Printed from Voxsanity (voxsanity.com.au) — NCT07152782 — 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
NCT07152782
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
- Women between 18 and 70 years old.
- People with a performance status score of 0 or 1 on the ECOG scale, which means they are fully active or have only minor limits on physical activity (confirm with trial site).
- People whose doctors expect them to live for more than 12 weeks.
- People whose breast cancer has been confirmed by a tissue sample to be invasive and HER2-positive (a specific type of breast cancer identified by laboratory testing).
- People with breast cancer that has come back after earlier treatment or has spread to other parts of the body; those with cancer that has returned locally must have been assessed by a doctor as unable to have complete surgical removal.
- People who have at least one area of cancer that has not previously been treated with radiation.
- People whose brain scan (MRI or CT) shows cancer that has spread to the brain, in one of these situations: untreated brain metastases found on imaging; or previously treated brain metastases that are either stable on imaging for 4 weeks or more, or show new areas of spread on a brain scan.
- People who have received no more than 2 prior lines of treatment for their spread of cancer, and who have not previously received the drugs T-DXd or neratinib (nalatinib).
- People whose blood test results meet certain minimum levels for red blood cells, white blood cells, and platelets, without having had a blood transfusion in the past 14 days (confirm specific values with trial site).
- People whose liver and kidney function test results fall within acceptable ranges as defined by the trial (confirm specific values with trial site).
- People who, if using mannitol or hormone therapy before joining, have been on a stable dose for at least one week without needing an increase.
- Women who are able to have children and agree to use effective contraception until 3 months after the last dose of study medication.
- People who have voluntarily agreed to take part, have signed a consent form, and are willing to follow the study requirements including attending follow-up visits.
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 received more than 2 prior lines of treatment for their spread of cancer, or who have previously been treated with T-DXd or neratinib (nalatinib).
- People whose cancer has spread to the lining around the brain or spinal cord (meningeal metastasis).
- People whose brain metastases require urgent treatment, or who need more than 3mg per day of dexamethasone (a steroid) or an equivalent drug to manage brain swelling.
- People with a significant or uncontrolled heart condition, including heart failure, angina, a heart attack in the past 6 months, or serious irregular heart rhythms.
- People still experiencing side effects of grade 2 or higher from previous cancer treatments (not including hair loss).
- People who are pregnant.
- People who have had another type of cancer in the past 5 years, except for certain cured skin or cervical conditions as determined by the trial site.
- People who have difficulty swallowing, ongoing diarrhea, or a blocked bowel, or other conditions that would affect the ability to take or absorb oral medication.
- People with large uncontrolled fluid build-up in body cavities (such as significant fluid around the lungs or in the abdomen) that cannot be managed by drainage or other means.
- People who have taken part in another clinical trial of an anti-cancer drug within the 4 weeks before the first dose of this study drug.
- People with wounds or bone fractures that have not healed over a long period of time.
- People with a known active hepatitis B (HBV) or hepatitis C (HCV) infection.
- People with a known primary immune deficiency condition or who are known to be HIV positive.
- People with an active infection currently requiring intravenous antibiotics, antiviral drugs, or antifungal drugs.
- People with a history of lung inflammation (ILD/pneumonitis) that required steroid treatment, who currently have lung inflammation, or where lung inflammation cannot be ruled out on imaging during the screening period.
- People with serious lung conditions, including but not limited to pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, or significant fluid around the lungs within 3 months before joining the trial.
- People with any autoimmune, connective tissue, or inflammatory disease (such as rheumatoid arthritis, Sjögren's syndrome, or sarcoidosis) where there is a record or suspicion of lung involvement.
- People who have previously had a complete surgical removal of one entire lung.
- People with known allergies to any component of the study medication, or who have a history of allergic reactions to other monoclonal antibody treatments.
- People whose substance use or medical conditions are considered by the study doctors likely to interfere with their participation or with the evaluation of results.
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: 08664175590 Ext. 88807
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
Registry
ClinicalTrials.gov
Start date
1 November 2025
Est. completion
1 November 2027
Primary endpoints
Progression Free Survival(PFS)
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.