Phase 3 Breast Cancer Trial, Recruiting NCT03201861 Sponsor: RenJi Hospital Condition: Breast Cancer
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Phase 3 Breast Cancer Trial, Recruiting

NCT03201861
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:

  • Women between 18 and 70 years of age
  • People who have agreed to surgery and have been diagnosed with early-stage breast cancer confirmed by a tissue sample, specifically an invasive type
  • People who have not received any treatment for breast cancer before their surgery
  • People with triple-negative breast cancer confirmed by laboratory testing, OR people with hormone receptor-positive breast cancer who also meet at least one of these conditions: cancer has spread to underarm lymph nodes; tumour is 2 cm or larger AND a cell-growth marker called Ki-67 is above 20%; tumour is 2 cm or larger AND the cancer is graded as the most aggressive level (Grade III); or tumour is 2 cm or larger AND the person is under 35 years old
  • People whose cancer tests negative for the HER2 protein, confirmed by specific laboratory methods
  • People who are in generally good physical health, able to carry out normal daily activities with little or no limitation (confirm with trial site what scoring level this means for you)
  • People whose blood counts and organ function levels fall within acceptable ranges, including white blood cells, platelets, haemoglobin, liver function markers, and kidney function markers
  • People with no significant problems with major organ function

Who may not be able to join:

  • People whose breast cancer has spread to other parts of the body (metastatic breast cancer)
  • People who are pregnant or currently breastfeeding
  • People who have signs of nerve damage affecting sensation or movement
  • People who have breast cancer in both breasts at the same time (having a non-invasive condition called DCIS in one breast does not automatically exclude a person — confirm with trial site)
  • People who have other medical conditions that make chemotherapy unsafe, such as uncontrolled heart or blood vessel disease, or serious infection
  • People who have previously received chemotherapy for any cancer other than breast cancer
  • People with a known serious allergic reaction to any of the medications used in this trial

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 26 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: Jinsong Lu, M.D., Shanghai Jiao Tong University School of Medicine

Phone: 86-21-68385569

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
Registry
ClinicalTrials.gov
Start date
27 July 2017
Est. completion
31 August 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Number of Participants With Disease-Free Survival (DFS) Events

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: 26 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