Phase 2 Breast Cancer Trial, Recruiting NCT06001086 Sponsor: The First Affiliated Hospital with Nanjing Medical University Condition: Breast Cancer
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Phase 2 Breast Cancer Trial, Recruiting

NCT06001086
Recruiting Phase 2

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 aged 18 to 75 years old at the time of signing the consent form, of any gender
  • People who have been diagnosed with HER2-positive early breast cancer, confirmed through a tissue sample (biopsy) tested in a local laboratory using standard guidelines
  • People with a single tumor, or multiple tumors in the same area of the breast, where at least one tumor has been tested and confirmed as HER2-positive
  • People with tumors in more than one area of the breast, where one tumor from each affected area has been tested and confirmed as HER2-positive by a central laboratory
  • People whose tumor is either hormone receptor-positive or hormone receptor-negative (meaning the tumor tests negative for both ER and PgR)
  • People whose breast cancer has been staged as Stage II to Stage IIIC based on breast X-ray or MRI imaging, using standard cancer staging guidelines
  • People who have had their lymph nodes assessed by a needle biopsy, if applicable
  • People who are in good general physical condition at the time of joining the trial, rated as fully active or with only minor limitations (confirm with trial site)

Who may not be able to join:

  • People who have previously had invasive breast cancer
  • People whose breast cancer has spread to other parts of the body (Stage IV)
  • People who have had any other cancer in the past 3 years, except for certain fully removed skin cancers or some types of early-stage cancer that have been completely cured
  • People who have a history of a non-invasive breast condition called DCIS (ductal carcinoma in situ), unless their only treatment for it was complete surgical removal of the breast
  • People who have serious or uncontrolled health conditions that the trial doctors believe could make participation unsafe or affect the person's ability to follow the trial requirements — this may include uncontrolled high blood pressure, serious ongoing infections, a history of kidney transplant, active bleeding conditions, or severe ongoing digestive problems involving diarrhea
  • People who currently have an infection that requires treatment through an intravenous (IV) drip, such as IV antibiotics, antiviral, or antifungal medicines

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 2: approximately ~30% 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: 025-68307102

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 2
Registry
ClinicalTrials.gov
Start date
1 November 2023
Est. completion
1 August 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

pathologic complete response(pCR)

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