Study on New Combination of Low Dose Cyclophosphamide with Axatilimab and Retifanlimab for Treating Metastatic Triple Negative Breast Cancer

Inclusion Criteria

• Must have a confirmed diagnosis of metastatic or locally recurrent breast cancer that cannot be surgically removed and for which no standard treatments are available or effective.
• Must have triple negative breast cancer, defined as having low levels of estrogen and progesterone receptors and being HER2 negative, or have inflammatory breast cancer with specific hormone receptor levels.
• At least one week must have passed since any previous chemotherapy or radiation therapy.
• Must be 18 years or older.
• Must have at least one tumor that can be measured by scans.
• Must be in relatively good health, with a performance status score of 2 or better.
• Must have adequate blood cell counts and organ function, including:
  • Neutrophil count of at least 1,000/mcL
  • Hemoglobin level above 9 mg/dL
  • Platelet count above 100,000/mcL
  • Normal liver function tests, unless liver metastases are present.
  • Creatinine clearance of at least 30 mL/min.
• Must be able to understand and sign a consent form.
• Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study.
• Men must agree to use effective contraception during the study and for four months after.

Exclusion Criteria

• Cannot have unresolved side effects from previous cancer treatments, except for hair loss.
• Cannot have a history of lung disease or active lung inflammation.
• Cannot have active autoimmune diseases requiring high doses of steroids or immunosuppressive drugs.
• Cannot have allergies to the study drugs.
• Cannot have uncontrolled medical conditions or serious illnesses that could be worsened by the study.
• Cannot have active infections requiring treatment within 14 days before starting the study.
• Cannot have active hepatitis B or C infections unless they are well-controlled.
• Cannot have HIV unless on effective treatment with an undetectable viral load.
• Cannot have psychiatric or social issues that would prevent following the study requirements.
• Cannot be pregnant or breastfeeding.
• Cannot have other active cancers, except for certain skin or cervical cancers.
• Cannot have untreated brain metastases unless they have been treated and are stable.
• Cannot have heart disease or significant heart events within six months before starting the study.
• Cannot have abnormal heart rhythms unless controlled.
• Cannot be participating in another clinical trial or taking investigational drugs.