Phase 4 Breast Cancer Trial, Recruiting NCT06230055 Sponsor: Fudan University Condition: Breast Cancer
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Phase 4 Breast Cancer Trial, Recruiting

NCT06230055
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 18 or older, of any gender
  • People who are able to understand the purpose, benefits, and risks of the trial and are willing to sign a consent form
  • People whose general physical health and ability to carry out daily activities falls within an acceptable range, as measured by a standard oncology scoring tool (ECOG score of 3 or below)
  • People who have been diagnosed with HER2-negative metastatic breast cancer, confirmed through tissue or cell testing (HER2-negative is defined by specific laboratory test results — confirm with trial site)
  • People whose cancer has not responded to standard treatments, or who have been unable to tolerate standard treatments
  • People who have leptomeningeal (pial) metastasis — meaning cancer that has spread to the lining around the brain and spinal cord, confirmed either by finding cancer cells in the cerebrospinal fluid, or by symptoms and a specific pattern seen on a brain MRI
  • People whose major organs (blood, kidneys, liver, and clotting system) are functioning at an acceptable level, confirmed by blood tests during screening
  • People whose heart function falls within an acceptable range, with no significant abnormalities on a heart tracing (ECG)
  • People who are willing to follow the trial schedule and attend regular follow-up appointments
  • People of childbearing potential who are not planning to become pregnant or donate sperm during the trial and for 6 months after the last dose, or who are using effective contraception; women of childbearing age must have a negative pregnancy test within 7 days before joining
  • People who have recovered sufficiently from side effects of their most recent treatment before starting the trial, as determined by the investigating doctor

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 are pregnant or breastfeeding
  • People who have an active acute or chronic infection, or another serious illness that the investigating doctor considers makes participation unsuitable
  • People who have had another cancer within the past 5 years (with some exceptions, such as certain fully treated skin, cervical, or thyroid cancers — confirm with trial site)
  • People with a mental illness or condition that would make it difficult to cooperate with the trial or accurately report responses to treatment
  • People with serious organ disease or major organ failure, such as severe heart or lung failure, that would make treatment difficult to tolerate
  • People who have a tendency to bleed
  • People who have had an organ transplant
  • People who have been taking steroid (corticosteroid) medications or immune-suppressing medications on a long-term basis
  • People who have had bleeding inside the skull that is not related to their cancer
  • People who have complications in the brain or nervous system that require urgent treatment
  • People from whom cerebrospinal fluid (the fluid around the brain and spinal cord) cannot be collected (applies to the treatment group)
  • People with a history of immune deficiency, including a positive HIV test, or any other acquired or inherited immune deficiency condition
  • People with active hepatitis B or hepatitis C (specific test thresholds apply — confirm with trial site; people with stable chronic hepatitis receiving standard antiviral treatment may still be eligible)
  • People with serious heart conditions or symptoms, including heart failure, unstable chest pain (angina), a heart attack within the past 6 months, certain significant abnormal heart rhythms, a significantly prolonged heart electrical interval (QTcF), or poorly controlled high blood pressure
  • People whom the investigating doctor 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 30 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

Phone: +8664175590

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 4
Registry
ClinicalTrials.gov
Start date
5 January 2024
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

Neural progression-free survival (NPFS)

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: 30 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