Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Phase
Observational
Started
2025-01-19
Last updated
2025-02-14
Condition(s) studied
Breast
Investigational drug(s) / intervention(s)
Endocrine drug +CDK4/6 inhibitor or PRAP inhibitor or Endocrine drug +CDK4/6 inhibitor+PARP inhibitor
Endocrine 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
Study 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
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
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
Primary outcome measure(s)
Invasive Disease-Free Survival rate — 3 years
Trial sites (1)
Facility
City
Region
Status
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing
Beijing Municipality
More Cancer Institute and Hospital, Chinese Academy of Medical Sciences trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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