OncoMatch/Clinical Trials/NCT06959537
A Phase Ib Study of Novel Combination (New) of Low Dose Oral CyclophoSphamide (s) to Potentiate Axatilimab (A) + Retifanlimab (R) in Treating Metastatic Triple Negative Breast Cancer (TNBC)
Is NCT06959537 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Cyclophosphamide and Axatilimab (SNDX-6352) for breast cancer.
Treatment: Cyclophosphamide · Axatilimab (SNDX-6352) · Retifanlimab — The goal of this clinical research study is to find the best dose of the drugs cyclophosphamide and axatilimab that can be given in combination with the standard dose of retifanlimab to patients with metastatic TNBC.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 expression <1% (<1%)
ER<1%
Required: PR (PGR) expression <1% (<1%)
PR<1%
Required: HER2 (ERBB2) negative per ASCO CAP 2018 guideline (negative)
HER2 negative per ASCO CAP 2018 guideline
Required: ESR1 expression <20% (<20%)
IBC confirmed according to international consensus criteria that is ER<20%
Required: PR (PGR) expression <20% (<20%)
IBC confirmed according to international consensus criteria that is PR<20%
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Lab requirements
Blood counts
absolute neutrophil count ≥ 1,000/mcL; hemoglobin >9 mg/dL; platelets ≥ 100,000/mcL
Kidney function
Creatinine clearance ≥30 mL/min (measured by the Cockcroft-Gault equation)
Liver function
total bilirubin ≤ institutional ULN; AST(SGOT)/ALT(SGPT) ≤ 3x institutional ULN; ≤ 5x ULN if confirmed liver metastasis and elevation is deemed to be directly due to metastasis
Cardiac function
NYHA class 2B or better, EF greater than 45%; Qtc interval ≤ 480 milliseconds (corrected by Fridericia or Bazett formula); medically controlled arrhythmias allowed
Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better, and EF greater than 45% despite best supportive care. Patients with a history or presence of screening ECG test that is clinically significantly abnormal in the investigator's opinion. Patients with a prolonged Qtc interval > 480 milliseconds (corrected by Fridericia or Bazett formula are excluded, but medically controlled arrhythmias are allowed.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- The University of Texas M. D. Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify