Experimental cocktail aims to outsmart Hard-to-Treat breast cancer
NCT ID NCT06959537
First seen Jun 25, 2026 · Last updated Jul 31, 2026 · Updated 3 times
Summary
This early-phase trial is testing a new combination of three drugs—cyclophosphamide, axatilimab, and retifanlimab—in people with metastatic triple negative breast cancer that has stopped responding to standard treatments. The main goal is to find the safest dose of the new combination. About 24 participants will be enrolled at M.D. Anderson Cancer Center.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- cyclophosphamide, axatilimab, and retifanlimab
- What this could lead to
- If this works, it could point toward a new treatment option for people with metastatic triple negative breast cancer who have run out of standard options.
- What could go wrong
- This is a very early phase 1 trial with only 24 people, focused on finding the right dose and checking safety. It is too soon to know if the combination will actually shrink tumors or improve survival.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients must have histologically confirmed malignancy that is metastatic or locally recurrent unresectable and for which standard curative or palliative measures do not exist or are no longer effective. * Patients must have histologically or cytologically confirmed non-IBC triple negative breast cancers, defined here as ER\<1%, PR\<1% and HER2 negative per ASCO CAP 2018 guideline. OR * Inflammatory breast cancer (IBC) confirmed according to international consensus criteria that is ER\<20% and PR\<20%. * At least 1 week since prior chemotherapy or radiation therapy * Age .18 years. * Has at least one measurable lesion per RECIST 1.1 * ECOG performance status . 2 (Karnofsky . 60%,). * Patients must have adequate organ and marrow function as defined below: * absolute neutrophil count . 1,000/mcL * hemoglobin \>9 mg/dL * platelets . 100,000/mcL * total bilirubin . institutional upper limit of normal (ULN) * AST(SGOT)/ALT(SGPT) . 3 \~ institutional ULN; . 5 \~ institutional ULN if confirmed liver metastasis and elevation is deemed to be directly due to metastasis. * Creatinine clearance .30 mL/min (measured by the Cockcroft-Gault equation\*). * Ability to understand and the willingness to sign a written informed consent * . Cognitively impaired subjects will not be enrolled in this study. * Negative serum pregnancy test within 72 hours of receiving the first dose of the study medication for women of childbearing potential as per institutional guidelines. * Subjects of childbearing potential must be willing to use highly effective birth control methods or be surgically sterile or abstain from heterosexual activity for the course of the study. Women must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following: * Postmenopausal (no menses in greater than or equal to 12 consecutive months). * History of hysterectomy or bilateral salpingo-oophorectomy. * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy). * History of bilateral tubal ligation or another surgical sterilization procedure. * Approved methods of birth control are as follows: Hormonal contraception (i.e., birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. * Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of all study drug administration. Exclusion Criteria: * Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 1) except for alopecia. Note: Subjects may be enrolled with chronic, stable Grade 2 toxicities (defined as no worsening to \> Grade 2 for at least 3 months prior to \[enrollment/Cycle 1 Day 1\] and managed with standard of care treatment) that the investigator deems related to previous anticancer therapy, including: Chemotherapyinduced neuropathy, Fatigue, Residual toxicities from prior IO treatment: Grade 1 or Grade 2 endocrinopathies which may include: Hypothyroidism/hyperthyroidism, Type I diabetes, Hyperglycemia, Adrenal insufficiency, Adrenalitis and Skin hypopigmentation (vitiligo) * Patients with a history of interstitial lung disease (past or current) or active, non-infectious pneumonitis. * Patients with active autoimmune disease requiring systemic immunosuppression with corticosteroids (\> 10 mg/day of prednisone or equivalent) or immunosuppressive drugs within 2 years before the first dose of study treatment. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to cyclophosphamide, axatilimab, retifanlimab used in study. * Patients with uncontrolled intercurrent illness. Medical history or complication considered inappropriate for participation in the study, or a serious physical or psychiatric disease, the risk of which may be increased by participation in the study in the investigator's opinion. * Patients with active infections requiring systemic antibiotics or antifungal or antiviral treatment within 14 days of C1D1 study treatment. * Patients with known active Hepatitis B or Hepatitis C infection. Testing is required to establish eligibility. Active Hepatitis B infection is defined as a positive Hepatitis B surface antigen and positive Hepatitis B core antibody test. Active Hepatitis C infection is defined assay. * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. * Patients with known HIV infection, defined as positive for HIV1/2 antibodies. Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. * Patients with psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant women are excluded from this study due to potential for teratogenic or abortifacient effects. * Patients who are cancer survivors other than cured non-melanomatous skin cancer or cured cervical carcinoma in situ and thyroid cancer will be excluded from the study as other cancers can recur. * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. * Patients with active brain metastasis if treatment is warranted. Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)- directed therapy shows no evidence of progression. * Patients with known leptomeningeal disease, defined as unequivocal imaging or cytologyproven disease. * 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 cae. * 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. * Patients with a history of significant cardiac event within 6 months of C1D1. Significant cardiac events include baseline NYHA class III/IV cardiac disease, acute myocardial infarction, severe/unstable angina, cardiomyopathy, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, critical conduction delay, transient ischemic attack or pulmonary embolism. * Patients who are receiving any other investigational agents.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The University of Texas M. D. Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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