OncoMatch/Clinical Trials/NCT06488378
Phase Ib Study of Axatilimab in Combination With Olaparib in BRCA1/2 and PALB2- Associated Metastatic HER2-negative Breast Cancer
Is NCT06488378 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Axatilimab and Olaparib for breast cancer.
Treatment: Axatilimab · Olaparib — 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)
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: BRCA1 germline or somatic mutation predicted to be deleterious or suspected deleterious
Documented germline or somatic mutation in BRCA1 ... that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function)
Required: BRCA2 germline or somatic mutation predicted to be deleterious or suspected deleterious
Documented germline or somatic mutation in ... BRCA2 ... that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function)
Required: PALB2 germline mutation predicted to be deleterious or suspected deleterious
Documented ... germline mutation in PALB2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: PARP inhibitor (olaparib)
Clinical progression on a PARP inhibitor, or within 12 months of receipt of a PARP inhibitor, including but not limited to olaparib
Cannot have received: CSF1R antibody
Any previous treatment with CSF1R antibody
Lab requirements
Blood counts
leukocytes ≥ 3000/mcL; absolute neutrophil count ≥ 1.5 x 10^9/L; platelets ≥ 100 x 10^9/L
Kidney function
Creatinine clearance ≥ 51 mL/min (using Cockcroft-Gault equation)
Liver function
total bilirubin ≤ 1.5x institutional ULN; AST(SGOT)/ALT(SGPT) ≤ 2.5x × institutional ULN or ≤5 × institutional ULN for participants with documented liver metastases
Participants must meet the following organ and marrow function as defined below: * leukocytes ≥ 3000/mcL * absolute neutrophil count ≥ 1.5 x 109/L * platelets ≥ 100 x 109/L * total bilirubin ≤ 1.5x institutional upper limit of normal (ULN) * AST(SGOT)/ALT(SGPT) ≤ 2.5x × institutional ULN or ≤5 × institutional ULN for participants with documented liver metastases * Creatinine clearance ≥ 51 mL/min (using Cockcroft-Gault equation)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Beth Israel Deaconess Medical Center · Boston, Massachusetts
- Brigham and Women's Hospital · Boston, Massachusetts
- Dana-Farber Cancer Institute · Boston, Massachusetts
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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