Breast Cancer Trial, Recruiting NCT07095023 Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Condition: Breast Cancer
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Breast Cancer Trial, Recruiting

NCT07095023
Recruiting Not Applicable

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:

  • People aged between 18 and 75 years old
  • People who have been diagnosed with HER2-positive invasive breast cancer, confirmed through a tissue sample (biopsy), at specific stages of disease (not too early and not spread to distant parts of the body — confirm exact staging with the trial site)
  • People whose cancer tests show HER2 overexpression, meaning the HER2 protein is strongly present or the HER2 gene is amplified, as measured by specific laboratory tests
  • People whose heart is pumping blood effectively, with a heart function measurement (called LVEF) of 50% or higher
  • People who are generally well enough to carry out daily activities, rated 0 or 1 on a standard health performance scale (meaning fully active or restricted in strenuous activity only)
  • People whose blood test results show that the bone marrow, liver, and kidneys are functioning within acceptable ranges, without having needed blood transfusions or blood-boosting medications in the two weeks before starting the trial

Who may not be able to join:

  • People with a previous history of invasive breast cancer
  • People with cancer affecting both breasts, or a type called inflammatory breast cancer
  • People who have already had surgery to remove or sample the main breast tumour or underarm lymph nodes
  • People who have previously received any systemic treatment (such as chemotherapy or targeted therapy) for breast cancer
  • People who have had a severe allergic reaction to any component of the investigational drug in the past, or who are known to be allergic to it
  • People who have taken part in another clinical trial or received an experimental drug or device within the 4 weeks before starting this trial, or who would do so during this trial
  • People who have had major surgery within 28 days before starting the trial, or who have major surgery planned during the study
  • People who have had another type of cancer in the past 5 years, with some exceptions such as certain early-stage or skin cancers (confirm with trial site)
  • People with active tuberculosis or serious infections requiring treatment throughout the body, such as severe pneumonia or blood infections
  • People with a history of immune system conditions such as HIV, lupus, or rheumatoid arthritis, or who have had an organ transplant
  • People with certain heart or brain blood vessel conditions, including unstable chest pain, significant heart rhythm problems requiring medication, a heart attack in the past 6 months, heart failure, significant heart conduction problems, or a stroke or brain bleed in the past 6 months
  • People with poorly controlled high blood pressure despite taking medication, or a history of hypertensive crisis or brain complications from high blood pressure
  • People who are unable to swallow or absorb oral medication, including those with significant digestive conditions such as intestinal blockage, Crohn's disease, or ulcerative colitis
  • People who are pregnant, breastfeeding, have a positive pregnancy test at screening, or are unwilling to use effective contraception during the study and for 6 months after the last dose

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 22 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Qiang Liu, PhD, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Phone: 86-13922251256

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
Not Applicable
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Registry
ClinicalTrials.gov
Start date
15 August 2025
Est. completion
30 December 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Total Pathological Complete Response(tpCR)

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: 22 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