NCT00258960

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Spanish Breast Cancer Research Group · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Liposomal Doxorubicin
DRUG	Cyclophosphamide
DRUG	Trastuzumab

Timeline

• Start date: 2006-02-15
• Primary completion: 2008-07-01
• Completion: 2009-07-14
• First posted: 2005-11-28
• Last updated: 2023-04-04
• Results posted: 2019-07-15

Locations

12 sites across 1 country: Spain