Phase 2 Breast Cancer Trial, Not Yet Recruiting NCT07423611 Sponsor: Fudan University Condition: Breast Cancer
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Phase 2 Breast Cancer Trial, Not Yet Recruiting

NCT07423611
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

  • The person has signed and dated a Patient Informed Consent Form before any trial-related screening takes place.
  • The person is female with a known menopausal status at the time of joining the trial.
  • The person is aged 18 to 70 years old at the time of signing the consent form.
  • The person has been diagnosed with a specific type of breast cancer (invasive adenocarcinoma) affecting one breast, confirmed through laboratory analysis of tissue, with a recorded date of diagnosis.
  • The person's breast cancer tests positive for hormone receptors (ER and/or PgR), based on the most recently tested tissue sample.
  • The person's breast cancer tests negative for a protein called HER2, confirmed through specific laboratory tests on the most recently tested tissue sample (confirm with trial site for exact testing requirements).
  • The person has had surgery to fully remove the tumour, with no cancer cells found at the edges of the removed tissue, and their cancer falls into one of these categories: the tumour is small-to-medium and has spread to nearby lymph nodes (T0–2, N1); the tumour is larger but has not spread to lymph nodes (T3–4, N0); or the tumour meets a specific size and node category (T2N0) along with additional features such as a high-grade tumour rating (Grade 3), or a Grade 2 tumour with high cell activity or high genetic risk (confirm with trial site).
  • The treating doctor has determined the person is suitable for chemotherapy given after surgery, based on clinical findings or genetic test results.
  • The person has a performance status score of 0 or 1, meaning they are fully active or have only minor restrictions on physical activity.
  • A specific blood test (ctDNA-MRD) taken within 4 weeks after surgery shows a negative result.
  • The person has adequate blood, kidney, and liver function as confirmed by laboratory tests.

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.

  • The person has already received systemic treatment for breast cancer before or after surgery, including chemotherapy, targeted therapy, or hormone therapy.
  • The person has breast cancer affecting both breasts.
  • The person has breast cancer that has spread to distant parts of the body beyond the nearby lymph nodes (stage IV), or there is evidence that the cancer has come back after surgery.
  • The person has had another active cancer within the past 2 years.
  • The person is pregnant, breastfeeding, or plans to become pregnant or breastfeed during the trial.
  • The person has a digestive system condition or disease that could significantly affect how oral trial medications are absorbed by the body.
  • The person has not sufficiently recovered from side effects of previous cancer treatments to an acceptable level at the time of joining the trial (confirm with trial site for specific recovery standards).
  • The person has taken part in another clinical trial involving an experimental drug within 30 days before joining this trial, or within a specific timeframe related to that drug's duration in the body (whichever is longer), or has been involved in other medical research considered incompatible with this trial.

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 24 July 2026

Contact this trial

Phone: 86-21-64175590-88808

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
1 October 2026
Est. completion
1 October 2030

Where this trial is recruiting

🇨🇳 China

Primary endpoints

ctDNA negativity rate

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: 24 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