Breast Cancer Trial, Not Yet Recruiting NCT06383663 Sponsor: Sun Yat-sen University Condition: Breast Cancer
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Breast Cancer Trial, Not Yet Recruiting

NCT06383663
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

  • People with previously untreated primary breast cancer that has spread to the lymph nodes above the collarbone (supraclavicular lymph nodes), or people who developed this spread within 5 years after completing treatment, with no other spread elsewhere — meeting specific staging criteria defined in international guidelines from 2018.
  • The spread to the lymph nodes above the collarbone has been confirmed by a tissue sample (biopsy) examined in a lab.
  • People who agree to have tissue samples (biopsies) taken from both the breast cancer and the affected lymph nodes above the collarbone.
  • People with primary breast cancer who have no history of other cancers and have not previously received chemotherapy, radiation therapy, or hormone therapy.
  • People who have at least one measurable area of cancer that can be tracked using standard imaging guidelines (called RECIST criteria).
  • People who are generally well enough to carry out light activity and care for themselves — rated 0 or 1 on a standard health performance scale (ECOG score).
  • People whose blood, liver, and kidney function meet minimum levels required for the trial, including healthy enough blood cell counts, liver enzyme levels within an acceptable range, and kidney function above a set threshold (confirm with trial site for exact values).
  • People whose pre-treatment scans — including abdominal ultrasound, chest CT or MRI, bone scan, or PET/CT — show no signs of cancer having spread to distant parts of the body.
  • People who are mentally well and able to cooperate with the full course of treatment.
  • People with an expected survival of at least 36 months.
  • People who have signed an informed consent form (either themselves or through a legal representative and family member) as required by the Ethics Committee.

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 whose cancer has spread beyond a specific region of the neck (outside the neck IV and VB area) (confirm with trial site).
  • People for whom complete surgical removal of the affected tissue in one procedure is not possible.
  • People with heart, lung, blood vessel, or other conditions that would prevent them from receiving cancer treatment.
  • People whose pre-treatment scans show the cancer has already spread to distant parts of the body.
  • People who are pregnant, breastfeeding, or have a type of breast cancer called inflammatory breast cancer.
  • People who have conditions affecting the immune system, hormone (endocrine) system, or heart and circulation.
  • People who have a previous history of another type of cancer, or who currently have another cancer alongside their breast cancer.
  • People who are unwilling to follow the study plan or refuse to sign the informed consent form.

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 31 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: Weidong Wei, Professor, Sun Yat-sen University

Phone: +8613822278328

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
Not Yet Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
1 May 2024
Est. completion
31 December 2028

Primary endpoints

DFS

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: 31 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