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

NCT06791161 | Enrolling By Invitation

• 1 other identifier: NCC5094
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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

Conditions

Breast

Keywords

BRCA1/2 mutation

Outcome Measures

Primary Outcomes (1)

• Invasive Disease-Free Survival rate

  3 years

Secondary Outcomes (2)

• Distant relapse-free survival rate

  3 years

• Overall survival rate

  3 years

Study Arms (1)

BRCA1/2 mutated HR+HER2- early high-risk breast cancer

Drug: Endocrine drug +CDK4/6 inhibitor or PRAP inhibitor or Endocrine drug +CDK4/6 inhibitor+PARP inhibitor

Interventions

Endocrine drug +CDK4/6 inhibitor or PRAP inhibitor or Endocrine drug +CDK4/6 inhibitor+PARP inhibitor DRUG

BRCA1/2 mutated hormone receptor-positive HER2-negative early high-risk breast cancer is treated with 3 3 treatment options after surgery：Endocrine drug +CDK4/6 inhibitor or PRAP inhibitor or Endocrine drug +CDK4/6 inhibitor+PARP inhibitor

BRCA1/2 mutated HR+HER2- early high-risk breast cancer

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

BRCA gene mutation HR+/HER2- Early high-risk breast cancer

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of department

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: January 24, 2025
• Study Start: January 19, 2025
• Primary Completion (Estimated): January 18, 2030
• Study Completion (Estimated): January 18, 2035
• Last Updated: February 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)