Printed from Voxsanity (voxsanity.com.au) — NCT07178938 — 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
NCT07178938
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 patient, or their legal representative, must be able to understand the study's purpose and must have signed a consent form before any study procedures begin.
- People aged 18 or older at the time of signing the consent form.
- People with breast cancer that has been confirmed by imaging to be locally advanced and unable to be removed by surgery, or that has spread to other parts of the body.
- People whose breast cancer has been confirmed by tissue testing to be HER2-positive, based on the most recent biopsy tested according to current guidelines.
- People who have brain metastases (cancer that has spread to the brain) that are either newly diagnosed and untreated, or that have come back or grown after previous local treatment — any number of brain lesions is acceptable as long as all other criteria are met.
- People who have at least one measurable brain lesion of 10mm or larger, as seen on a specific type of brain MRI scan.
- People who may or may not have a specific type of cancer spread to the lining of the brain and spinal cord (called type I leptomeningeal disease), as defined by established guidelines.
- People whose steroid medication dose has been stable or decreasing, or who are not taking steroids at all, for at least 7 days before joining the trial.
- People with a general health and activity level rated at 2 or below on a standard scale used by doctors to measure how cancer affects daily functioning (ECOG performance status).
- People with a life expectancy of at least 6 weeks at the time of screening.
- People whose side effects from previous cancer treatments have mostly resolved to a mild level, with exceptions for hair loss or other side effects the doctor considers low-risk.
- People whose blood, liver, and kidney test results fall within acceptable ranges in the 7 days before the first study treatment dose (confirm specific values with trial site).
- Women who could become pregnant and are sexually active with a male partner who has not had a sterilisation procedure must have a negative pregnancy blood test within 14 days before starting treatment, and must agree to use a highly effective form of contraception for the entire time they are in the study.
- Male participants who are sexually active with a female partner who could become pregnant must either have had a sterilisation procedure or use an acceptable form of contraception for the entire time they are in the study.
- People who are able to attend treatment sessions and follow-up appointments as required.
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 taking part in another clinical trial or interventional study (participation in retrospective studies or data analysis is allowed).
- People who have received any approved or experimental cancer treatment within 14 days before the start of the study drug.
- People with a known history of another invasive cancer within the past 5 years, with some exceptions such as certain treated skin cancers or cervical cancer in situ — other low-risk cancers may be considered after discussion with the study's medical team.
- People with a known allergy or sensitivity reaction to any of the study's investigational medicines or their components.
- People who have had a major surgical procedure or significant injury within 14 days before the first study dose, or who are expected to need major surgery during the study.
- People who are pregnant or breastfeeding, or people not willing to use effective contraception as defined by the study.
- People who have received a live or weakened (attenuated) vaccine within 30 days before the first study dose.
- People with an active or uncontrolled hepatitis B or hepatitis C infection (people with past or resolved hepatitis B or C infections may still be eligible under certain test result conditions — confirm with trial site).
- People with a known HIV infection that is not well managed.
- People with any other active, uncontrolled infection at the time of joining the trial.
- People who are receiving steroid tablets or injections affecting the whole body, or any other medication that suppresses the immune system, within 7 days before the first study dose.
- People with a history of uncontrolled seizures, serious nervous system disorders, or significant unstable psychiatric conditions that the doctor believes could affect their ability to safely take part in the study.
- People with known substance abuse issues, or any other serious uncontrolled medical condition that the doctor believes would make participation unsafe.
- People with any serious medical condition or abnormal test results that the doctor believes would prevent safe participation in and completion of the study.
- People who are unable or unwilling to follow the study's requirements, in the opinion of the doctor overseeing the trial.
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
Phone: +34 932 214 135
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
Not Yet Recruiting
Phase
Phase 2
Sponsor
MedSIR
Registry
ClinicalTrials.gov
Start date
30 April 2026
Est. completion
30 November 2026
Primary endpoints
Proportion of patients showing target expression
Can't join this trial?
Data last synced from ClinicalTrials.gov: 17 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.