NCT00684216

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

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

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: The Netherlands Cancer Institute · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

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).

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	capecitabine	200 mg, BID, PO, QD until progression of disease
DRUG	hormonal treatment (tamoxifen, exemestane, anastrozole or letrozole)	either tamoxifen or aromatase inhibitor (exemestane, anastrozole or letrozole), QD, until progression of disease

Timeline

• Start date: 2008-04-01
• Primary completion: 2012-05-01
• Completion: 2013-05-01
• First posted: 2008-05-26
• Last updated: 2017-09-14

Locations

1 site across 1 country: Netherlands