Randomized Phase II/III Study of Second-line Endocrine Treatment Followed by Capecitabine Versus Capecitabine Followed by Endocrine Treatment in Patients With Metastatic Estrogen Receptor Positive Breast Cancer
This is a randomized phase II/II study. Patients are randomized for the sequence
capecitabine-hormonal therapy versus hormonal therapy- capecitabine. At progression the
patient should receive the other protocol treatment (e.g. if the patient was randomized to
capecitabine, at progression the treatment should be switched to hormonal treatment).
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Quality of life during the study period: Physical functioning scale of the QLQ-C30; Global Health status/QoL of the QLQ-C30
every 6 weeks
No
Sjoerd Rodenhuis, MD
Principal Investigator
NKI-AvL
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
N07MAN
NCT00684216
April 2008
May 2013
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