Phase 2 Breast Cancer Trial, Not Yet Recruiting NCT06787339 Sponsor: Fudan University Condition: Breast Cancer
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Phase 2 Breast Cancer Trial, Not Yet Recruiting

NCT06787339
Not Yet Recruiting Phase 2

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 aged 18 or older, of any gender.
  • People who have been confirmed through laboratory testing to have Stage I breast cancer, where the invasive tumour measures no more than 2 cm and cancer has not spread to the lymph nodes.
  • People who have been confirmed through tissue testing to have triple-negative breast cancer (TNBC) — meaning the tumour does not have HER2, oestrogen receptor (ER), or progesterone receptor (PR) — diagnosed after early breast cancer surgery.
  • People who have already completed standard and adequate surgery for their breast cancer.
  • People whose blood, liver, and kidney test results meet specific minimum levels of health as assessed by the trial team (confirm with trial site for exact values).
  • People who had no signs of cancer spread to other parts of the body before surgery, confirmed by clinical or imaging assessment.
  • People with an ECOG performance score of 0 or 1, meaning they are fully active or have only minor restrictions on physically demanding activity (confirm with trial site).
  • People who meet at least one of the following low-risk categories defined by this study: a) their tumour is classed as the "IM subtype," meaning it has a high level of immune cells called stromal tumour-infiltrating lymphocytes or high CD8 levels; b) their tumour is classed as the "LAR subtype" and their Ki-67 score (a measure of how fast cells are growing) is below 20%; or c) they are aged 70 or older.
  • People who are willing to voluntarily join the study, 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 who have already received treatment before surgery, such as chemotherapy, targeted therapy, radiation therapy, or hormone therapy (known as neoadjuvant therapy).
  • People with a history of another cancer, except for certain treated skin cancers (basal cell carcinoma) or early-stage cervical cancer that has been adequately treated.
  • People with Stage 4 (metastatic) breast cancer, meaning cancer that has spread to other parts of the body.
  • People who are pregnant or breastfeeding, or people of childbearing potential who are unable to use effective contraception.
  • People who are currently taking part in another clinical trial at the same time.
  • People with serious heart, lung, liver, or kidney problems, including a heart pumping function (LVEF) below 50%, or serious heart or brain blood vessel conditions in the past 6 months (such as unstable chest pain, heart failure, a heart attack, or a stroke); people with poorly controlled diabetes or severe high blood pressure; people with a serious or uncontrolled infection.
  • People with a history of substance abuse who are unable to stop, or people with a history of a mental health disorder.
  • People whom the trial researchers consider unsuitable for the study for any reason.
  • People who have cancer in both breasts (bilateral breast cancer).

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 29 July 2026

Contact this trial

Phone: 02164175590

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
Phase 2
Registry
ClinicalTrials.gov
Start date
15 January 2025
Est. completion
31 December 2028

Where this trial is recruiting

🇨🇳 China

Primary endpoints

RFS

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: 29 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