Phase 3 Breast Cancer Trial, Recruiting NCT04547907 Sponsor: Henan Cancer Hospital Condition: Breast Cancer
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Phase 3 Breast Cancer Trial, Recruiting

NCT04547907
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 aged 18 to 70 years old
  • People with a certain stage of breast cancer (classified as T2–T4d, or T1c with cancer that has spread to the lymph nodes in the armpit)
  • People whose breast cancer has been confirmed by a tissue sample (biopsy) to be HER2-positive, based on specific laboratory tests
  • People who have at least one area of cancer that can be measured by ultrasound, mammography, or MRI within 1 month before joining the trial
  • People whose blood test results within 1 month before treatment show that the bone marrow and organs are working well enough for chemotherapy (specific thresholds apply — confirm with trial site)
  • People whose heart scan (echocardiogram) shows the heart is pumping at 55% or more of its capacity
  • Women of childbearing age who have a negative blood pregnancy test within 14 days before joining
  • People with a general health status rated as fully active or able to carry out light work (ECOG score of 0 or 1)
  • People who have signed a form giving their informed consent to take part

Who may not be able to join:

  • People whose breast cancer has spread to other parts of the body (stage IV or metastatic)
  • People who have cancer in both breasts
  • People who have already received chemotherapy, hormone therapy, targeted therapy, or radiotherapy for this breast cancer
  • People who have had another separate cancer, unless it was a skin cancer that was fully treated
  • People who had a major surgery unrelated to breast cancer within the 4 weeks before enrolling, or who have not fully recovered from such a surgery
  • People with serious heart conditions, including a history of heart failure, dangerous irregular heartbeats, chest pain requiring medication, significant heart valve problems, evidence of a previous full-thickness heart attack on an ECG, or uncontrolled high blood pressure (above 180/100 mmHg)
  • People with other severe or uncontrolled medical conditions that the trial doctor considers would make chemotherapy unsafe
  • People with a known allergy to any of the study drugs, a history of immune deficiency conditions (including HIV), other immune system disorders, or a history of organ transplantation

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

Principal Investigator: Zhenzhen Liu, Study Principal Investigator Henan Cancer Hospital

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 3
Sponsor
Henan Cancer Hospital
Registry
ClinicalTrials.gov
Start date
18 September 2020
Est. completion
31 December 2024

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Pathological 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: 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