Phase 2 Breast Cancer Trial, Not Yet Recruiting NCT06975462 Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Condition: Breast Cancer
Back to Breast Cancer

Phase 2 Breast Cancer Trial, Not Yet Recruiting

NCT06975462
Not Yet Recruiting Phase 2

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 cancer has been confirmed by a pathologist as HER2-positive or HER2-low advanced breast cancer (based on specific test results).
  • The person is older than 18 years.
  • Brain metastases (cancer that has spread to the brain) have been newly diagnosed and confirmed by a special type of brain scan (enhanced MRI), with fewer than 6 areas of spread.
  • The person has received no more than four previous treatment regimens for advanced disease.
  • Life expectancy is more than 3 months.
  • There are no known or suspected signs of cancer spreading to the lining of the brain or spinal cord (leptomeningeal metastases).
  • At least 2 weeks have passed since the last treatment, and any side effects from previous treatment have mostly resolved.
  • Certain medications (mannitol, bevacizumab, or hormone therapy) are permitted before joining, provided the dose has been stable for at least one week without needing to be increased.
  • Recent blood test results must meet specific requirements for blood cell counts, liver function, kidney function, heart function, and clotting (confirm with trial site), and must have been taken within 28 days before registration.
  • The person has read and signed a consent form before entering the 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.

  • Cancer has spread to the lining of the brain or spinal cord, or there is bleeding within the brain metastases.
  • The person has previously been treated with a drug called T-DXd (trastuzumab deruxtecan).
  • The person has epilepsy that is not well controlled.
  • The person has severe or uncontrolled serious health conditions, such as serious heart disease, end-stage kidney disease, severe liver disease, a history of immune system problems (including HIV), active hepatitis B or C, other immune deficiency conditions, a history of organ transplant, or an active infection.
  • The person has a known allergy to any of the treatments used in this trial.
  • The person is pregnant or breastfeeding, or is a woman of childbearing age who is not willing to use contraception.
  • The person is unable to undergo an enhanced MRI scan.
  • The trial sponsor has identified specific reasons that make the person unsuitable for inclusion (confirm with trial site).

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.
Last synced 30 July 2026

Contact this trial

Phone: 13971139665

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
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Registry
ClinicalTrials.gov
Start date
1 June 2025
Est. completion
1 June 2027

Primary endpoints

The objective response rate of intracranial(IC-ORR)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

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.

View original record on ClinicalTrials.gov