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.
Overview
- Phase
- Phase 2
- Intervention
- Liposomal pegylated doxorubicine
- Conditions
- Breast Cancer
- Sponsor
- SOLTI Breast Cancer Research Group
- Enrollment
- 50
- Locations
- 8
- Primary Endpoint
- 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.
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
This is a multicenter study of a primary chemotherapy regimen in breast cancer patients at risk of developing cardiotoxicity. The aim of the study is to evaluate the response rate at surgery.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically confirmed invasive breast cancer (tumor \> 2 cm).
- •Estrogen receptor-negative or -weakly positive tumors (less than 50% of cells), as evaluated using IHC.
- •Risk factors for developing anthracycline-induced cardiomyopathy.
Exclusion Criteria
- •Severe heart failure (NYHA Class III or IV) .
- •Metastatic disease.
- •LVEF \< 45%.
- •Pregnant or breast-feeding patients.
Arms & Interventions
1
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.
Intervention: Liposomal pegylated doxorubicine
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Clinical response rate (complete plus partial responses). Clinical response will be assessed by imaging using the WHO criteria.(Before and after treatment with paclitaxel.)
- Breast-conserving surgery: tumorectomy or quadrantectomy with or without lymphadenectomy versus mastectomy.(At surgery.)
- Axillary node involvement after primary chemotherapy.(At surgery.)
- Left ventricular ejection fraction measured by echocardiography or MUGA.(At baseline, every 2 doxorubicine cycles and before surgery.)
- Cardiac sign/symptom questionnaire.(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.(Until 5 years after surgery.)