Caelyx, Cyclophosphamide and Herceptin in Patients With Metastatic Breast Cancer
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.
Drug: Liposomal Doxorubicin
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase IV.II, Clinical Trial, With the Combination of Pegylated Liposomal Doxorubicin (Caelyx), Cyclophosphamide and Trastuzumab (Herceptin) in Patients With Metastatic Breast Cancer With Overexpression of HER2/Neu|
- To evaluate objective response rate
- To evaluate the profile of toxicity
- To evaluate time to progression
- To evaluate overall survival
- To determinate duration of response
- To determinate time to failure of treatment
|Study Start Date:||February 2006|
|Study Completion Date:||July 2008|
|GEICAM (Spanish Breast Cancer Research Group)|
|San Sebastián de los Reyes, Madrid, Spain, 28703|
|Study Chair:||Miguel Martín, MD., PhD||Spanish Breast Cancer Reserach Group|