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Phase 2 Breast Cancer Trial, Not Yet Recruiting
NCT07367178
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
- The person joining (or their legal representative, if applicable) must be able to understand the purpose of the study and must have signed a written consent form before any study procedures begin.
- Participants must be 18 years of age or older at the time of signing the consent form.
- Participants must have a general health status rated as 0 or 1 on the ECOG scale, meaning they are fully active or have only minor restrictions on physically demanding activity (confirm with trial site).
- Participants must have a life expectancy of at least 12 weeks at the time of screening.
- Participants must have locally advanced or metastatic breast cancer that cannot be surgically removed and cannot be cured, confirmed by CT scan or MRI.
- For people with triple-negative breast cancer (TNBC) only: the cancer must be confirmed as TNBC on the most recent biopsy sample, meaning it tests negative for estrogen receptor (ER), progesterone receptor (PgR), and HER2 protein, as defined by specific laboratory testing standards.
- For people with hormone receptor-positive, HER2-negative (HR+/HER2-) breast cancer only: the cancer must be confirmed as HR+/HER2- on the most recent biopsy sample, meaning it tests positive for ER and/or PgR and negative for HER2, as defined by specific laboratory testing standards.
- For people with HR+/HER2- breast cancer only: the cancer must have continued to grow or spread during or after at least one prior hormone-based treatment for advanced disease.
- For people with HR+/HER2- breast cancer only: the cancer must have continued to grow or spread during or after prior treatment with a CDK4/6 inhibitor (a specific type of targeted cancer drug), either for advanced disease or in an earlier setting — with additional timing requirements if used earlier (confirm with trial site).
- Note: For participants whose tumours show low levels of oestrogen receptor expression (between 1% and 10%), prior CDK4/6 inhibitor or hormone therapy is permitted but not required.
- Participants must have had no more than two prior standard chemotherapy-based treatment regimens for advanced disease (a type of drug called an ADC also counts as chemotherapy for this purpose).
- Note: Earlier chemotherapy given before or after surgery for early breast cancer counts as one of these prior regimens if the cancer became advanced within 12 months of finishing that treatment.
- Prior treatment with a TROP2-targeting ADC and/or a topoisomerase I inhibitor (or an ADC containing one) is only permitted if it was given in an earlier (before or after surgery) setting and the cancer did not become advanced until at least 12 months after finishing that treatment.
- Participants must have disease that can be measured or evaluated on scans, according to standard criteria called RECIST v1.1.
- Participants must have adequate bone marrow, kidney, and liver function, including sufficient blood cell counts without needing recent transfusions or growth factor support, and kidney and liver test results within acceptable ranges (specific values will be checked by the trial site).
- Note: People with a confirmed condition called Gilbert's syndrome may still be eligible provided their bilirubin level is below a certain threshold and the condition is documented in their medical history (confirm with trial site).
- Participants must be willing to provide their most recent stored tumour tissue sample at the start of the study, as well as blood and stool samples at set timepoints during the study.
- Any side effects from previous cancer treatments must have cleared or reduced to a mild level (grade 1 or lower) before joining, except for hair loss or other side effects the treating doctor considers not to be a safety concern.
- Women who could become pregnant and are sexually active with a male partner who has not been surgically sterilised must have a negative blood pregnancy test within 14 days before starting study treatment, and must agree to use a highly effective form of contraception from screening until six months after the last dose of study treatment; they must also avoid donating eggs and must not breastfeed during this period.
- Male participants who are sexually active with a female partner who could become pregnant must either be surgically sterilised or use an acceptable form of contraception from screening until three months after the last dose of study treatment, and must not donate or bank sperm during this period.
- Participants must be able to attend treatment visits and follow-up appointments.
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 are currently participating in another clinical trial (whether it involves an intervention or is observational) are not eligible until the safety visit for that other study has been completed; participation in retrospective studies or data analysis is allowed.
- People with cancer that has spread to the membranes surrounding the brain and spinal cord (leptomeningeal disease), or with active, uncontrolled, or symptomatic cancer spread to the brain or central nervous system, are not eligible; however, people with a past history of brain metastases may be eligible if they have been treated locally, are clinically stable, and have not needed anti-seizure medications or steroids for at least 14 days before the first study dose (confirm with trial site).
- People who currently have another cancer, or who have had a different cancer within the past three years, are generally not eligible — with exceptions for certain skin cancers or cervical changes that have already been treated with curative intent; other low-risk cases may be considered after discussion with the study medical team.
- People with a known allergy or hypersensitive reaction to the study drug(s) or any of their ingredients are not eligible.
- People at risk of difficulty urinating (for example, due to an enlarged prostate), those with a history of glaucoma (either type), or those previously diagnosed with myasthenia gravis are not eligible, as these are conditions where one of the study-related medications (atropine) may not be safe to use.
- People who need to continue taking any medications that are listed as prohibited in the study protocol are not eligible.
- People who have received radiotherapy within two weeks before the first study dose (or within four weeks if radiation was to the brain or central nervous system) are not eligible; participants must have recovered from radiation-related side effects and must not need steroids.
- People who have had a major surgical procedure or a serious injury within 14 days before the first study dose, or who are expected to need major surgery during the study, are not eligible.
- People with a history of unstable chest pain (unstable angina), heart attack, or heart failure within the past six months, or with a significant heart rhythm problem requiring medication, or a history of prolonged QT interval (a specific heart electrical abnormality), are not eligible.
- People with a significant active lung problem at the time of screening — such as an active lung infection or an uncontrolled flare-up of a chronic lung condition — are not eligible; note that people with stable chronic lung conditions may be enrolled but will be monitored carefully (confirm with trial site).
- People with a known history of significant bleeding, blood clots, bowel blockage, or a hole in the bowel (gastrointestinal perforation) within the past six months are not eligible.
- People with inflammatory bowel disease (such as Crohn's disease or ulcerative colitis) or any pre-existing condition that causes ongoing diarrhoea at grade 1 or above are not eligible.
- People with any other serious medical condition or abnormal laboratory results that the study investigator believes would make participation unsafe are not eligible.
- People with a current active hepatitis B or hepatitis C virus infection are not eligible; people with a past or resolved hepatitis B infection, or those who test positive for hepatitis C antibodies but have no detectable hepatitis C virus in their blood, may be eligible (confirm with trial site).
- People with a known primary immune deficiency or active HIV infection are generally not eligible; however, people living with HIV who are on stable antiretroviral therapy (ART) with well-controlled HIV may be eligible if they meet specific blood count, virus level, and medication requirements — and provided their ART regimen does not include medications that could interfere with the study drug (confirm with trial site).
- People with another active, uncontrolled infection at the time of enrolment are not eligible.
- People who have received a live or weakened (attenuated) vaccine within 30 days before the first study dose are not eligible.
- Women who are pregnant or breastfeeding, or anyone not willing to use highly effective contraception as defined in the study protocol, are not eligible.
- People who have received any approved or experimental cancer treatment within 14 days before starting study treatment are not eligible.
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.
GP referral letter
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Trial details
Status
Not Yet Recruiting
Phase
Phase 2
Sponsor
MedSIR
Registry
ClinicalTrials.gov
Start date
1 July 2026
Est. completion
1 June 2027
Primary endpoints
To assess the incidence and severity of diarrhea during the first two treatment cycles
Can't join this trial?
Data last synced from ClinicalTrials.gov: 1 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.