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

NCT05891093 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 766

Last updated 2024-02-08

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05891093 on ClinicalTrials.gov