Printed from Voxsanity (voxsanity.com.au) — NCT06959537 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 1 Breast Cancer Trial, Recruiting
NCT06959537
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
- People who have been diagnosed with cancer (confirmed by lab testing of tissue or cells) that has spread or come back in a way that cannot be surgically removed, and where standard treatments no longer exist or are no longer working.
- People with triple-negative breast cancer (not inflammatory type) confirmed by lab testing, where the tumour tests negative for oestrogen receptor, progesterone receptor, and HER2 protein (using specific medical guidelines).
- People with inflammatory breast cancer confirmed by internationally recognised criteria, with low levels of oestrogen and progesterone receptors.
- People who finished chemotherapy or radiation therapy at least 1 week before joining the trial.
- People aged 18 years or older.
- People who have at least one tumour that can be measured using standard imaging criteria.
- People who are reasonably active and able to care for themselves, based on a standard medical fitness scale (confirm with trial site).
- People whose blood counts, liver, and kidney function fall within acceptable ranges as determined by blood tests (confirm with trial site for specific values).
- People who are able to understand the study and are willing to sign a written consent form.
- People who are not cognitively impaired (the trial does not enrol participants with cognitive impairment).
- Women who could become pregnant must have a negative pregnancy blood test within 72 hours before the first dose of study medication.
- Women who could become pregnant must be willing to use highly effective contraception throughout the study, or must already be surgically sterile or abstinent. This applies to female participants from the start of menstruation (as early as age 8) up to age 55, unless they meet specific exemptions such as being postmenopausal, having had a hysterectomy or bilateral removal of ovaries, having ovarian failure confirmed by hormone testing after whole pelvic radiation, or having had a surgical sterilisation procedure.
- Men participating in the trial must also agree to use adequate contraception before, during, and for 4 months after completing all study treatment.
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People who have not yet recovered from side effects of previous cancer treatments, where those side effects are still significant (above a mild level), except for hair loss. Note: people with certain stable, long-standing mild-to-moderate side effects from prior treatment may still be considered (confirm with trial site).
- People with a history of, or currently active, scarring or inflammation of the lung tissue (interstitial lung disease or non-infectious pneumonitis).
- People with an active autoimmune disease that requires high-dose immune-suppressing medications (such as corticosteroids above a certain dose or other immunosuppressant drugs) within the 2 years before starting the trial.
- People with a history of serious allergic reactions to drugs chemically or biologically similar to the study medications cyclophosphamide, axatilimab, or retifanlimab.
- People with other serious uncontrolled illnesses, or physical or psychiatric conditions that the trial doctor considers unsafe for participation.
- People who have an active infection requiring antibiotic, antifungal, or antiviral medication within 14 days before starting the trial.
- People with a known active Hepatitis B or Hepatitis C infection (testing is required; specific definitions apply — confirm with trial site).
- People with a history of chronic Hepatitis B where the virus is still detectable in the blood, unless it is undetectable on suppressive treatment.
- People with a history of Hepatitis C who have not been treated and cured (those currently on treatment may still be considered if the virus is undetectable — confirm with trial site).
- People known to have HIV, unless they are on effective HIV treatment with an undetectable viral load within the past 6 months.
- People with psychiatric illness or personal circumstances that would make it difficult to follow the trial requirements.
- Women who are pregnant are excluded due to potential harm to the unborn baby.
- People who have had another cancer in the past, except for certain cured cancers (non-melanoma skin cancer, cured cervical carcinoma in situ, and cured thyroid cancer).
- People with active cancer spread to the brain that still requires treatment. People who have already had brain metastases treated may be considered, provided follow-up imaging shows no signs of the cancer growing back in the brain.
- People with known cancer spread to the membranes surrounding the brain and spinal cord, confirmed by imaging or cell testing.
- People with significant heart disease history may not be eligible; a heart function assessment is required, and only those meeting a specific heart function threshold (confirm with trial site) may be considered.
- People with an abnormal heart electrical tracing (ECG) that the doctor considers clinically significant, or with a specific type of heart rhythm abnormality above a defined threshold (confirm with trial site for details). People with medically controlled heart rhythm problems may still be considered.
- People who have had a significant heart event within 6 months before starting the trial, such as a heart attack, severe chest pain, heart failure, a procedure on the heart or blood vessels, a mini-stroke, or a blood clot in the lungs.
- People who are currently participating in another clinical trial involving an experimental treatment.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Contact this trial
Principal Investigator: Bora Lim, MD, M.D. Anderson Cancer Center
Phone: (713) 745-0689
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Status
Recruiting
Phase
Phase 1
Sponsor
Registry
ClinicalTrials.gov
Start date
13 August 2025
Est. completion
31 January 2027
Where this trial is recruiting
🇺🇸 United States
Primary endpoints
Safety and Adverse Events (AEs)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 30 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.