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NCT06488378 · ClinicalTrials.gov registry record · Phase 1
Phase Ib Study of Axatilimab in Combination With Olaparib in BRCA1/2 and PALB2- Associated Metastatic HER2-negative Breast Cancer
A Phase 1 study of Breast Cancer and HER2-Negative Breast Cancer, sponsored by Dana-Farber Cancer Institute.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 3
- Study locations
NCT06488378: Recruiting Phase 1 study of Breast Cancer and HER2-Negative Breast Cancer, sponsored by Dana-Farber Cancer Institute.
NCT06488378 is a Phase 1 study of Breast Cancer and HER2-Negative Breast Cancer that is actively recruiting participants, run by Dana-Farber Cancer Institute. The registered enrollment target is 20 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06488378, a Phase 1 study of Breast Cancer and HER2-Negative Breast Cancer, is actively recruiting participants, sponsored by Dana-Farber Cancer Institute.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 3
- Study locations
Study Summary
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)
Primary Outcome
MTD is determined by Bayesian optimal interval (BOIN) design, where the target toxicity rate for the MTD is 0.25 and the maximum sample size is 20.
Conditions Studied
Interventions
- DRUG Olaparib
- DRUG Axatilimab
Study Locations (3)
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
- Brigham and Women's Hospital - Boston
- Dana-Farber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-08-13 |
| Est. Completion | 2029-03-01 |
| Phase | Phase 1 |
What NCT06488378 shows while recruiting
NCT06488378 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower).
The record links to 5 conditions, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Olaparib is the first listed.
NCT06488378 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06488378 about?
NCT06488378 is a clinical study titled "Phase Ib Study of Axatilimab in Combination With Olaparib in BRCA1/2 and PALB2- Associated Metastatic HER2-negative Breast Cancer". 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 th...
What is the current status of trial NCT06488378?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2024-08-13. Estimated completion is 2029-03-01.
What conditions does trial NCT06488378 study?
This clinical trial studies the following conditions: Breast Cancer, HER2-Negative Breast Cancer, BRCA1 Mutation, BRCA2 Mutation, PALB2-Mutated Breast Carcinoma.
What interventions are being tested in trial NCT06488378?
The interventions under investigation include: Olaparib (DRUG), Axatilimab (DRUG).
Who is sponsoring clinical trial NCT06488378?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06488378 being conducted?
This trial has 3 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06488378's enrollment target sits among peer trials
20 1079th of 1224 higher than 112 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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