Caelyx as Primary Treatment for Patients With Breast Cancer and a History of Heart Disease and/or Age Over 65 Years (CAPRICE)
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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.|
- 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. ]
- 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. ]
- Breast-conserving surgery: tumorectomy or quadrantectomy with or without lymphadenectomy versus mastectomy. [ Time Frame: At surgery. ]
- Axillary node involvement after primary chemotherapy. [ Time Frame: At surgery. ]
- Left ventricular ejection fraction measured by echocardiography or MUGA. [ Time Frame: At baseline, every 2 doxorubicine cycles and before surgery. ]
- Cardiac sign/symptom questionnaire. [ Time Frame: At baseline, every 2 doxorubicine cycles and before surgery. ]
- Relapse-free survival at 5 years after surgery and overall survival at 5 years after study entry. [ Time Frame: Until 5 years after surgery. ]
|Study Start Date:||September 2007|
|Study Completion Date:||August 2016|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
Primary chemotherapy regimen consisting of four cycles of pegylated-liposomal doxorubicine at 35 mg/m² IV plus CPM 600 mg/m² on Day 1 every 4 weeks followed by paclitaxel 80 mg/m²/week for 12 weeks before surgery.
Drug: Liposomal pegylated doxorubicine
Four cycles of liposomal pegylated doxorubicine at 35 mg/m² IV combined with cyclophosphamide at 600 mg/m² on Day 1 every 4 weeks, and followed by paclitaxel 80 mg/m²/week for 12 weeks before surgery.
Other Name: Caelyx
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00563953
|Institut Català d'Oncologia|
|L'Hospitalet de Llobregat, Barcelona, Spain, 08907|
|Hospital Son Llàtzer|
|Palma de Mallorca, Illes Balears, Spain, 07198|
|Hospital Universitario Sant Joan de Reus|
|Reus, Tarragona, Spain, 42301|
|Hospital de la Santa Creu i Sant Pau|
|Barcelona, Spain, 08025|
|Hospital Universitari Vall d'Hebron|
|Barcelona, Spain, 08035|
|Hospital Universitari Arnau de Vilanova|
|Lleida, Spain, 25198|
|Hospital Universitario 12 de Octubre|
|Madrid, Spain, 28041|
|Hospital Universitario Morales Meseguer|
|Murcia, Spain, 30008|
|Study Chair:||Miguel Gil, MD||Institut Català d'Oncologia|