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Enrolling by Invitation

NCT Number: NCT06791161

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

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

Enrolling by Invitation

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Invasive Disease-Free Survival rate

    Time frame: 3 years

Secondary outcomes

  1. Distant relapse-free survival rate

    Time frame: 3 years

  2. Overall survival rate

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Important dates

Study start
2025
Primary completion
2030
Study completion
2035
First posted
Jan 24, 2025
Registry last updated
Feb 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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