Breast Cancer Clinical Trial
Official title:
Low-dose Cytotoxics as "Anti-angiogenesis Treatment" Following Adjuvant Induction Chemotherapy for Patients With ER-negative and PgR-negative Breast Cancer
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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