Maintenance Treatment With Liposomal Doxorubicin (Caelyx) in Metastatic Breast Cancer Patients
This is a randomized, prospective and multicenter phase IV clinical trial, which has been designed as a phase III study. One hundred fifty-four women (77 per treatment arm) will be recruited in the study.
Drug: Pegylated liposomal doxorubicin (Caelyx)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase IV.III Clinical Trial to Evaluate Maintenance Treatment With Caelyx vs. Observation After Administration of Induction Chemotherapy in Metastatic Breast Cancer Patients|
- Time to disease progression with maintenance Caelyx versus observation
- Assessment of single nucleotide polymorphisms (SNPs) for XPD, tubulin III, ERCC-1
|Study Start Date:||October 2002|
|Estimated Study Completion Date:||December 2006|
The main variable is time to disease progression. All patients must be treated with first line of induction chemotherapy, consisting of doxorubicin 75 mg/m2, day 1 every 3 weeks, and docetaxel, 100 mg/m2, day 1 every 3 weeks. Both drugs must be administered sequentially. Patients previously treated with anthracyclines must receive 2 courses of doxorubicin and 4 courses of docetaxel. Otherwise, patients will receive 3 courses of doxorubicin followed by 3 courses of docetaxel.
Patients with complete response, partial response or stable disease are eligible for GEICAM 2001-01 study.
The investigators assume that maintenance treatment with Caelyx will increase mean time to progression from 10, 46 months (observation) to 17, 43 months. Expected difference in mean time to progression is 6, 97 months (Hazard ratio = 0.6). With an alpha error of 0.01 (unilateral) and power of 80%, 77 patients per arm are needed, 154 patients in total.
|Spanish Breast Cancer Research Group (GEICAM)|
|San Sebastián de los Reyes, Madrid, Spain, 28700|
|Study Chair:||Emilio Alba, MD., PhD.||Spanish Breast Cancer Research Group (GEICAM)|