Printed from Voxsanity (voxsanity.com.au) — NCT07197697 — 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
NCT07197697
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 aged 18 to 75 years, of any gender.
- People whose breast cancer has been confirmed by tissue testing to be hormone receptor-positive and HER2-negative (HR+/HER2-), based on specific international testing guidelines.
- People whose breast cancer tissue is either a high-grade (grade 3) tumour, or a mid-grade (grade 2) tumour where the hormone receptor expression level is between 1% and 10%.
- People whose cancer is at a specific stage based on tumour size and lymph node involvement (T1c–T2c with N1–N2, or T3–T4 with N0–N2, and no distant spread — M0), as classified by international staging guidelines.
- People who have at least one tumour that can be measured using standard imaging criteria (RECIST 1.1).
- People whose expected survival is at least 12 weeks.
- People who are generally able to carry out daily activities with little or no limitation, as rated by a standard medical scale (ECOG performance status 0 or 1).
- People whose blood, liver, kidney, and heart function meet specific thresholds measured within one week before the first treatment, including: adequate red blood cells, white blood cells, and platelets; liver and kidney function values within acceptable ranges; and a heart pumping function (left ventricular ejection fraction) above 50%.
- People whose thyroid-stimulating hormone (TSH) is within the normal range — or, if slightly outside the normal range, whose other thyroid hormone levels (T3 and T4) are normal (confirm with trial site).
- People who are pregnant must have a negative pregnancy test and must agree to use effective contraception throughout the trial period.
- People who voluntarily agree to take part, sign a consent form, and are willing to attend follow-up appointments and cooperate with study 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 with stage IV (metastatic) breast cancer, or whose cancer the researchers consider unable to be treated with pre-surgery therapy followed by full surgical removal.
- People with invasive breast cancer in both breasts at the same time.
- People who have previously received any anti-cancer treatment for breast cancer — such as chemotherapy, hormone therapy, or breast surgery — other than a diagnostic biopsy.
- People who have taken part in another drug clinical trial, had major surgery, an incisional biopsy, or a significant injury within the 4 weeks before enrolling (diagnostic biopsy excluded).
- People who have received a live attenuated vaccine within 4 weeks before the first treatment dose, or who plan to receive one during the study.
- People who have had another type of cancer in the past 5 years, except for certain cancers considered fully cured (such as cervical carcinoma in situ, basal cell skin cancer, squamous cell skin cancer, or papillary thyroid cancer).
- People currently receiving any other anti-cancer treatment at the same time as this trial.
- People with a known allergy to any component of the study drug.
- People with a known history of neurological or psychiatric conditions, including epilepsy or dementia, or a history of substance or drug misuse related to mental health.
- People with a known history of having received a donor organ transplant or donor stem cell transplant.
- People who are pregnant or breastfeeding, or people of reproductive capacity who have a positive pregnancy test at the start of the study.
- People with an active infection at the time of enrolment.
- People diagnosed with an immune deficiency condition, or who are currently receiving steroid treatment or any other medication that suppresses the immune system.
- People with active or potentially recurring autoimmune diseases — except for certain conditions that do not require systemic treatment (such as vitiligo, hair loss, or mild skin conditions), autoimmune thyroid disease managed with stable hormone replacement, or type 1 diabetes managed with a stable insulin dose.
- People with serious health conditions that the investigator considers a safety risk or likely to prevent completion of the study, including (but not limited to) certain lung diseases, severe lung problems, stroke, or severe diabetes.
- People who have experienced any of the following heart or blood vessel conditions within the 6 months before the first treatment: heart attack, unstable chest pain (angina), pulmonary embolism, acute or ongoing reduced blood flow to the heart, stroke, mini-stroke (transient ischaemic attack), or other significant clotting or reduced blood flow events requiring treatment.
- People who have had, or currently have, severe heart failure classified as NYHA grade III or IV.
- People who have had, or currently have, serious irregular heart rhythms requiring medication.
- People whose heart electrical activity test (12-lead ECG) shows a specific measurement (QTcF interval) greater than 470 milliseconds before the first treatment dose.
- People whom the investigator considers unsuitable for participation in this study for any reason.
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: 13805695539
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
Anhui Provincial Cancer Hospital
Registry
ClinicalTrials.gov
Start date
10 October 2025
Est. completion
1 November 2027
Primary endpoints
tpCR rate，total physiological complex response
Can't join this trial?
Data last synced from ClinicalTrials.gov: 21 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.