This is a prospective, randomized, open-label phase III clinical study on the efficacy and safety of fluzoparib combined with adjuvant endocrine therapy versus adjuvant endocrine therapy for HR+/HER2- SNF3-subtype early breast cancer.
This is a prospective, randomized, open-label phase III clinical study on the efficacy and safety of fluzoparib combined with adjuvant endocrine therapy versus adjuvant endocrine therapy for HR+/HER2- SNF3-subtype early breast cancer. A total of 766 patients with luminal-type early breast cancer who received surgery at the Fudan University Shanghai Cancer Cancer and were classified as SNF3 (proliferative) by SNF algorithm fusion clustering will be collected for this study. Before enrollment, the primary tumors of the patients were subjected to molecular typing based on H\&E slices combined with digital pathology, and subsequent enrollment could be considered if patient pathology was confirmed as SNF3 subtype.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
766
Fluzoparib 50mg bid orally for 1 year.
1mg, qd orally
2.5mg, qd orally
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGinvasive disease free survival (iDFS)
defined as occurrence of any of the following: ipsilateral invasive breast cancer recurrence, regional invasive breast cancer recurrence, distant recurrence, death attributable to any cause, contralateral invasive breast cancer, or second non-breast invasive cancer.In-situ events are not included.
Time frame: 5 years
distant relapse free survival (DRFS)
the time from operation to the first distant recurrence, and the cases of death without distant recurrence was censored at the time of the death
Time frame: 5 years
overall survival (OS)
the time from treatment to death, regardless of disease recurrence
Time frame: 5 years
Adverse Effects
an undesired harmful effect resulting from a medication or other intervention
Time frame: 5 years
Number of participants with Patient Reported Outcome (PRO)
a health outcome directly reported by the patient who experienced it.
Time frame: 5 years
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25mg, qd orally
10mg, bid orally
60mg, qd orally
150mg/100mg/50mg, bid orally for 2 years
Leuprorelin acetate, goserelin acetate
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
RECRUITINGGuangdong Academy of Medical Sciences Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
RECRUITINGSun Yat-sen University Cancer Center
Guangdong, Guangzhou, China
RECRUITINGAffiliated Hospital of Nantong University
Nantong, Jiangsu, China
RECRUITINGNorthern Jiangsu People's Hospital
Yangzhou, Jiangsu, China
RECRUITINGThe First Hospital of China Medical University
Shenyang, Liaoning, China
RECRUITINGLiaoning Cancer Hospital & Institute
Shenyang, Liaoning, China
RECRUITINGFudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITING...and 5 more locations