Actively Recruiting
Phase Ib Study of Axatilimab in Combination With Olaparib in BRCA1/2 and PALB2- Associated Metastatic HER2-negative Breast Cancer
Led by Dana-Farber Cancer Institute · Updated on 2025-08-22
20
Participants Needed
3
Research Sites
237 weeks
Total Duration
On this page
Sponsors
D
Dana-Farber Cancer Institute
Lead Sponsor
I
Incyte Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Phase Ib Study of Axatilimab in Combination With Olaparib in BRCA1/2 and PALB2- Associated Metastatic HER2-negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed metastatic or unresectable HER2 negative breast cancer, including HER2 low (IHC 2+/ISH-, IHC 1+)
- Any ER and PR expressions permitted but must be known; hormone receptor positive patients must have progressed or be intolerant to all endocrine therapies or not candidates for further endocrine therapy
- Documented germline or somatic mutation in BRCA1, BRCA2, or germline mutation in PALB2 predicted to be deleterious
- Evaluable or measurable disease per RECIST 1.1 criteria; if only measurable disease was previously irradiated, must show evidence of progression
- No more than 2 prior lines of cytotoxic chemotherapy for metastatic disease
- Age 18 years or older
- ECOG performance status of 0 to 2
- Adequate organ and marrow function including leukocytes ≥ 3000/mcL, neutrophils ≥ 1.5 x 10^9/L, platelets ≥ 100 x 10^9/L, bilirubin ≤ 1.5x ULN, AST/ALT ≤ 2.5x ULN or ≤ 5x ULN with liver metastases, creatinine clearance ≥ 51 mL/min
- If HBsAg positive, must have received antiviral therapy for at least 4 weeks and have undetectable viral load
- If history of HCV infection, must have undetectable viral load and completed curative antiviral therapy at least 4 weeks prior
- HIV-infected participants must have well-controlled infection with CD4+ count ≥ 350 cells/mm3 and viral suppression for at least 12 weeks
- Ability to swallow and retain oral medication
- Patients with treated CNS metastases may participate if disease outside CNS is present, no CNS progression, at least 2 weeks since radiotherapy, and no significant corticosteroid escalation
- Prior or concurrent malignancies allowed if they do not interfere with safety or efficacy assessments
- Female participants must be postmenopausal or have a negative pregnancy test and agree to use adequate contraception if of child-bearing potential
- Willingness to undergo 3 research biopsies unless unsafe or infeasible
- Ability and willingness to sign informed consent
You will not qualify if you...
- Clinical progression on or within 12 months of prior PARP inhibitor treatment
- Previous treatment with CSF1R antibody
- Systemic chemotherapy, immune therapy, or investigational therapy within 3 weeks of starting study treatment; endocrine therapy must be stopped at least 7 days prior
- Unrecovered adverse events from prior anti-cancer therapy greater than Grade 1 except alopecia
- History of allergic reactions to drugs similar to axatilimab or olaparib
- Use of medications that are strong or moderate CYP450 inhibitors or inducers including CYP3A inhibitors/inducers
- QTcF interval >470 msec on screening ECG
- History or features of myelodysplastic syndrome or acute myeloid leukemia
- Inability to swallow oral medication or gastrointestinal disorders interfering with absorption
- Uncontrolled illness including uncontrolled hypertension, active infection, symptomatic heart failure, unstable angina, cardiac arrhythmia, or psychiatric/social conditions limiting compliance
- History or evidence of pneumonitis or interstitial lung disease
- Known active or latent tuberculosis
- Major surgery within 28 days prior to starting study treatment
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
Actively Recruiting
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
F
Filipa Lynce, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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