Printed from Voxsanity (voxsanity.com.au) — NCT07458113 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 2 Breast Cancer Trial, Not Yet Recruiting
NCT07458113
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 of any sex or gender who are at least 18 years old at the time of signing the consent form.
- People who cannot consent for themselves may still be considered if a legally authorised representative is available to provide consent on their behalf.
- People who have been diagnosed with metastatic triple-negative breast cancer, confirmed by laboratory testing of tissue, where the cancer tests negative for oestrogen receptors, progesterone receptors, and HER2.
- People who have either newly diagnosed, untreated brain metastases (cancer that has spread to the brain), or brain metastases that have continued to grow after previous local treatments such as surgery or radiation therapy.
- People who have at least one measurable area of cancer in the brain, defined as a contrast-enhancing lesion at least 10 mm at its longest point, visible on two or more scan slices, and at least 5 mm wide in the perpendicular direction (confirm with trial site for exact imaging requirements).
- People for whom the treating doctor does not consider immediate surgery or radiation therapy to the brain to be clinically necessary.
- People who do not have confirmed cancer spread to the lining of the brain and spinal cord (leptomeningeal disease), based on fluid testing — though imaging findings that suggest this may be present are allowed if the fluid test is negative.
- People with a performance status score of 0 or 1 on the ECOG scale, meaning they are fully active or have only minor restrictions on physical activity (confirm with trial site).
- People who have received any number of prior cancer treatments, with no restriction on how many.
- People who have previously been treated with a type of drug called an antibody-drug conjugate, either as a standard treatment or as part of another research study.
- People who are expected to live for at least three months, based on the treating doctor's assessment.
- People who have waited the required time since their last treatment before starting the study — including at least four weeks after major surgery or radiation therapy, at least three weeks after chemotherapy or antibody-based cancer therapy, at least two weeks after targeted or small molecule drugs, and more than 30 days after receiving a live vaccine (confirm with trial site for full washout period details).
- People who are able to provide an archived tumour tissue sample or a recently taken tissue biopsy, if one is available — fresh tissue collection is not required.
- People whose blood and organ function test results meet the required levels, collected within 72 hours before starting the study treatment (confirm with trial site for specific laboratory value thresholds).
- People who are willing and able to follow all study procedures, attend required tests, and meet other study requirements.
- People living with HIV may be considered if their HIV is well controlled on antiretroviral therapy, their immune cell count and viral load meet specific thresholds, they have had no serious HIV-related infections in the past 12 months, and their treatment regimen has been stable for at least four weeks (confirm with trial site for full HIV-related requirements).
- People who are hepatitis B surface antigen positive may be considered if they have been on hepatitis B antiviral therapy for at least four weeks or have an undetectable hepatitis B viral load before joining.
- People with a history of hepatitis C infection may be considered if the hepatitis C viral load is undetectable at screening.
- People who agree to follow specific pregnancy prevention and contraception requirements during treatment and for 210 days after the last dose, including using at least one highly effective method of contraception if they are of childbearing potential, and ensuring partners of childbearing potential also use contraception for at least 120 days after the last dose.
- People who are of childbearing potential must have a negative pregnancy blood test within 72 hours before the first dose and agree to further pregnancy testing during the study if required.
- People must agree not to donate or freeze eggs or sperm for reproductive purposes during the study and for 210 days after the last dose.
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 previously been treated with the study drug, sacituzumab tirumotecan.
- People with a known allergy or sensitivity to sacituzumab tirumotecan or any of its ingredients.
- People who are currently receiving other cancer treatments at the same time, including chemotherapy, targeted therapy, immunotherapy, antibody therapy, retinoids, or anti-cancer hormonal therapy — with the exception of bone-protective treatments such as denosumab or bisphosphonates.
- People with a history of uncontrolled seizures (more than two seizures in the 28 days before joining), significant nervous system conditions, or a psychiatric condition that the treating doctor considers serious enough to affect safe participation in the study.
- People with severe lung problems caused by an ongoing lung illness.
- People who are pregnant or breastfeeding.
- People who need ongoing high-dose steroid treatment (more than 8 mg of dexamethasone per day taken by mouth or through a vein) or other immune-suppressing medications, except when used to manage side effects — inhaled steroids and joint injections are permitted.
- People who have a history of severe dry eye syndrome, severe eyelid gland disease, severe eyelid inflammation, or a serious corneal condition that prevents or delays healing of the surface of the eye.
- People with serious, uncontrolled heart or blood vessel conditions in the six months before starting the study, including severe heart failure, unstable chest pain, heart attack, uncontrolled heart rhythm problems, a prolonged electrical interval on a heart tracing (QTcF greater than 480 ms), or other significant cardiovascular or stroke-related conditions.
- People who are currently taking part in the active treatment phase of another clinical trial.
- People who have another cancer that is currently spreading through the body.
- People who have an active infection that requires treatment with systemic (whole-body) medication.
- People who have any condition, treatment history, abnormal test result, or other circumstance that the treating doctor believes could interfere with the study results or make participation not in the person's best interest.
- People who have had major surgery or a significant injury within four weeks before the first dose of study treatment.
- People who currently have grade 3 or higher inflammation of the lungs or lung scarring (confirm with trial site for grading details).
- People who have received a live or live-attenuated vaccine within 30 days before the first dose — vaccines using killed virus are allowed.
- People who are currently taking a strong inducer or inhibitor of a liver enzyme called CYP3A4 that cannot be stopped for the duration of the study treatment, with a required two-week washout period before starting.
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: Adriana Kahn, MD, Yale University
Phone: 773-369-6904
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
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Trial details
Status
Not Yet Recruiting
Phase
Phase 2
Sponsor
Registry
ClinicalTrials.gov
Start date
1 May 2026
Est. completion
1 May 2028
Where this trial is recruiting
🇺🇸 United States
Primary endpoints
Intracranial response rate determined by Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) in patients with metastatic triple-negative breast cancer and brain metastases.
Can't join this trial?
Data last synced from ClinicalTrials.gov: 13 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.