Phase 3 Breast Cancer Trial, Recruiting NCT05904964 Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Condition: Breast Cancer
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Phase 3 Breast Cancer Trial, Recruiting

NCT05904964
Recruiting Phase 3

Who may 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 might be able to join this trial:

  • You are a woman between 18 and 70 years old (inclusive) with breast cancer that has spread to other parts of the body, confirmed by lab tests or scans, and cannot be fully treated with surgery or radiation
  • Your breast cancer has been tested and shown to be hormone receptor positive (ER and/or PR positive) and has a low level of a protein called HER2
  • You have already received hormone-based treatment for your breast cancer
  • You have at least one tumor that can be measured on scans, or you have bone metastases of a specific type (osteolytic)
  • Any cancer that has spread to the brain is either stable or not causing symptoms
  • You are reasonably active and able to care for yourself (as measured by a standard health scale), and doctors expect you to live at least 3 more months
  • Any side effects from previous treatments have mostly cleared up before joining the trial (minor hair loss may be an exception)
  • Your blood counts are at an acceptable level, including white blood cells, infection-fighting cells (neutrophils), and platelets
  • Your liver, kidneys, and heart are functioning within acceptable ranges based on recent blood tests and heart scans
  • You fully understand what the trial involves and are willing to sign a consent form

Who may not be able to join:

  • You have received chemotherapy, radiation, immunotherapy, or hormone therapy for breast cancer within the 2 weeks before joining
  • You had a major surgical procedure within the 2 weeks before joining
  • You have had a serious heart condition in the past 12 months, such as unstable chest pain, a heart attack, a brain bleed, or a stroke
  • You have an active autoimmune disease (where your immune system attacks your own body) that has required ongoing medication in the past 2 years
  • You have a known neurological or mental health condition, such as epilepsy or dementia
  • You have another serious illness that the trial doctors believe could put you at risk or prevent you from completing the study
  • You have a known allergy to the study drug (Disitamab Vedotin) or similar medications
  • The trial doctors feel you may not be able to follow the study requirements, or there are other reasons they feel the trial is not right for you

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 2 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Registry
ClinicalTrials.gov
Start date
1 July 2023
Est. completion
1 March 2028

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Progression free survival (PFS)

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: 2 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