Breast Cancer Trial, Not Yet Recruiting NCT06537674 Sponsor: Jiangsu Famous Medical Technology Co., Ltd. Condition: Breast Cancer
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Breast Cancer Trial, Not Yet Recruiting

NCT06537674
Not Yet Recruiting Not Applicable

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 aged 18 to 75 years who are being treated for breast cancer for the first time.
  • The cancer has been confirmed through lab testing to be HER2-positive (a specific protein that affects how cancer cells grow).
  • The breast cancer has been confirmed through tissue biopsy and imaging scans as either early-stage or locally advanced (meaning it has not spread to distant parts of the body).
  • The patient has a good general health and activity level, rated 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activity).
  • The patient is planned to have surgery to remove the breast cancer, which may include breast-conserving surgery or full breast removal, along with a procedure to check or remove nearby lymph nodes.
  • Blood tests, organ function tests, heart scans, and an ECG (heart tracing) show that the heart, liver, kidneys, and blood counts are all within acceptable ranges (confirm with trial site for specific values).
  • Women who are able to become pregnant must agree to use effective contraception during treatment and for at least 7 months after the last dose.
  • The patient is willing to take part in the study and has signed a consent form.

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 a known allergy to any of the ingredients used in the trial treatments.
  • People who have previously received cancer treatment or radiotherapy for any cancer, except for certain skin or cervical conditions that have been fully cured.
  • People who have had major surgery unrelated to breast cancer within the past 4 weeks, or who have not fully recovered from such surgery.
  • People whose breast cancer has spread to other parts of the body (stage IV or metastatic).
  • People who have difficulty swallowing, a blocked bowel, or any other condition that may affect the ability to take or absorb the trial medication.
  • People with serious heart disease or heart-related symptoms that cannot be treated.
  • People with a mental illness or substance misuse issue that would make it difficult to cooperate with the study.
  • Women who are pregnant or currently breastfeeding.
  • People with severe liver, kidney, or blood disorders.
  • People considered unsuitable by the research team, including those with a history of drug misuse, use of blood products, anticoagulant medicines, or immunological medicines within the past year, or those unlikely to follow the study requirements.

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 23 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.

GP referral letter

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

Trial details

Status
Not Yet Recruiting
Phase
Not Applicable
Sponsor
Jiangsu Famous Medical Technology Co., Ltd.
Registry
ClinicalTrials.gov
Start date
15 August 2024
Est. completion
30 December 2025

This date has passed while the registry still lists the trial as open to participants. Sponsors often update a trial's status without revising its projected end date, so it may well still be recruiting — but the record is out of date in at least one respect. Check with the study contact before relying on either.

Primary endpoints

EORTC QLQ-C30 scale score

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: 23 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