Ignite Creation Date:
2024-05-06 @ 2:11 PM
Last Modification Date:
2024-10-26 @ 1:26 PM
Study NCT ID:
NCT04240106
Status:
COMPLETED
Last Update Posted:
2024-02-16
First Post:
2020-01-14
Brief Title:
Niraparib Plus Aromatase Inhibitors for Luminal-likeHER2-ER and gBRCA or HDR Metastatic Breast Cancer LUZERN
Sponsor:
MedSIR
Organization:
MedSIR
Study Overview
Official Title:
MulticenterOpen-labelPhase II Clinical Trial to Evaluate the Efficacy and Safety of Niraparib Aromatase Inhibitors forHRHER2- 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-positiveHER2-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-positiveHuman 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-positiveHER2-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 N6 patients in the cohort A
Stage II N8 patients in the cohort A N9 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-positiveHER2-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 N6 patients in the cohort A
Stage II N8 patients in the cohort A N9 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:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2017-004323-72 | EUDRACT_NUMBER | None | None |