Phase 3 Breast Cancer Trial, Recruiting NCT05909332 Sponsor: Fudan University Condition: Breast Cancer
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Phase 3 Breast Cancer Trial, Recruiting

NCT05909332
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 a woman between 18 and 70 years old
  • You are generally able to carry out daily activities with little or no limitation (confirm with trial site for exact fitness level required)
  • Your breast cancer has been confirmed by tissue testing to be triple-negative (meaning it does not respond to certain hormones or a protein called HER2), and belongs to a specific subtype called BLIS
  • Your breast cancer is at a mid-to-advanced stage (Stage IIA to IIIC) that has not spread to other parts of the body, and you have already had surgery to treat it
  • Your blood counts and organ function (such as liver and kidneys) are within acceptable ranges, confirmed by blood tests done within 28 days before starting the trial
  • Your surgical wound has fully healed before the trial begins
  • If you are able to become pregnant, you are willing to use an approved form of contraception during the trial and for at least three months after the last treatment
  • You are willing and able to follow the trial plan and have signed a consent form

Who may not be able to join:

  • You have already received treatment before surgery, such as chemotherapy, targeted therapy, or radiotherapy for this cancer
  • You have cancer in both breasts
  • You have had another type of cancer in the past, unless it was a minor skin cancer or an early-stage cervical condition that was fully treated
  • Your breast cancer has spread to other parts of the body (Stage 4)
  • Your tumor is classified as T4 or above, meaning it involves the skin, is stuck to surrounding tissue, or is the inflammatory type (confirm with trial site)
  • You have serious heart, lung, liver, or kidney problems, including a weakened heart pump (below 50%), a recent major heart or blood vessel event in the past 6 months, poorly controlled diabetes, or severely high blood pressure
  • You are pregnant, breastfeeding, or unable to use effective contraception
  • You are currently taking part in another clinical trial
  • You have a known allergy to a class of chemotherapy drugs called taxanes or their ingredients
  • You have a severe or uncontrolled infection
  • You have a history of substance abuse or a mental health condition that is not well managed
  • The trial doctors have determined for any other reason that the trial is not appropriate for you

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 23 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

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
20 June 2023
Est. completion
30 May 2029

Where this trial is recruiting

🇨🇳 China

Primary endpoints

iDFS

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: 23 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