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Enrolling by invitation NCT06791161

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

— Observational Breast

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Endocrine drug +CDK4/6 inhibitor or PRAP inhibitor or Endocrine drug +CDK4/6 inhibitor+PARP inhibitor.
Who it may be relevant to
Registry conditions: Breast. Basic parameters: 18 years — 75 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • Drug 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

Primary outcome measures

  • Invasive Disease-Free Survival rate [Time frame: 3 years]
Secondary outcome measures (2)
  • Distant relapse-free survival rate [Time frame: 3 years]
  • Overall survival rate [Time frame: 3 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Cancer Hospital, Chinese Academy of Medical Sciences — Beijing

Identifiers

NCT: NCT06791161 · NCC5094

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗