MedTrace Logo

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

NCT04240106 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2024-02-16

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Niraparib

Niraparib orally daily beginning on Day 1 and continuing through Day 28 of every 28-day cycle.

DRUG

Aromatase Inhibitors

Aromatase Inhibitors beginning on Day 1 and continuing through Day 28 of every 28-day cycle.

Sponsors & Collaborators

Principal Investigators

  • Antonio Llombart · MedSIR

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-15
Primary Completion
2022-11-17
Completion
2023-11-17

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04240106 on ClinicalTrials.gov