Phase 3 Breast Cancer Trial, Recruiting NCT07673029 Sponsor: GeneQuantum Healthcare (Suzhou) Co., Ltd. Condition: Breast Cancer
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Phase 3 Breast Cancer Trial, Recruiting

NCT07673029
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:

  • Adults aged 18 or older at the time of signing the consent form
  • People who have been diagnosed with HER2-positive breast cancer that cannot be surgically removed or has spread to other parts of the body, and who have previously been treated with the medicines trastuzumab and taxane
  • People whose general health and ability to carry out daily activities is rated as 0 or 1 on a standard medical scale (meaning fully active or restricted only in physically strenuous activity)
  • People who have at least one tumour that can be measured using standard imaging methods
  • People whose expected survival is at least 12 weeks
  • People who are willing to give written consent to take part in the study

Who may not be able to join:

  • People who have previously received a specific type of cancer treatment called an anti-HER2 antibody-drug conjugate (ADC) (confirm with trial site)
  • People with a history of certain lung conditions — specifically interstitial lung disease, non-infectious pneumonitis, or radiation-related lung inflammation — that required treatment with steroids
  • People with a known serious allergic reaction to the study drug's active or inactive ingredients, or to similar antibody-based medicines
  • People who have had more than one type of cancer in the past 3 years, with some exceptions such as certain skin cancers, fully treated non-spreading tumours, or cancer in the opposite breast
  • People with ongoing uncontrolled infections, certain autoimmune conditions requiring treatment, uncontrolled diabetes, uncontrolled high blood pressure, or other ongoing health conditions that may make it difficult to follow the study procedures
  • People who are still experiencing side effects from previous cancer treatments that have not returned to a mild level or to their pre-treatment state (hair loss is an exception to this rule)

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
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.

Contact this trial

Principal Investigator: Zefei Jiang, M.D., The Fifth Medical Center of the Chinese People's Liberation Army General Hospital

Phone: +86 13801896162

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 3
Sponsor
GeneQuantum Healthcare (Suzhou) Co., Ltd.
Registry
ClinicalTrials.gov
Start date
10 January 2025
Est. completion
9 January 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) assessment per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

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