Niraparib Plus Aromatase Inhibitors for Luminal-like(HER2-,ER+) and gBRCA or HDR+ Metastatic Breast Cancer (LUZERN)

Sponsor
MedSIR
Study ID
NCT04240106
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Niraparib — DRUG
    Niraparib orally daily beginning on Day 1 and continuing through Day 28 of every 28-day cycle.
  • Aromatase Inhibitors — DRUG
    Aromatase Inhibitors beginning on Day 1 and continuing through Day 28 of every 28-day cycle.

Study Details

This study evalues the efficacy -as determined by the clinical benefit rate (CBR)- of niraparib in combination with AIs in unresectable locally advanced or metastatic HR-positive/HER2-negative breast cancer patients harboring either gBRCAms or gBRCAwt and HRD. The planned number of patients is 23. Investigational product is Niraparib and will be administered daily continuously in 28-day cycles plus aromatase Inhibitors. Total study duration is 36 months and until 5 years of follow up.

Key Dates

Start date
Jun 15, 2020
Status verified
Mar 2023
Primary completion
Nov 17, 2022
Completion
Nov 17, 2023

Study Design

Enrollment
14 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Niraparib in combination with Aromatase Inhibitors
    Upon meeting all selection criteria, patients enrolled in the study will receive the combination of niraparib orally, once daily, flat- fixed, continuously in 28-day cycles plus aromatase Inhibitors.

Primary Outcome Measure

Clinical benefit rate (CBR) of niraparib in combination with AIs in unresectable locally advanced or metastatic HR-positive/HER2-negative breast cancer patients harboring either gBRCAms or gBRCAwt and HRD [ Time Frame: Baseline up to 24 weeks ]

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