An interventional study of Capecitabine and endocrine therapy in Breast Cancer, sponsored by Zhejiang Cancer Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-03-29.
Sponsored by Zhejiang Cancer Hospital · Not applicable, Interventional, and Treatment
A multi-sites study about the efficacy of sequential monotherapy: Capecitabine vs. endocrine therapy, in metastatic breast cancer patients with HR-positive \& HER2-negative after capecitabine-base chemotherapy.
capecitabine-base chemotherapy must be first-line chemotherapy.
12,547 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 132 is above the median of 72 across 9,305 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Zhejiang Cancer Hospital is the lead sponsor of 271 studies on the registry; 116 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Capecitabine 1250mg per BSA by mouth twice per day for 14 days, per 21 days as a cycle, until disease progress or toxicity can not be tolerated.
Drug: Capecitabine
endocrine therapy is be gived as a sequential treatment in Metastatic breast cancer patients who are got benefit in chemotreatment,the medcine will be confirmed by the patient's past-treatment.
Procedure: endocrine therapy
Capecitabine is be given as a sequential treatment in Metastatic breast cancer patients who are got benefit in chemo treatment.
Also known as: Xeloda
endocrine therapy is be given as a sequential treatment in Metastatic breast cancer patients who are got benefit in chemo treatment,the medicine will be confirmed by the patient's past-treatment.
Progression-free survival(PFS)
Progression-free survival (PFS) is defined as the time elapsed between enrolling and tumor progression or death from any cause
Time frame: From date of enrolling until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
clinical benefit rate(CBR)
the response is CR+PR+SD ≥ 24 weeks
Time frame: From date of enrolling until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
overall survival(OS)
the time elapsed between enrolling and death from any cause
Time frame: From date of enrolling until the date of death from any cause, assessed up to 3 years
Number of participants with Grade 3/4 adverse events
Number of Participants with Grade 3/4 Adverse Events
Time frame: From date of enrolling until the date of 1 month of stop treatment, assessed up to 3 years
QOL
change from enrolling to progression disease or death according EORTC QLQ-C30 and EORTC BR23
Time frame: From date of enrolling until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
This study is status unknown, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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Zhejiang Cancer Hospital