Caelyx, Cyclophosphamide and Herceptin in Patients With Metastatic Breast Cancer

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

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

Sample size calculation will be done by means of Simon's method in 2 stages for phase II studies and will be based on the principal aim of the study (evaluation of the rate of objective response).

The hypothesis brings over of the efficiency of the treatment it will be accepted if a rate of objective response of at least 55 % is obtained, rejecting the efficiency of the treatment when the rate of response targets be lower than 35 %. In this case, considering an alpha error of 0.05 and 80 % power, 14 patients will be included in the first stage; the study would continue if more than 5 objective responses were found. The total number of patients to including in the study would be 44. The results will be significant if they find at least 20 objective responses.

Assuming a drop-out rate of 10 %, the total number of patients needed is 49 patients.

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)