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  1. Home
  3. Niraparib Plus Aromatase Inhibitors For Hormone Receptor-positive/her2-negative Advanced Breast Cancer With A Germline Brca Mutation.
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  3. Niraparib Plus Aromatase Inhibitors For Hormone Receptor-positive/her2-negative Advanced Breast Cancer With A Germline Brca Mutation.

Related Experiment Video

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Niraparib Plus Aromatase Inhibitors for Hormone Receptor-Positive/HER2-Negative Advanced Breast Cancer with a

Laura Lema1, José Manuel Pérez-García2,3, Salvador Blanch4

  • 1Hospital Universitario 12 de Octubre, 28041 Madrid, Spain.

Cancers
|June 13, 2025

View abstract on PubMed

Summary
This summary is machine-generated.

Niraparib plus aromatase inhibitors show promising results for advanced breast cancer patients with BRCA mutations. This combination therapy met its primary endpoint, demonstrating significant clinical benefit and a manageable safety profile.

Keywords:
BRCA mutationHR+/HER2− breast canceradvanced breast canceraromatase inhibitorsniraparib

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Area of Science:

  • Oncology
  • Genetics
  • Pharmacology

Background:

  • Niraparib, a poly (adenosine diphosphate-ribose) polymerase inhibitor, demonstrates potential in treating advanced breast cancer with germline BRCA1/2 mutations.
  • Hormone receptor-positive (HR+)/HER2-negative advanced breast cancer often develops resistance to standard therapies, necessitating novel treatment strategies.

Purpose of the Study:

  • To evaluate the efficacy and safety of combining niraparib with aromatase inhibitors (AIs) in patients with HR+/HER2- advanced breast cancer.
  • Specifically assess outcomes in patients with germline BRCA1/2 mutations (cohort A) and explore outcomes in those with wild-type BRCA and homologous recombination deficiency (cohort B).

Main Methods:

  • The LUZERN trial was a multicenter, open-label, phase II clinical trial (NCT04240106).
  • Patients received niraparib (300 mg or 200 mg) in combination with an AI, having received ≤1 line of chemotherapy and 1-2 prior lines of endocrine therapy for advanced disease.
  • The primary endpoint was the clinical benefit rate (CBR) in cohort A (germline BRCA1/2 mutation carriers).

    • Main Results:

    • 14 patients were enrolled in cohort A; cohort B had no enrollments. The median follow-up was 16.7 months.
    • The CBR in cohort A was 46.2% (95% CI: 19.2-74.9), meeting the primary endpoint.
    • Median progression-free survival was 5.5 months (95% CI: 1.9-8.5), and median overall survival was 18.1 months (95% CI: 9.7-NE). The safety profile was consistent with known drug toxicities.

    Conclusions:

    • Niraparib combined with an AI shows encouraging antitumor activity in patients with AI-resistant HR+/HER2- advanced breast cancer and germline BRCA1/2 mutations.
    • The combination therapy demonstrated a manageable safety profile, supporting its potential as a treatment option for this patient population.