Neoadjuvant Pegylated Liposomal Doxorubicin and Cyclophosphamide +/- Trastuzumab Followed by Docetaxel in Breast Cancer

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to determine the efficacy of neoadjuvant treatment with pegylated liposomal doxorubicin (Caelyx) and cyclophosphamide +/- trastuzumab followed by docetaxel in patients with locally advanced, inflammatory breast cancer or with a primary tumor > 5 cm.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Herlev Hospital
• Collaborators: Aarhus University Hospital; Odense University Hospital; Rigshospitalet, Denmark
• Treatments: Cyclophosphamide; Docetaxel; Doxorubicin; Liposomal doxorubicin; Trastuzumab

Criteria

Inclusion Criteria:

• pathologically proven breast cancer

• inflammatory, locally advanced breast cancer or a tumor > 5 cm

• ECOG performance status < 2

• LVEF > 50% measured by MUGA (HER2 positive patients)

• adequate bone marrow, liver and renal function

• written informed consent must be obtained

Exclusion Criteria:

• another malignancy within 5 years prior to study entry

• concurrent treatment with an investigational agent

• other disease or condition that contraindicates participation in the study

• pregnant or lactating females