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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,086
50 mg/day orally continuously for 1 year
2.5 mg twice/day orally days 1 and 2 of every week for 1 year
Disease-free Survival
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.
Time frame: 5-year estimates, reported at a median follow-up of 6.9 years
Overall Survival
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.
Time frame: 5-year estimates, reported at a median follow-up of 6.9 years
Distant Recurrence-free Interval
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.
Time frame: 5-year estimates, reported at a median follow-up of 6.9 years
Breast Cancer-free Interval
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.
Time frame: 5-year estimates, reported at a median follow-up of 6.9 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Tweed Heads Hospital
Tweed Heads, New South Wales, Australia
Queen Elizabeth Hospital
Adelaide, South Australia, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Maroondah Hospital
East Ringwood, Victoria, Australia
Murray Valley Private Hospital and Cancer Treatment Centre
Wodonga, Victoria, Australia
Christchurch Hospital
Christchurch, Australia
CHU Liege - Domaine Universitaire du Sart Tilman
Liège, Belgium
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Fundacion Arturo Lopez Perez
Santiago, Chile
Centro de Estudios Oncologicos Santiago
Santiago, Chile
...and 26 more locations