Phase 2 Breast Cancer Trial, Not Yet Recruiting NCT04158856 Sponsor: xuexin he Condition: Breast Cancer
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Phase 2 Breast Cancer Trial, Not Yet Recruiting

NCT04158856
Not Yet Recruiting Phase 2

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not 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 may be able to join

  • Women between 18 and 70 years old
  • People who have completed surgery to fully remove the tumour (radical surgery)
  • People whose breast cancer has been confirmed by laboratory testing as a specific type called invasive ductal carcinoma
  • People whose tumour was smaller than 8mm, had not spread to the lymph nodes, and showed no signs of spreading elsewhere in the body
  • People whose removed tumour tissue has been tested and found to be HER2-positive (a specific protein marker on cancer cells) at a high level, with a nuclear grade of 3 (confirm with trial site for exact testing details)
  • People who have enough tumour tissue available for multiple tissue samples to be taken
  • People for whom fewer than 84 days have passed since their surgery, and whose surgical wound has healed adequately as assessed by their treating doctor
  • People who are in good general health, able to carry out daily activities with little or no limitation (ECOG score 0–1), and expected to live longer than 12 months
  • People whose heart is functioning normally, with a heart pumping strength (LVEF) of 50% or above, confirmed by a heart scan or ultrasound
  • People with adequate bone marrow, liver, kidney, and blood clotting function
  • Women who could become pregnant must have a negative pregnancy test within 7 days of starting the study drug, and must agree to use an effective form of contraception throughout the study
  • People who have given written informed consent in line with local ethics committee requirements

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • People whose tumour was 8mm or larger, or whose cancer had spread to the lymph nodes
  • People whose breast cancer has spread to other parts of the body (metastatic breast cancer)
  • People who have previously received any systemic or localised treatment for breast cancer, including chemotherapy within the past 28 days
  • People with a history of another cancer, except for certain early-stage cervical cancer or a type of non-spreading skin cancer (basal cell carcinoma)
  • People with medical conditions that may make it unsafe to receive the treatments used in this trial, such as severe infection, active stomach ulcers, blood clotting disorders, connective tissue disease, or conditions affecting bone marrow
  • People experiencing significant nerve damage in their hands or feet (peripheral neuropathy above grade 2 on a standard medical scale)
  • People with a known severe allergic reaction to any of the drugs used in this study
  • People with heart or lung problems, including moderate-to-severe heart failure, chest pain requiring medication, a previous heart attack, significant blood vessel disease, uncontrolled abnormal heart rhythms, or uncontrolled high blood pressure
  • People with active hepatitis B or hepatitis C along with abnormal liver function test results, or people known to be HIV positive
  • People who are currently pregnant or breastfeeding

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 13 July 2026

Contact this trial

Principal Investigator: Xuexin He, MD, Seaond Affiliated Hospital, Zhejiang University, School of Medicine

Phone: +86-18329139569

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
Not Yet Recruiting
Phase
Phase 2
Sponsor
xuexin he
Registry
ClinicalTrials.gov
Start date
1 June 2020
Est. completion
31 May 2023

This date has passed while the registry still lists the trial as open to participants. Sponsors often update a trial's status without revising its projected end date, so it may well still be recruiting — but the record is out of date in at least one respect. Check with the study contact before relying on either.

Primary endpoints

Disease-free Survival

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: 13 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