Caelyx, Cyclophosphamide and Herceptin in Patients With Metastatic Breast Cancer

• Status: Completed
• Trial end date: 2009-07-14
• Target enrollment: 0
• Participant gender: Female

Summary

Eligible patients must receive Caelyx plus Cyclophosphamide plus Herceptin for 6 cycles that will be administered every 4 weeks.

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

Details

• Lead Sponsor: Spanish Breast Cancer Research Group
• Collaborator: Schering-Plough
• Treatments: Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Trastuzumab

Criteria

Inclusion Criteria:

• Patients must sign an informed consent before of specific procedures of clinical trial.

• Patients with histologically confirmed breast cancer and overexpression of Her2neu.

• Age> 18 years.

• Eastern Cooperative Oncology Group (ECOG) equal or < 2.

• Patients have not been treated previously with chemotherapy for metastatic disease.

• Patients must have at least one measurable lesion according to RECIST criteria.

• Patients should have an adequate organ function to tolerate chemotherapy.

Exclusion Criteria:

• Patients with hypersensitivity reactions to any of the medications of the clinical trial.

• Patients who are pregnant or lactating are not eligible.

• Hepatic disease.

• Not controlled active infection

• Symptomatic metastatic brain cancer

• Previous adjuvant treatment with anthracyclines with a total accumulated dose > 300 mg/m2 (Doxorubicin) or > 600 mg/m2 (Epirubicin)