Overview

This trial is active, not recruiting.

Condition breast cancer
Treatment liposomal pegylated doxorubicine
Phase phase 2
Sponsor SOLTI Breast Cancer Research Group
Collaborator Schering-Plough
Start date September 2007
End date February 2011
Trial size 66 participants
Trial identifier NCT00563953, 2007-001428-11, SOLTI0702

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
liposomal pegylated doxorubicine Caelyx
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.

Primary Outcomes

Measure
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

Measure
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.

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

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.
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by SOLTI Breast Cancer Research Group.