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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Invitation-only

Conditions: Breast

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

Study type: Observational

Funder types: Other

Identifiers

NCT06791161

NCC5094

Details and patient eligibility

About

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

Enrollment: 300 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 1 patient group

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

Treatment:

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