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Phase Ib Study of Axatilimab in Combination With Olaparib in BRCA1/2 and PALB2- Associated Metastatic HER2-negative Breast Cancer

StatusRecruiting
PhasePhase 1
Started2024-08-13
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 8 months later Sep 1, 2026 → May 1, 2027
See other at-risk trials from Dana-Farber Cancer Institute

Amendment history

2026-08-31
Study Status, Oversight, Contacts/Locations v4
Primary completion pushed: 2026-09-01 → 2027-05-01
Study sites3→2
2025-08-18
Study Identification, Study Status, Contacts/Locations v3
Study sites2→3
Study titlerevised
Phase Ib Study of Axatilimab in Combination withWith Olaparib in BRCA1/2 and PALB2- Associated Metastatic HER2-negative Breast Cancer
2024-08-29
Study Identification, Study Status, Oversight, Contacts/Locations, IPDSharing v2
Start dateestimated 2025-08→confirmed 2024-08-13
Study sitescontacts updated at 2 of 2 sites
Study titlerevised
Phase Ib Study of Axatilimab in Combination Withwith Olaparib in BRCA1/2 and PALB2- Associated Metastatic HER2-negative Breast Cancer
2024-08-22
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start date2025-07→2025-08
Study sitesdetails revised at 2 of 2 sites
2024-06-28
Original filing
This research is being done to evaluate the safety and tolerability of the new drug, axatilimab, in combination with olaparib (a standard of care treatment) in Breast Cancer 1/2 genes (BRCA 1/2) and PALB2 associated HER2-negative metastatic breast cancer. The names of the study drugs involved in this study are: * Axatilimab (a type of antibody) * Olaparib (a type of PARP inhibitor)
Trial Details
NCT Number NCT06488378
Lead Sponsor Dana-Farber Cancer Institute
Collaborators: Incyte Corporation
Conditions Breast Cancer, PALB2-Mutated Breast Carcinoma, HER2-negative Breast Cancer, BRCA1 Mutation, BRCA2 Mutation
Enrollment 20 participants
Start Date 2024-08-13
Primary Completion 2027-05-01 (estimated)
Study Completion 2029-03-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-02