Phase 3 Breast Cancer Trial, Recruiting NCT07528716 Sponsor: Fudan University Condition: Breast Cancer
Back to Breast Cancer

Phase 3 Breast Cancer Trial, Recruiting

NCT07528716
Recruiting Phase 3

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

  • Women between the ages of 18 and 75.
  • People whose general health and ability to carry out daily activities meets a specific functional standard (ECOG score of 0 or 1 — confirm with trial site if unsure what this means).
  • People with a confirmed diagnosis of invasive breast cancer in one breast only, at a stage that is at least stage II or III (but not spread to distant parts of the body).
  • People whose breast cancer has been confirmed as HER2-positive through specific laboratory tests.
  • People who have at least one tumour that can be measured using standard imaging criteria.
  • People whose blood counts are within acceptable ranges without recent blood transfusions or growth factor support — including haemoglobin, white blood cell count, and platelet levels meeting specific thresholds.
  • People whose liver and kidney function blood test results are within acceptable ranges for this trial.
  • People whose heart electrical activity (ECG) and heart pumping function (measured by echocardiogram) meet specific standards set by the trial.
  • Women who are able to become pregnant must agree to use at least one medically accepted form of contraception throughout the treatment period and for at least 3 months after the last dose.
  • People who are willing to take part voluntarily, sign a consent form, follow the study requirements, and attend follow-up appointments.

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 with breast cancer affecting both breasts, inflammatory breast cancer, or breast cancer that has already spread to distant parts of the body (stage IV).
  • People who have previously received any systemic treatment for any reason, including chemotherapy, targeted therapy, hormone therapy, biological therapy, radiation, or immunotherapy.
  • People with a known or suspected lung condition called interstitial pneumonitis, or moderate to severe lung disease that significantly affects breathing, such as severe asthma or severe chronic obstructive pulmonary disease (COPD).
  • People with serious heart or blood vessel conditions, including heart failure of a certain severity, a heart attack or stroke within the 3 months before starting the trial, or ongoing irregular heart rhythms of a certain severity.
  • People with a serious active infection requiring intravenous antibiotics, antifungal, or antiviral treatment, or an unexplained high fever (above 38.5°C) at the time of screening or before the first dose.
  • People who have had significant bleeding episodes in the month before signing the consent form, or who have a known tendency to bleed, such as gastrointestinal bleeding or certain stool test results indicating blood.
  • People with a known allergy or intolerance to any of the study drugs or their ingredients.
  • People who have had another cancer in the past 5 years, except for certain treated skin cancers or cervical carcinoma in situ that has been fully cured.
  • People who are pregnant or breastfeeding, or women who are able to become pregnant but are unwilling to use appropriate contraception during the trial.
  • People who have taken part in another clinical trial within 30 days before the first dose of the study drug.
  • People who, in the treating doctor's judgement, are not suitable for the study for any other reason.

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 7 July 2026

Contact this trial

Phone: 18017312288

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
Registry
ClinicalTrials.gov
Start date
1 May 2026
Est. completion
1 December 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

pathologic Complete Response (pCR)

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: 7 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