Phase IV/II Trial With the Combination of Pegylated Liposomal Doxorubicin (Caelyx), Cyclophosphamide and Trastuzumab in Patients With Metastatic Breast Cancer With Overexpression of Human Epidermal Growth Factor Receptor 2 (HER2)/Neu

GEICAM/2004-05

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

2006-02-15

2008-07-01

2009-07-14

Completed

Early phase I

49

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)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 49, 'type': 'ACTUAL'}}

2023-04-04