A Phase II, Open-Label, Multicenter Clinical Trial of Pegylated Liposomal Doxorubicin (Caelyx®) as Primary Treatment for Patients With Breast Cancer and a History of Heart Disease or Age Over 65 Years.
This is a phase II, uncontrolled, open label, multicenter study of a primary chemotherapy
regimen consisting of four cycles of liposomal pegylated doxorubicine 35 mg/m² IV plus
cyclophosphamide 600 mg/m² on Day 1 every 4 weeks followed by paclitaxel 80 mg/m²/week for
12 weeks before surgery in breast cancer patients at risk of developing
Surgery (tumorectomy, quadrantectomy, or mastectomy plus lymphadenectomy) will be performed
2 to 5 weeks after the last primary chemotherapy infusion.
Patients with > 10% of hormone receptor-positive cells will receive appropriate hormone
therapy according to menopausal status.
Patients treated with breast-conserving surgery will receive radiation therapy to the
Patients with T4 tumors or significant axillary involvement (≥ ypN2) will receive radiation
therapy to the breast or chest wall and to the lymph node chains.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Pathological complete response (pCR). pCR is defined as the absence of invasive cancer in the surgical breast specimen. This definition includes evidence of carcinoma in situ only.
Miguel Gil, MD
Institut Català d'Oncologia
Spain: Spanish Agency of Medicines