Printed from Voxsanity (voxsanity.com.au) — NCT07054242 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 2 Breast Cancer Trial, Not Yet Recruiting
NCT07054242
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
- People diagnosed with stage II or III triple-negative breast cancer (a specific type of breast cancer that lacks three particular receptors), confirmed through laboratory testing of tissue samples.
- The cancer must have tested as having very low levels of estrogen and progesterone receptors (less than 1%) on laboratory analysis.
- The cancer must have tested negative for a protein called HER2, following specific 2028 testing guidelines.
- A stored tumour tissue sample must be available for research testing.
- People who have at least one tumour that can be measured using standard imaging criteria.
- People who are generally well enough to carry out daily activities with little or no limitation, as assessed by a standard medical scale (ECOG score of 0 or 1).
- People whose blood tests show that the bone marrow, liver, kidneys, and other organs are working well enough — including adequate levels of blood cells, and normal or near-normal results for liver, kidney, thyroid, and heart enzyme tests (all without recent blood transfusions or certain medical supports in the 14 days before testing).
- People who have not received any cancer treatment for their current breast cancer diagnosis.
- Women who could become pregnant, and men whose partners could become pregnant, who agree to use effective contraception from the start of the trial until six months after treatment ends.
- People who are willing and able to follow all study procedures and who provide written agreement to participate.
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 heart is pumping below 50% of its normal capacity, or who have significant heart failure (classified as severe by a standard heart disease scale).
- People who have already received chemotherapy, targeted therapy, or radiotherapy for their current breast cancer.
- People who have previously been treated with certain immune system drugs known as checkpoint inhibitors (such as anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapies) or other treatments that directly target certain immune cells.
- People who have previously received therapy targeting a protein called Trop-2, or a type of chemotherapy called topoisomerase I inhibitors.
- People who have had another cancer within the past five years, with the exception of certain treated, low-risk cancers such as cervical carcinoma in situ, basal cell skin cancer, or certain skin squamous cell cancers.
- People with serious eye surface conditions, such as severe dry eye, certain eyelid gland disorders, or corneal problems that affect healing.
- People with a known allergy or sensitivity to any ingredient in the study drug.
- People with a history of immune system deficiency disorders or who have received an organ transplant.
- People with a current or past history of lung inflammation (pneumonitis or interstitial lung disease) that has required steroid treatment, or where signs of this condition are still visible on recent scans.
- People with significant lung conditions, including a blood clot in the lungs within the past three months, severe asthma, severe chronic obstructive pulmonary disease (COPD), severe restrictive lung disease, fluid around the lungs requiring medical drainage, connective tissue disease affecting the lungs, or previous surgical removal of a lung.
- People with an active autoimmune disease that has required systemic (whole-body) medical treatment within the past two years — with the exception of hormone replacement therapy or low-dose corticosteroids taken to replace hormones the body does not produce.
- People with an active infection that requires systemic (whole-body) treatment within 14 days before starting the trial.
- People with other serious health conditions that, in the trial team's judgement, could put them at risk or affect how well the trial can be run or interpreted.
- People with any other condition that the trial investigator believes could affect how the study drug is evaluated, compromise safety monitoring, interfere with results, or otherwise make participation unsuitable.
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.
Contact this trial
Phone: China: 0535-6691999-81603
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
Yantai Yuhuangding Hospital
Registry
ClinicalTrials.gov
Start date
30 October 2025
Est. completion
30 October 2026
Where this trial is recruiting
🇨🇳 China
Primary endpoints
Pathological complete response rate (pCR: ypT0/is, ypN0)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 9 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.