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Phase 2 Breast Cancer Trial, Recruiting
NCT06016387
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
Phase 1
- People diagnosed with HER2-positive, HER2-mutated, and/or HER2-amplified breast cancer that has spread to other parts of the body (metastatic), as confirmed by established medical guidelines or through blood and/or spinal fluid testing done before joining the trial.
- People with evidence of cancer spreading to the lining of the brain and/or spine (called leptomeningeal disease, or LMD), shown through spinal fluid testing and/or MRI scan — this diagnosis can have been made at any point before joining.
- People aged 18 or older at the time of giving consent to join.
- People with a general health status rated at ECOG 2 or below, meaning they are able to carry out some daily activities (confirm with trial site for exact definition).
- People who have waited more than 14 days, or five half-lives (whichever is longer), since their last dose of any experimental treatment.
- People whose side effects from previous cancer treatments have largely settled — most side effects must have reduced to a mild level (Grade 1 or lower), except for hair loss, and nerve-related side effects must have reduced to Grade 2 or lower.
Phase 2 (additional criteria)
- People whose heart pumping function (left ventricular ejection fraction) falls within the normal range, as measured by a heart scan (ECHO or MUGA) done within 2 weeks before starting treatment in the study.
- People with adequate blood, liver, and kidney function within 2 weeks before joining Phase 2, meeting all of the following levels (confirm with trial site for exact values):
- Red blood cell levels (haemoglobin) of at least 9 g/dL
- White blood cell levels (ANC) of at least 1 x10⁹/L
- Platelet levels of at least 100 x10⁹/L
- Bilirubin (a liver marker) no more than 1.5 times the upper limit of normal
- Liver enzymes (AST and ALT) no more than 2.5 times the upper limit of normal
- Blood clotting measures (INR and aPTT) no more than 1.5 times the upper limit of normal
- Kidney function (creatinine clearance) of at least 50 mL/min
- People whose last dose of any previous treatment was completed at least 14 days before joining — previous chemotherapy, immunotherapy, hormone therapy, targeted therapy, and experimental treatments are all permitted, including prior use of trastuzumab or similar antibody-based treatments, and prior use of capecitabine alone or in combination with other HER2-targeted therapies.
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.
Phase 1
- People who have previously had whole-brain radiation therapy for brain metastases, or who had stereotactic radiosurgery (a focused form of radiation) to brain tumours less than 7 days before giving consent.
- People who have previously received any treatment specifically aimed at leptomeningeal disease, including radiation or systemic (whole-body) therapy directed at LMD.
- People who are unable to have regular MRI scans to monitor the cancer in the brain or spine.
- People who are unable to swallow pills, or who have significant digestive conditions such as inflammatory bowel disease with uncontrolled diarrhoea, which could prevent oral medications from being properly absorbed.
- People who have been diagnosed with hereditary fructose intolerance.
- People who have been diagnosed with Gilbert's disease (a liver condition).
- People with a history of another cancer (other than certain skin cancers or a non-invasive cervical condition) that has shown signs of being active within the last 5 years.
- People who have previously received the drug tucatinib at any point before joining the trial.
- People who have had a serious allergic reaction to tucatinib, trastuzumab, or capecitabine, or any of their ingredients.
Phase 2
- People who are currently pregnant or breastfeeding.
- People who have recently taken certain medications that strongly affect how the body processes drugs (specifically strong CYP2C8 inhibitors within 5 half-lives, or strong CYP3A4 or CYP2C8 inducers within 5 days before the first dose of study treatment) — confirm with the trial site which specific medications apply.
- People who have had a heart attack or severe chest pain (unstable angina) within 6 months before starting study treatment.
- People who would need a blood transfusion specifically in order to meet the blood count requirements for joining 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: 437-247-2617
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 2
Registry
ClinicalTrials.gov
Start date
25 November 2023
Est. completion
31 December 2026
Where this trial is recruiting
🇨🇦 Canada
Primary endpoints
Survival status from the start of XRT
Can't join this trial?
Data last synced from ClinicalTrials.gov: 6 August 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.