Phase IV.III Clinical Trial to Evaluate Maintenance Treatment With Caelyx vs. Observation After Administration of Induction Chemotherapy in Metastatic Breast Cancer Patients
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
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to disease progression with maintenance Caelyx versus observation
Emilio Alba, MD., PhD.
Spanish Breast Cancer Research Group (GEICAM)
Spain: Spanish Agency of Medicines