs no chemotherapy-maintenance regimen (no-CM) following standard adjuvant chemotherapy. Patients are randomized to one of two treatment arms. Patients are followed every 6 months for 5 years, and yearly follow-up thereafter.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Cyclophosphamide	50 mg/day orally continuously for 1 year
DRUG	Methotrexate	2.5 mg twice/day orally days 1 and 2 of every week for 1 year

Timeline

• Start date: 2000-11-01
• Primary completion: 2015-01-01
• Completion: 2016-08-01
• First posted: 2003-01-27
• Last updated: 2016-09-16
• Results posted: 2015-12-11

Locations

36 sites across 11 countries: Australia, Belgium, Brazil, Chile, Hungary, Italy, Nigeria, Peru, Romania, South Africa, Switzerland