Low-dose Oral Cyclophosphamide and Methotrexate Maintenance for Hormone Receptor-negative Early Breast Cancer
- Registration Number
- NCT00022516
- Lead Sponsor
- ETOP IBCSG Partners Foundation
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1086
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CM-Maintenance Methotrexate 12-month CM-maintenance regimen (C, cyclophosphamide 50 mg/day orally continuously and M, methotrexate 2.5 mg twice/day orally days 1 and 2 of every week for 1 year) CM-Maintenance Cyclophosphamide 12-month CM-maintenance regimen (C, cyclophosphamide 50 mg/day orally continuously and M, methotrexate 2.5 mg twice/day orally days 1 and 2 of every week for 1 year)
- Primary Outcome Measures
Name Time Method Disease-free Survival 5-year estimates, reported at a median follow-up of 6.9 years Estimated percentage of patients alive and disease-free at 5 years from randomization, where disease-free survival is defined as the time from randomization to the first appearance of one of the following: invasive breast cancer recurrence at local, regional, or distant site, invasive contralateral breast cancer, second (non-breast) invasive cancer, or death without cancer event; or censored at date of last follow-up.
- Secondary Outcome Measures
Name Time Method Breast Cancer-free Interval 5-year estimates, reported at a median follow-up of 6.9 years Estimated percentage of patients alive and disease-free at 5 years from randomization, where breast cancer-free interval is defined as the time from randomization to invasive breast cancer recurrence at local, regional, or distant site, or invasive contralateral breast cancer; or censored at date of last follow up.
Overall Survival 5-year estimates, reported at a median follow-up of 6.9 years Estimated percentage of patients alive and disease-free at 5 years from randomization, where overall survival is defined as the time from randomization to death from any cause; or censored at date last known alive.
Distant Recurrence-free Interval 5-year estimates, reported at a median follow-up of 6.9 years Estimated percentage of patients alive and disease-free at 5 years from randomization, where distant recurrence-free Interval is defined as the time from randomization to invasive breast cancer recurrence at distant site, or invasive contralateral breast cancer; or censored at date of last follow up.
Trial Locations
- Locations (36)
Christchurch Hospital
🇦🇺Christchurch, Australia
CHU Liege - Domaine Universitaire du Sart Tilman
🇧🇪Liege, Belgium
Ospedale Sant' Eugenio
🇮🇹Rome, Italy
Hospital Clinico Universidad de Chile
🇨🇱Santiago, Chile
Centro de Estudios Oncologicos Santiago
🇨🇱Santiago, Chile
Hospital Clinico San Borja Arriaran
🇨🇱Santiago, Chile
University of Ibadan Health Center
🇳🇬Ibadan, Nigeria
Institutul Oncologic - Universitatea de Medicina
🇷🇴Cluj-Napoca, Romania
Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni
🇨🇭Bellinzona, Switzerland
Inselspital Bern
🇨🇭Bern, Switzerland
Murray Valley Private Hospital and Cancer Treatment Centre
🇦🇺Wodonga, Victoria, Australia
Hospital Carlos Van Buren
🇨🇱Valparaiso, Chile
Kantonsspital Graubuenden
🇨🇭Chur, Switzerland
Kantonsspital - St. Gallen
🇨🇭St. Gallen, Switzerland
Box Hill Hospital
🇦🇺Box Hill, Victoria, Australia
Azienda Ospedaliera di Padova
🇮🇹Padova, Italy
Ospedale Civile Rimini
🇮🇹Rimini, Italy
Tweed Heads Hospital
🇦🇺Tweed Heads, New South Wales, Australia
Queen Elizabeth Hospital
🇦🇺Adelaide, South Australia, Australia
Maroondah Hospital
🇦🇺East Ringwood, Victoria, Australia
European Institute of Oncology
🇮🇹Milano, Italy
Fundacion Arturo Lopez Perez
🇨🇱Santiago, Chile
Hospital de Clinicas de Porto Alegre
🇧🇷Porto Alegre, Rio Grande do Sul, Brazil
Ospedali Riuniti di Bergamo
🇮🇹Bergamo, Italy
Ospedale degli Infermi - ASL 12
🇮🇹Biella, Italy
Ospedale Alessandro Manzoni
🇮🇹Lecco, Italy
Ospedale Civile Ramazzini
🇮🇹Carpi, Italy
Ospedale San Paolo
🇮🇹Milan, Italy
Policlinico Universitario Udine
🇮🇹Udine, Italy
Instituto Nacional de Enfermedades Neoplasicas
🇵🇪Lima, Peru
Sandton Oncology Centre
🇿🇦Johannesburg, South Africa
Kantonsspital Aarau
🇨🇭Aarau, Switzerland
FMH Onkologie/Haematologie
🇨🇭Rheinfelden, Switzerland
Regionalspital
🇨🇭Thun, Switzerland
UniversitaetsSpital Zuerich
🇨🇭Zurich, Switzerland
National Institute of Oncology - Budapest
🇭🇺Budapest, Hungary