Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-29 @ 11:11 PM
Study NCT ID:
NCT03025035
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-02
First Post:
2017-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pembrolizumab in Combination With Olaparib in Advanced BRCA-mutated or HDR-defect Breast Cancer
Sponsor:
Yuan Yuan
Organization:
Study Overview
Official Title:
Open Label, Phase II Pilot Study of Immune Checkpoint Inhibition With Pembrolizumab in Combination With PARP Inhibition With Olaparib in Advanced BRCA-mutated or HDR-defect Breast Cancers
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-11
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:
This trial will evaluate the use of immunotherapy and PARP inhibition in a population with incurable advanced breast cancer associated with a germline BRCA mutation or HDR-defect. The main objective is to examine overall response rate of pembrolizumab (immunotherapy) in combination with Olaparib (PARP inhibitor) in advanced BRCA-mutated or Homology-directed repair (HDR)-defect breast cancer.
Detailed Description:
There are two BRCA genes, BRCA1 and BRCA2, and they play a role in protecting cells from cancer. HDR-defect is another type of gene mutation that can contribute to development and progression of cancer. If one of these genes is mutated, cells may rapidly change and divide, which can lead to cancer. Pembrolizumab is a drug that works with the immune system to target the tumor (immunotherapy). The investigators want to know if combining pembrolizumab and Olaparib therapy will be able to reduce the size and amount of cancer cells with fewer side effects than standard treatment by targeting the tumor. This research study is designed to test the investigational use of pembrolizumab and Olaparib in breast cancer.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
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?: