Ignite Creation Date:
2024-05-06 @ 6:19 PM
Last Modification Date:
2024-10-26 @ 2:46 PM
Study NCT ID:
NCT05629429
Status:
RECRUITING
Last Update Posted:
2024-01-17
First Post:
2022-11-02
Brief Title:
Olaparib Maintenance Therapy in Metastatic Breast Cancer
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
Olaparib Maintenance Therapy in Patients With Metastatic Breast Cancer Following DNA-damaging Based Chemotherapy
Status:
RECRUITING
Status Verified Date:
2024-01
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:
None
Brief Summary:
Olaparib a PARP inhibitor is proven as an effective therapy for germline BRCA12-mutated breast cancer however the therapeutic efficacy for somatic mutation in BRCA12 or genes of homologous recombination DNA repair is unclear Maintenance of Oalaprib can delay the disease progression in patients with BRCA12 mutated advanced ovarian cancer after treatment with platinum based chemotherapy The investigators design a phase 2 study to evaluate the efficacy of maintenance of Olaparib in patients with metastatic breast cancer The investigators enroll patients with metastatic ERHer2- or triple-negative breast cancer Patients who are chemotherapy-naïve or prior 1-line chemotherapy are eligible for screening All eligible patients will receive 4 cycles of platinum based chemotherapy Gene test will be performed on their breast tumor If patients have mutation of HR genes and at least stable disease after platinum based chemotherapy they will be randomized to treatment arm Olaparib maintenance or control arm continuation of chemotherapy The primary end-point is progression-free survival and the secondary end-point is to assess the response rate overall survival and quality of life
Detailed Description:
None
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