Breast
Conditions
Keywords
BRCA1/2 mutation
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
Interventions
DRUGEndocrine drug +CDK4/6 inhibitor or PRAP inhibitor or Endocrine drug +CDK4/6 inhibitor+PARP inhibitor
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
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Invasive Disease-Free Survival rate | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Distant relapse-free survival rate | 3 years |
| Overall survival rate | 3 years |
Countries
China
Outcome results
None listed