Phase 3 Breast Cancer Trial, Recruiting NCT06341621 Sponsor: Fudan University Condition: Breast Cancer
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Phase 3 Breast Cancer Trial, Recruiting

NCT06341621
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:

  • Women between 18 and 80 years old
  • People who have had surgery for early-stage breast cancer where the cancer has spread to 1–3 nearby lymph nodes, the tumour is classified as T1 or T2 (relatively small), and lab testing has confirmed the cancer is hormone receptor-positive (ER+) and HER2-negative
  • People whose cancer tests show that at least 50% of cancer cells are ER-positive (a specific hormone receptor measurement)
  • People who are generally well enough to carry out light daily activities, with little or no limitation (confirm with trial site on how this is assessed)
  • People whose blood, liver, and kidney test results fall within acceptable ranges — including healthy levels of red blood cells, white blood cells, and platelets, as well as normal liver enzyme and kidney function levels (confirm with trial site for exact values)
  • People who have given their written agreement to take part and are willing to attend follow-up appointments

Who may not be able to join:

  • People who received chemotherapy, targeted therapy, radiation, or hormone therapy before their surgery (neoadjuvant therapy)
  • People who have cancer in both breasts
  • People with a history of another cancer, unless it was a certain type of very early skin cancer (basal cell carcinoma) or early cervical cell changes (cervical carcinoma in situ) that were fully treated
  • People whose breast cancer has spread to other parts of the body (Stage 4 or metastatic)
  • People whose tumour is classified as T3 or larger (a larger tumour size category)
  • People who are pregnant, breastfeeding, or of childbearing age and unable to use effective contraception during the trial
  • People who are currently taking part in another clinical trial at the same time
  • People with serious heart, lung, liver, or kidney problems — including reduced heart pumping function, a recent heart attack or stroke, uncontrolled high blood pressure, poorly controlled diabetes, or severe infection
  • People whom the trial doctors consider unsuitable for the study for other medical reasons

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 16 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: Zhimin Shao, MD, PhD, Fudan University

Phone: +86-021-64175590

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
2 April 2024
Est. completion
25 February 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Invasive disease free survival

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: 16 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