Maintenance Treatment With Liposomal Doxorubicin (Caelyx) in Metastatic Breast Cancer Patients
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|ClinicalTrials.gov Identifier: NCT00128778|
Recruitment Status : Completed
First Posted : August 10, 2005
Last Update Posted : September 5, 2007
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasms||Drug: Pegylated liposomal doxorubicin (Caelyx)||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||154 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||October 2002|
|Estimated Study Completion Date :||December 2006|
- Time to disease progression with maintenance Caelyx versus observation
- Assessment of single nucleotide polymorphisms (SNPs) for XPD, tubulin III, ERCC-1
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00128778
|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)|