Breast Cancer Trial, Recruiting NCT04281641 Sponsor: Fudan University Condition: Breast Cancer
Back to Breast Cancer

Breast Cancer Trial, Recruiting

NCT04281641
Recruiting Not Applicable

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 presenting for the first time with operable breast cancer, with no previous treatment for any invasive cancer (male or female).
  • People whose primary breast tumor is larger than 2 cm in diameter.
  • People aged 18 years or older and under 70 years of age.
  • People with a general health/activity level rated at 0 or 1 on a standard medical scale, meaning they are fully active or restricted in strenuous activity but able to carry out light work (confirm with trial site).
  • People whose heart pumping function (left ventricular ejection fraction) is measured at 55% or above.
  • People for whom a tumor tissue sample will be available after surgery.
  • People who agree to have a needle biopsy taken for genetic testing and a laboratory drug sensitivity test.
  • People whose breast cancer has been confirmed through tissue examination under a microscope.
  • People whose cancer tests positive for a protein called HER2, either by a specific staining test (IHC 3+) or by a gene amplification test (FISH).
  • People who have had their hormone receptor status (ER and PgR) tested.
  • People who have signed a consent form agreeing to take part.
  • People who are able to follow the requirements of the trial protocol.

Who may not be able to join:

  • People whose cancer has spread to other parts of the body (Stage IV), or who have cancer in both breasts.
  • People who have previously received any systemic cancer treatment, including chemotherapy, immunotherapy, HER2-targeted therapy, or cancer vaccines, or who have had radiation therapy for cancer.
  • People who have had a previous breast or any other cancer diagnosis within the past 5 years.
  • People with poor bone marrow, kidney, or liver function.
  • People with a history of or current heart or cardiovascular condition.
  • People with a severe or uncontrolled illness affecting the whole body.
  • People with poorly managed diabetes or signs of serious diabetes-related complications affecting blood vessels.
  • People who are pregnant or breastfeeding.
  • People who received any experimental treatment within 4 weeks before the trial start date.
  • People with a known infection with HIV, hepatitis B, or hepatitis C.
  • People currently taking corticosteroid tablets daily at a dose higher than 10 mg of methylprednisolone or an equivalent dose (not including inhaled steroids).
  • People with a known allergy or sensitivity to any of the medications or ingredients used in the 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 28 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: +862164175590

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
Not Applicable
Registry
ClinicalTrials.gov
Start date
21 April 2020
Est. completion
30 April 2025

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Percent Change in Standardized Uptake Value (SUV) on Positron Emission Tomography and Change in Gene Expression With Response

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: 28 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