drugset
drugset / Trial / NCT05891093

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

NCT05891093 ↗

Phase 3 Recruiting 766 enrolled Fudan University
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2023-06-01
Primary completion
2028-05-31
Completion
2031-05-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Fluzoparib Small molecule 50 mg Oral
Background Abemaciclib Small molecule 50 mg Oral
Background Abemaciclib Small molecule 100 mg Oral
Background Abemaciclib Small molecule 150 mg Oral
Background Anastrozole Other / unclassified 1 mg Oral
Background Exemestane Small molecule 25 mg Oral
Background Goserelin Other / unclassified — —
Background Letrozole Other / unclassified 2.5 mg Oral
Background Leuprolide Other / unclassified — —
Background Tamoxifen Small molecule 10 mg Oral
Background Toremifene Small molecule 60 mg Oral

Indications

breast cancer