Ignite Creation Date:
2025-12-26 @ 2:41 PM
Ignite Modification Date:
2025-12-26 @ 2:41 PM
Study NCT ID:
NCT04240106
Status:
COMPLETED
Last Update Posted:
2024-02-16
First Post:
2020-01-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Niraparib Plus Aromatase Inhibitors for Luminal-like(HER2-,ER+) and gBRCA or HDR+ Metastatic Breast Cancer (LUZERN)
Sponsor:
MedSIR
Organization:
Study Overview
Official Title:
Multicenter,Open-label,Phase II Clinical Trial to Evaluate the Efficacy and Safety of Niraparib + Aromatase Inhibitors for(HR)+/(HER2)-, MBC With Either Germline BRCA-mutated or Germinal BRCA-wildtype and Homologous Recombination Deficiency
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LUZERN
Brief 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.
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.
Detailed Description:
This is a Multicenter, Open-label, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Niraparib plus Aromatase Inhibitors for Hormone Receptor (HR)-positive/Human Epidermal Growth Factor Receptor 2 (HER2)-negative Metastatic Breast Cancers with either Germline BRCA-mutated or Germinal BRCA-wild-type and Homologous Recombination Deficiency (HRD).
The main objetive is to assess 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.
Upon meeting all selection criteria, patients enrolled in the study will receive the combination of niraparib orally (according to baseline criteria described in Table 4), once daily, flat- fixed, continuously in 28-day cycles and AI that must be identical to the last AI-containing regimen.
A total of 23 patients will be recruited as follows:
* Stage I: N=6 patients in the cohort A;
* Stage II: N=8 patients in the cohort A; N=9 patients in the exploratory cohort B
The total duration of the study period is 36 months follow until 5 years of follow up.
The main objetive is to assess 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.
Upon meeting all selection criteria, patients enrolled in the study will receive the combination of niraparib orally (according to baseline criteria described in Table 4), once daily, flat- fixed, continuously in 28-day cycles and AI that must be identical to the last AI-containing regimen.
A total of 23 patients will be recruited as follows:
* Stage I: N=6 patients in the cohort A;
* Stage II: N=8 patients in the cohort A; N=9 patients in the exploratory cohort B
The total duration of the study period is 36 months follow until 5 years of follow up.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2017-004323-72 | EUDRACT_NUMBER | None | View |