Phase 2 Breast Cancer Trial, Recruiting NCT06860529 Sponsor: Henan Cancer Hospital Condition: Breast Cancer
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Phase 2 Breast Cancer Trial, Recruiting

NCT06860529
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:

  • Adults aged 18 years or older
  • People diagnosed with breast cancer of a certain size or spread (stages cT2 to cT4, or a smaller tumour that has spread to underarm lymph nodes)
  • People whose breast cancer has been confirmed by biopsy to be hormone receptor-positive (ER and/or PR positive) and HER2-negative, with a high cell growth marker (Ki67 of 20% or above)
  • People with a tumour that can be measured by ultrasound, mammogram, or MRI within one month before joining the trial
  • People whose blood counts and organ function (kidneys, liver, bone marrow) are within acceptable ranges on recent tests taken within one month before starting chemotherapy
  • People with a heart pumping function (LVEF) of 55% or higher, confirmed by an echocardiogram
  • Women who could become pregnant must have a negative blood pregnancy test within 14 days before joining
  • People with a general health and activity level rated as 0 or 1 on the ECOG scale, meaning they are fully active or have only minor limitations in physical activity
  • People who have signed a written consent form agreeing to take part

Who may not be able to join:

  • People whose cancer has spread to other parts of the body (metastatic disease), as confirmed by chest/abdominal scans and bone scans (or a PET/CT scan)
  • People who have already received chemotherapy, hormone therapy, targeted therapy, or radiotherapy for their current breast cancer
  • People who have been diagnosed with another cancer, except for certain treated skin cancers (non-melanoma types)
  • People who have previously received immunotherapy drugs such as anti-PD-1 or anti-PD-L1 treatments (checkpoint inhibitors)
  • People with a known immune system deficiency or an active autoimmune disease
  • People with severe or uncontrolled heart or lung conditions
  • People with active hepatitis B or C where the virus is currently detectable in the blood
  • People who have previously had an organ transplant or bone marrow transplant
  • Women who are currently pregnant or breastfeeding
  • People with other serious uncontrolled health conditions that the trial doctors consider unsuitable for chemotherapy or immunotherapy

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 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: 13603862755

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
Sponsor
Henan Cancer Hospital
Registry
ClinicalTrials.gov
Start date
15 April 2025
Est. completion
31 March 2028

Where this trial is recruiting

🇨🇳 China

Primary endpoints

PCR rate; PCR rate in PDL1 positive subgroup

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