A single-site 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 ≥Second-line Therapy
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
132
Capecitabine will been given as a sequential treatment who are got benefit in capecitabine-base chemotherapy.
endocrine therapy will been given as a sequential treatment who are got benefit in capecitabine-base chemotherapy.Endocrine therapy is determined by the doctor, including any kind of letrozole, anastrozole, exemestane, fulvestrant, tamoxifen, toremifene, combined with or without drugs or surgery in the inhibition of ovarian function.
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
RECRUITINGProgression-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
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
Quality of life(QOL)（1）
change from enrolling to progression disease or death according EORTC QLQ-C30
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
Quality of life(QOL)（2）
change from enrolling to progression disease or death according 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 platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.