Phase 3 Breast Cancer Trial, Recruiting NCT05760378 Sponsor: Fudan University Condition: Breast Cancer
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Phase 3 Breast Cancer Trial, Recruiting

NCT05760378
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:

  • You are generally active and able to carry out daily activities with little to no limitation (as measured by a standard scale called ECOG 0-1)
  • Your doctors expect you to live for at least three more months
  • You have been diagnosed with a type of breast cancer called triple-negative breast cancer (TNBC), confirmed by a tissue sample, that has spread to other parts of the body or cannot be surgically removed
  • Your cancer has either come back or spread, and any local return of the cancer has been confirmed by doctors as unable to be fully removed by surgery
  • Your blood counts and organ functions (such as liver and kidneys) are within acceptable ranges based on lab tests
  • Your cancer can be measured on scans according to standard medical guidelines
  • You have not previously received chemotherapy or targeted therapy for your metastatic triple-negative breast cancer

Who may not be able to join:

  • You have previously been treated with certain drugs that block blood vessel growth (called anti-VEGFR tyrosine kinase inhibitors), such as famitinib, sorafenib, sunitinib, or regorafenib
  • You have a history of bleeding problems or have had a serious bleeding event in the past
  • Your tumor is located near major blood vessels, creating a high risk of bleeding
  • You have problems with blood clotting
  • You have had a blood clot in an artery or vein
  • You have a history of an autoimmune disease (where the immune system attacks the body)
  • You have tested positive for HIV
  • You currently have active hepatitis B or hepatitis C
  • You have uncontrolled fluid build-up around the lungs or in the abdomen
  • You have a known disease affecting the brain or spinal cord
  • You have a wound that has not healed for a long time, or a bone fracture that has not fully healed
  • Your urine protein levels are above a certain level on tests (confirm with trial site)
  • You are currently pregnant or breastfeeding
  • You have a thyroid condition that is not well controlled (confirm with trial site)
  • You have nerve damage or numbness/weakness in your hands or feet that is moderate or severe
  • You have high blood pressure that is not well controlled
  • You have a history of unstable chest pain (unstable angina)
  • You have recently been diagnosed with chest pain caused by reduced blood flow to the heart (new angina)
  • You have had a heart attack

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 2 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.

GP referral letter

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Trial details

Status
Recruiting
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
17 March 2023
Est. completion
1 January 2025

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: 2 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