NCT05891093

Efficacy and Safety of Fluzoparib Combined With Adjuvant Endocrine Therapy for HR+/HER2- SNF3-subtype Early Breast Cancer (BCTOP-L-A01)

A Prospective, Randomized, Open-label Phase III Clinical Study of the Efficacy and Safety of Fluzoparib Combined With Adjuvant Endocrine Therapy Versus Adjuvant Endocrine Therapy for HR+/HER2- SNF3-subtype Early Breast Cancer (BCTOP-L-A01)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 766 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Fluzoparib	Fluzoparib 50mg bid orally for 1 year.
DRUG	Anastrozole	1mg, qd orally
DRUG	Letrozole	2.5mg, qd orally
DRUG	Exemestane	25mg, qd orally
DRUG	Tamoxifen	10mg, bid orally
DRUG	Toremifene	60mg, qd orally
DRUG	Abemaciclib	150mg/100mg/50mg, bid orally for 2 years
DRUG	LHRH agonist	Leuprorelin acetate, goserelin acetate

Timeline

• Start date: 2023-06-01
• Primary completion: 2028-05-31
• Completion: 2031-05-31
• First posted: 2023-06-06
• Last updated: 2024-02-08

Locations

15 sites across 1 country: China