Printed from Voxsanity (voxsanity.com.au) — NCT07454668 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 1 Breast Cancer Trial, Not Yet Recruiting
NCT07454668
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 who have been diagnosed with HER-2-positive breast cancer (confirmed by a laboratory test on a tissue sample) that has spread to the brain for the first time.
- People who have a level of physical functioning rated as 0, 1, or 2 on a standard medical scale (ECOG), meaning they are fully active to somewhat limited in strenuous activity but able to care for themselves.
- People who have between 1 and 10 brain tumours, where each tumour measures 3 cm or less at its widest point, and where the treating radiation specialist considers them suitable for the combination treatment used in this trial.
- People aged 18 years or older.
- People who have signed a written consent form before any trial-related procedures begin (a legal representative may sign on their behalf if needed).
- People with a life expectancy of at least 12 weeks.
- People who have received any number of prior cancer drug treatments, except for the drug T-DXd (trastuzumab deruxtecan).
- People whose blood counts meet the required levels: haemoglobin at least 9 g/dL, white blood cell count at least 3.0 × 10⁹/L, neutrophil count at least 1.5 × 10⁹/L, and platelet count at least 100 × 10⁹/L.
- People whose liver function blood test (bilirubin) is within an acceptable range (no more than 1.5 times the upper limit of normal).
- People whose liver enzyme levels (AST and/or ALT) are within an acceptable range (no more than 2 times the upper limit of normal, or up to 5 times if liver spread is clearly the cause).
- People whose kidney function is within an acceptable range, based on either a blood test or a calculated measure of kidney filtering ability (confirm with trial site).
- People who are able to follow the study procedures and attend required monitoring visits.
- People who can become pregnant must have a negative pregnancy test within 7 days before starting treatment.
- People whose heart pumping function (left ventricular ejection fraction) is at least 50%, confirmed by a heart scan within 28 days before joining the trial.
- People of reproductive potential (male or female) who are willing to use two highly effective forms of contraception throughout the trial and for 7 months after the last dose of T-DXd.
- Accepted contraception methods include: male condom plus spermicide, cap plus spermicide, diaphragm plus spermicide, copper IUD (Copper T), progesterone IUD (Progesterone T), a hormone-releasing IUD (such as Mirena®), implants, hormone injection, combined contraceptive pill, mini-pill, or contraceptive patch.
- People who are considered postmenopausal (and therefore do not require contraception) based on any of the following: no periods for 1 or more years after stopping hormone treatments; hormone levels confirming menopause in people under 50; no periods for more than 1 year following radiation to the ovaries; no periods for more than 1 year following chemotherapy-induced menopause; or surgical removal of both ovaries or the uterus.
- People of any sex, race, or ethnic background are eligible for this trial.
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 whose cancer has spread to the lining around the brain or spinal cord (leptomeningeal metastases), confirmed by MRI or spinal fluid testing.
- People with bleeding within or around a brain tumour that is considered clinically significant by the treating doctor.
- People with brain tumours located within 5 mm of the optic chiasm or optic nerve (the structures that carry vision signals).
- People with significant or recent gut problems where diarrhoea is a major symptom, such as Crohn's disease, malabsorption, or diarrhoea rated above grade 2 on a standard medical scale at the time of screening.
- People with a history of significant or uncontrolled heart disease, including heart failure, chest pain (angina), heart attack, irregular heart rhythm, or heart function rated as class 3 or 4 on the New York Heart Association scale.
- People who are unable to have a brain MRI scan.
- People with HIV infection or chronic Hepatitis B or C, as determined by testing conducted according to institutional practice.
- People whose side effects from previous treatments have not settled back to a mild level (grade 1 or better on a standard medical scale) by the time of joining the trial.
- People with other serious or uncontrolled medical conditions (such as active infection, uncontrolled diabetes, or a second active cancer) that could create unacceptable safety risks or make it difficult to follow the trial procedures.
- People who are currently taking part in another experimental cancer treatment study, or who have done so within 4 weeks before starting this trial (an exception applies for people continuing on GnRH analogue therapy — confirm with trial site).
- People with a heart rhythm measurement (QTc interval) of 470 milliseconds or more, calculated from three ECG readings (confirm with trial site).
- People whose heart pumping function (LVEF) is below 50%.
- People for whom the treating team considers T-DXd to be unsuitable.
- People for whom the treating team considers stereotactic radiosurgery (SRS — a focused form of radiation to the brain) to be unsuitable.
- People with a current or past history of interstitial lung disease or lung inflammation (ILD/pneumonitis), or where this condition cannot be ruled out by imaging at screening.
- People who have had a serious allergic reaction to T-DXd in the past.
- People with a history of, or confirmed, corneal ulceration (ulcers on the surface of the eye).
- People who are pregnant or currently breastfeeding; breastfeeding must also not occur for 7 months after stopping the study drug.
- People who would need to use anthracycline chemotherapy drugs while on this trial, as these are not permitted during participation.
- People who have previously received radiation treatment to the brain.
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: Manmeet Ahluwalia, Miami Cancer Institute
Phone: 786-596-2000
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 1
Sponsor
Baptist Health South Florida
Registry
ClinicalTrials.gov
Start date
1 June 2026
Est. completion
1 July 2028
Where this trial is recruiting
🇺🇸 United States
Primary endpoints
Incidence of dose-limiting toxicities (DLTs); Determination of the maximum tolerated dose (MTD) of T-DXd in combination with SRS
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.