Caelyx as Primary Treatment for Patients With Breast Cancer and a History of Heart Disease and/or Age Over 65 Years (CAPRICE)

• 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. [ Time Frame: At surgery. ] [ Designated as safety issue: No ]
  

• Clinical response rate (complete plus partial responses). Clinical response will be assessed by imaging using the WHO criteria. [ Time Frame: Before and after treatment with paclitaxel. ] [ Designated as safety issue: No ]
  
• Breast-conserving surgery: tumorectomy or quadrantectomy with or without lymphadenectomy versus mastectomy. [ Time Frame: At surgery. ] [ Designated as safety issue: No ]
  
• Axillary node involvement after primary chemotherapy. [ Time Frame: At surgery. ] [ Designated as safety issue: No ]
  
• Left ventricular ejection fraction measured by echocardiography or MUGA. [ Time Frame: At baseline, every 2 doxorubicine cycles and before surgery. ] [ Designated as safety issue: Yes ]
  
• Cardiac sign/symptom questionnaire. [ Time Frame: At baseline, every 2 doxorubicine cycles and before surgery. ] [ Designated as safety issue: Yes ]
  
• Relapse-free survival at 5 years after surgery and overall survival at 5 years after study entry. [ Time Frame: Until 5 years after surgery. ] [ Designated as safety issue: No ]
  

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 anthracycline-induced cardiotoxicity.

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 mammary gland.

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.