Clinical trial · Observational
A Multicenter Prospective Cohort Study of Adjuvant Therapy for BRCA1/2 Mutated Hormone Receptor-positive HER2-negative Early High-risk Breast Cancer
NCT06791161CI-TRIAL-00086025enrolling by invitationClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endocrine drug +CDK4/6 inhibitor or PRAP inhibitor or Endocrine drug +CDK4/6 inhibitor+PARP inhibitor | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- BRCA1/2 mutated HR+HER2- early high-risk breast cancer
- interventionNames
- Drug: Endocrine drug +CDK4/6 inhibitor or PRAP inhibitor or Endocrine drug +CDK4/6 inhibitor+PARP inhibitor
Primary outcomes (1)
- measure
- Invasive Disease-Free Survival rate
- timeFrame
- 3 years
Secondary outcomes (2)
- measure
- Distant relapse-free survival rate
- timeFrame
- 3 years
- measure
- Overall survival rate
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.