Phase 4 Breast Cancer Trial, Not Yet Recruiting NCT05871437 Sponsor: Fudan University Condition: Breast Cancer
Back to Breast Cancer

Phase 4 Breast Cancer Trial, Not Yet Recruiting

NCT05871437
Not Yet Recruiting Phase 4

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 between 18 and 75 years old, of any gender.
  • People who have been diagnosed with breast cancer confirmed by pathology (tissue analysis) after surgery.
  • People whose imaging scans and pathology tests show no signs of the cancer coming back or spreading.
  • People with raised tumour markers who have already been assessed by the relevant medical department to rule out cancer recurrence, spread, or a new primary tumour, where needed.
  • People who have at least one of the following tumour markers — CEA, CA125, or CA153 — above the normal upper limit.
  • People whose liver and kidney function test results fall within the required ranges (confirm with trial site for exact values).
  • People whose blood test results, including haemoglobin, platelet count, and neutrophil count, meet the required minimum levels (confirm with trial site for exact values).
  • People with an ECOG performance score of 0 or 1, meaning they are fully active or have only minor restrictions on physical activity.
  • People who have voluntarily agreed to take part and have signed an informed 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 who have been diagnosed with any other cancer in the five years before enrolling, unless it was a low-risk cancer such as fully treated basal cell or squamous cell skin cancer, or cervical cancer in situ.
  • People whose imaging or pathology tests have confirmed the breast cancer has returned or spread.
  • People who had a serious infection in the four weeks before enrolling, or who had signs of infection or needed antibiotic treatment (other than preventive antibiotics) in the two weeks before enrolling.
  • People who have a severe ongoing acute or chronic illness.
  • People with severe diabetes where blood sugar cannot be adequately controlled.
  • People who are unable to take oral medication, those who are allergic to any ingredient in Huaier granules (the study treatment), or women who are pregnant or breastfeeding.
  • People who misuse drugs, or who have a psychological or psychiatric condition that could affect their ability to follow the study requirements.
  • People whom the researcher considers unsuitable for the trial for any other reason.

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 20 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Zhimin Shao, PhD, Fudan University

Phone: +8618017312288

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 4
Registry
ClinicalTrials.gov
Start date
1 September 2025
Est. completion
1 January 2026

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.

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Recovery rate of any tumor marker (CEA/CA125/CA153) to normal

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: 20 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