Phase 3 Breast Cancer Trial, Recruiting NCT04722978 Sponsor: Sun Yat-Sen University Cancer Center Condition: Breast Cancer
Back to Breast Cancer

Phase 3 Breast Cancer Trial, Recruiting

NCT04722978
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:

  • People with a performance status score of 0 or 1 on the ECOG scale, meaning they are fully active or have only minor limitations in physical activity (confirm with trial site)
  • People whose breast cancer has been confirmed by laboratory testing to be invasive ductal carcinoma, no specific type (NOS)
  • People whose cancer has tested negative for oestrogen receptors (ER), progesterone receptors (PR), and HER2 — a combination sometimes called "triple-negative" breast cancer
  • People who have not yet received any treatment after their cancer has come back or spread to other parts of the body
  • People who have at least one tumour or lesion that can be measured on a scan, according to standard medical criteria
  • People whose blood test shows a specific ratio of immune cells (neutrophils to lymphocytes) of 2 or above
  • People whose heart, kidneys, liver, and bone marrow are all functioning at an adequate level, including a heart pumping function of at least 45% on an echocardiogram
  • People who are willing and able to follow the study requirements
  • People who have given written, signed consent to participate

Who may not be able to join:

  • People who are pregnant or breastfeeding
  • People who have a confirmed BRCA gene mutation, or whose cancer tests positive for PD-L1, or shows signs of a specific type of genetic instability known as MSI-H or mismatch repair deficiency (dMMR)
  • People who are currently receiving or plan to receive other biological therapies or immunotherapy treatments
  • People who have other medical conditions that are not well controlled
  • People who have signs of an active infection, whether recent or ongoing
  • People who have heart, kidney, liver, or bone marrow problems that do not meet the required function levels (confirm with trial site)
  • People who currently have another cancer, or have been diagnosed with a different cancer within the past five years
  • People who have had a serious allergic reaction to the antibiotic moxifloxacin
  • People who are unable or unwilling to follow the requirements of the study program

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 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.

Contact this trial

Principal Investigator: Zhong-yu Yuan, M.D., Sun Yat-sen University

Phone: 862087342794

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
Sponsor
Sun Yat-Sen University Cancer Center
Registry
ClinicalTrials.gov
Start date
20 April 2021
Est. completion
1 June 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

progression-free survival (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: 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