This study is a prospective, open-label, phase III clinical study for patients with HR+/HER2- advanced breast cancer.
Patients with SNF3 subtype of HR+/HER2- advanced breast cancer confirmed by the Department of Pathology and Key Laboratory of Breast Cancer of Fudan University Affiliated Cancer Hospital are planned to be enrolled. The main purpose is to evaluate the efficacy of PARP inhibitor in SNF3 subtype of HR+/HER2- advanced breast cancer in randomized controlled phase III clinical studies with larger sample size.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
307
breast cancer institute of Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China
PFS
time to progressive disease (according to RECIST1.1)
Time frame: Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 5 years)
ORR
The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1)
Time frame: andomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 5 years)
CBR
the percentage of subjects with CR+PR+SD and last more than 24 weeks in all of the participants.
Time frame: Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 5 years)
OS
time to death due to any cause
Time frame: Randomization to death from any cause, through the end of study (approximately 5 years)
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