A Multicenter Prospective Cohort Study of Adjuvant Therapy for BRCA1/2 Mutated Hormone Receptor-positive HER2-negative Early High-risk Breast Cancer

• Conditions: Breast
• Interventions: Drug: Endocrine drug +CDK4/6 inhibitor or PRAP inhibitor or Endocrine drug +CDK4/6 inhibitor+PARP inhibitor

• Registration Number: NCT06791161
• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Brief Summary

To evaluate the efficacy and safety of different adjuvant treatment options after surgery for early high-risk breast cancer with BRCA1/2 mutation HR+/HER2

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-17
• Study Start: 2025-01-19
• Study First Submitted QC: 2025-01-23
• Study First Posted: 2025-01-24
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-14
• Primary Completion: 2030-01-18
• Study Completion: 2035-01-18

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• ECOG score 0-1
• ER>10%, PR>10%, HER2(0)/HER2(1+)/HER2(2+) and no amplification of FISH
• BRCA1/2 gene mutation
• No other site metastases were detected by imaging evaluation after surgical treatment
• Non-PCR breast cancer after neoadjuvant therapy, or breast cancer with postoperative pathology indicating ≥pN2
• The patient had no major organ dysfunction

Exclusion Criteria

• Allergic to the investigational drug, inability to take the drug orally, or refusal of the medication regimen
• Has been enrolled in another study or has been discontinued for less than or equal to 4 weeks
• There is serious dysfunction of vital organs (heart, liver, kidney)
• Patients with other malignancies, except cured non-melanoma skin cancer, cervical carcinoma in situ and other tumors that have been cured for at least 5 years
• In other acute infectious disease or chronic infectious disease activity period
• A history of uncontrolled seizures, central nervous system disorders, or mental disorders
• There is a known history of human immunodeficiency virus

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BRCA1/2 mutated HR+HER2- early high-risk breast cancer	Endocrine drug +CDK4/6 inhibitor or PRAP inhibitor or Endocrine drug +CDK4/6 inhibitor+PARP inhibitor	-

Primary Outcome Measures

Name	Time	Method
Invasive Disease-Free Survival rate	3 years

Secondary Outcome Measures

Name	Time	Method
Distant relapse-free survival rate	3 years
Overall survival rate	3 years

Trial Locations

Locations (1)

Cancer Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China