RecruitingPhase 3NCT05891093

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)

Sponsor

Fudan University

Enrollment

766 participants

Start Date

Jun 1, 2023

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding fluzoparib (a PARP inhibitor drug) to standard hormone therapy can improve outcomes for women with a specific subtype of early-stage, hormone receptor-positive, HER2-negative breast cancer after surgery. **You may be eligible if...** - You are a woman aged 18–70 - You had surgery for early breast cancer that is ER+/HER2- confirmed by biopsy - You have a good performance status (able to do most normal activities) **You may NOT be eligible if...** - You have HER2-positive breast cancer - You are outside the 18–70 age range - You have a poor performance status or serious health issues Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGFluzoparib

Fluzoparib 50mg bid orally for 1 year.

DRUGAnastrozole

1mg, qd orally

DRUGLetrozole

2.5mg, qd orally

DRUGExemestane

25mg, qd orally

DRUGTamoxifen

10mg, bid orally

DRUGToremifene

60mg, qd orally

DRUGAbemaciclib

150mg/100mg/50mg, bid orally for 2 years

DRUGLHRH agonist

Leuprorelin acetate, goserelin acetate

Locations(15)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, China

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Guangdong Academy of Medical Sciences Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Sun Yat-sen University Cancer Center

Guangdong, Guangzhou, China

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, China

The First Hospital of China Medical University

Shenyang, Liaoning, China

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University

Shanghai, Shanghai Municipality, China

Shanghai First Maternity and Infant Hospital

Shanghai, Shanghai Municipality, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Ningbo Medical Center Lihuili Hospital

Ningbo, Zhejiang, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05891093

Related Trials

Genomic Services Research Program

NCT025959571 location

Safety and Tolerability of ²¹²Pb-DOTAM-GRPR1 in Adult Subjects With Recurrent or Metastatic GRPR-expressing Tumors

NCT052833304 locations

A Synthetic Lethality-Focused Algorithm to Identify Therapeutic Options in Advanced Metastatic Breast Cancer (SYNTHESIS-Breast)

NCT070671381 location

Social and Environmental Determinants of Breast Cancer Survivorship: the Black Breast Cancer Survivor's Intervention (BBCSI)

NCT068852031 location

A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer

NCT06103864316 locations