Conditions: Breast Cancer
Keywords: stage IA breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IB breast cancer estrogen receptor-negative breast cancer progesterone receptor-negative breast cancer triple-negative breast cancer low-dose maintenance chemotherapy stroma angiogenesis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1086
Healthy volunteers: no

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.

Arms:
arm 1: No further chemotherapy following standard adjuvant chemotherapy. arm 2: 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)

Interventions: intervention 1: Cyclophosphamide intervention 2: Methotrexate
Intervention descriptions: intervention 1: 50 mg/day orally continuously for 1 year intervention 2: 2.5 mg twice/day orally days 1 and 2 of every week for 1 year

Protocol document: