Printed from Voxsanity (voxsanity.com.au) — NCT06000917 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
Back to Breast Cancer
Phase 2 Breast Cancer Trial, Recruiting
NCT06000917
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:
- Women aged 18 to 75 years who are starting treatment for breast cancer for the first time
- People with a general health status that allows them to carry out daily activities with little or no limitation (confirm with trial site regarding the ECOG 0–1 score requirement)
- People whose breast cancer has been confirmed by laboratory testing to be HER2-positive, at an early or locally advanced stage, with a primary tumour size of 2cm or larger, or with cancer that has spread to nearby lymph nodes
- People whose hormone receptor status has been tested and shows that oestrogen receptors are active in at least 10% of cancer cells
- People with healthy blood cell counts, including sufficient white blood cells, platelets, and haemoglobin levels (confirm with trial site for specific values)
- People whose liver and kidney function test results are within acceptable ranges (confirm with trial site for specific values)
- People whose heart pumping function (left ventricular ejection fraction) is at least 55% as measured by heart ultrasound
- People whose heart rhythm test (ECG) shows a QT interval measurement below 470 milliseconds
- Women who are not yet menopausal or have not had surgical sterilisation and who agree to use effective contraception during the trial and for at least 7 months after the last dose
- People who voluntarily agree to take part and sign a consent form
Who may not be able to join:
- People whose breast cancer has spread to other parts of the body (stage IV or metastatic)
- People diagnosed with inflammatory breast cancer
- People who have previously received anti-cancer treatment or radiation therapy for any cancer, except for certain fully treated skin or cervical conditions (confirm with trial site)
- People currently taking part in another clinical trial that includes anti-cancer treatments such as hormone therapy, bone-strengthening therapy, or immunotherapy
- People who had a major surgical procedure unrelated to breast cancer within the 4 weeks before enrolling, or who have not fully recovered from such a procedure
- People with serious heart conditions, including a history of heart failure, weak heart pumping function, uncontrolled rapid heart rhythms, or certain types of heart block (confirm with trial site for specific conditions)
- People who have difficulty swallowing, a bowel obstruction, or any other condition that would prevent proper absorption of the study medication
- People with a known allergy to any ingredients in the study treatment
- People with a history of immune system disorders, a positive HIV test, inherited or acquired immune deficiency conditions, or a history of organ transplantation
- Women who are pregnant, breastfeeding, have a positive pregnancy test at the start of the trial, or are unwilling to use effective contraception throughout the trial and for 7 months after the last dose
- People with other serious health conditions that could interfere with the planned treatment, or anyone the trial doctor considers unsuitable for participation
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.
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: 13971139665
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
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Registry
ClinicalTrials.gov
Start date
11 May 2023
Est. completion
11 May 2025
Where this trial is recruiting
🇨🇳 China
Primary endpoints
total Pathological Complete Response(tPCR)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 7 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.