Caelyx as Primary Treatment for Patients With Breast Cancer and a History of Heart Disease and/or Age Over 65 Years (CAPRICE)
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|ClinicalTrials.gov Identifier: NCT00563953|
Recruitment Status : Completed
First Posted : November 27, 2007
Last Update Posted : October 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Liposomal pegylated doxorubicine||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||February 2011|
|Actual Study Completion Date :||August 2016|
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
- 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. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|