Phase 3 Breast Cancer Trial, Recruiting NCT05806060 Sponsor: Fudan University Condition: Breast Cancer
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Phase 3 Breast Cancer Trial, Recruiting

NCT05806060
Recruiting Phase 3

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 with a good general activity level, rated 0 or 1 on a standard medical scale (meaning able to carry out daily activities with little or no restriction)
  • People with a life expectancy of at least three months
  • People who have been diagnosed with triple-negative breast cancer (a type that lacks three specific proteins: HER2, ER, and PR) that has spread or cannot be surgically removed, and whose cancer is of a specific subtype called BLIS
  • People whose breast cancer has come back or spread to other parts of the body, where surgery to fully remove it is not possible
  • People who have not previously received chemotherapy or targeted therapy for metastatic triple-negative breast cancer
  • People who have at least one tumour area that can be measured or tracked using standard imaging criteria, and that has not previously been treated with radiation
  • People whose major organs (such as heart, liver, and kidneys) are functioning at a broadly normal level
  • Women who could potentially become pregnant and who agree to either avoid sexual intercourse with men or use contraception as specified for their treatment group during the trial
  • People who are able to understand what the trial involves and are willing to take part 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 cancer that has spread to the brain or spinal cord and is causing symptoms, has not been treated, or is getting worse
  • People with serious heart or blood vessel disease
  • People who are still experiencing side effects of grade 1 or higher from previous cancer treatments (except hair loss, or other exceptions decided by the research team)
  • People who have had major surgery within 3 weeks before starting the trial (minor procedures such as fitting a port for medication are generally excepted)
  • People who are pregnant, breastfeeding, or planning to become pregnant during the study
  • People who have had another cancer within the past 5 years, except for certain fully treated skin cancers or early-stage cervical cancer that has been cured
  • People who have difficulty swallowing, ongoing severe diarrhoea, or bowel blockage, or other conditions that would significantly affect how the body absorbs the trial medication
  • People who have a build-up of fluid in body cavities (such as around the lungs or in the abdomen) that cannot be controlled by drainage or other treatments
  • People who have taken part in another cancer drug clinical trial within 4 weeks before starting this trial
  • People with wounds that have not healed over a long period, or fractures that have not fully healed
  • People with a known active hepatitis B or C infection, or abnormal liver function related to hepatitis
  • People with a known allergy to any of the drugs used in this trial, or a history of allergic reactions to similar antibody-based medicines
  • People who have had gastrointestinal bleeding or signs of significant bleeding risk in the past 6 months (such as certain oesophageal vein problems, active ulcers, or specific stool test results); people with a lower level of blood detected in stool may require further stomach investigation before eligibility can be confirmed (confirm with trial site)
  • People who have had an abdominal fistula, bowel perforation, or abdominal abscess in the 28 days before joining the trial
  • People with a high level of protein in their urine above specified thresholds
  • People with high blood pressure that remains above 140/90 mmHg even after taking blood pressure medication

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

Contact this trial

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
25 April 2023
Est. completion
1 May 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

PFS

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