Phase Ib Study of Axatilimab in Combination With Olaparib in BRCA1/2 and PALB2- Associated Metastatic HER2-negative Breast Cancer
Dana-Farber Cancer Institute
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)
Description
This is a non-randomized, open-label, proof-of-concept phase 1 study to evaluate the safety and tolerability of a drug known as Axatilimab in combination with the drug Olaparib in BRCA1/2 and PALB2 associated HER2-negative breast cancer. The U.S. Food and Drug Administration (FDA) has not approved axatilimab as a treatment for any disease. The FDA has approved olaparib as a treatment option for BRCA1/2 and PALB2 associated HER2-negative breast cancer, and it is considered standard of care for those types of breast cancer. The FDA has approved olaparib for metastatic (breast cancer that has s…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participants must have histologically or cytologically confirmed metastatic or unresectable HER2 negative breast cancer, including HER2 low (IHC 2+/ISH-, IHC 1+). Any ER and PR expressions are permitted but must be known. Patients with hormone receptor (HR) positive disease, defined by either ER and/or PR positivity, must have progressed or are intolerant to all available endocrine therapy regimens, or not candidates to further endocrine therapy-based approaches. * Documented germline or somatic mutation in BRCA1, BRCA2, or germline mutation in PALB2 that is predicted to…
Interventions
- DrugAxatilimab
Humanized immunoglobulin G (IgG)4 monoclonal antibody, 1.3 mL sterile, preservative free glass vials, via intravenous (into the vein) infusion per protocol.
- DrugOlaparib
Inhibitor of poly ADP ribose polymerase (PARP)1-3, 100 or 150 mg tablet, taken orally per standard of care.
Locations (3)
- Beth Israel Deaconess Medical CenterBoston, Massachusetts
- Brigham and Women's HospitalBoston, Massachusetts
- Dana-Farber Cancer InstituteBoston, Massachusetts