drugset / Trial / NCT00684216

Second-line Endocrine Treatment Followed by Capecitabine Versus Capecitabine Followed by Endocrine Treatment in Patients With Metastatic ER Positive Breast Cancer

NCT00684216

Phase 2/3 Terminated 10 enrolled The Netherlands Cancer Institute
RandomizedCrossoverOpen-labelTreatment

Summary

This trial studies the effects on quality of life and on time to second progression of the sequence endocrine therapy-capecitabine versus the sequence capecitabine-endocrine treatment. It is anticipated that the time on study (which is the time between randomization and the discontinuation of the second treatment in the sequence) will be similar for both arms of the study. The quality of life during this period, however, could be better in the patient group receiving the most effective first agent in the sequence. If this proves to be true, the conventional wisdom that endocrine therapy should be continued until no further endocrine options remain, must be abandoned.

Timeline

Start
2008-04
Primary completion
2012-05
Completion
2013-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Anastrozole Other / unclassified
Comparator Capecitabine Small molecule 200 mg Oral
Comparator Exemestane Small molecule
Comparator Letrozole Other / unclassified
Comparator Tamoxifen Small molecule

Indications