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Phase 2 Breast Cancer Trial, Not Yet Recruiting
NCT07618923
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
- Adults aged 18 to 70 years old.
- People with a laboratory-confirmed diagnosis of invasive breast cancer that is hormone receptor-positive (the cancer responds to certain hormones) and HER2-low (a specific level of a protein found on cancer cells).
- People who have not previously received any systemic drug treatment for breast cancer.
- People whose breast cancer is classified as Stage II or Stage III according to a standard medical staging system (confirm with trial site for exact staging details).
- People who have at least one of the following risk factors: cancer that has spread to one or more lymph nodes under the arm; a tumour measuring 2 cm or larger; a tumour graded as Grade 3 (fast-growing); or a Ki-67 score of 20% or higher (a measure of how quickly cancer cells are dividing).
- People who have at least one tumour that can be measured using standard imaging criteria.
- People who are largely able to carry out daily activities, with little or no limitation due to illness (ECOG performance score of 0 or 1).
- People whose blood counts, liver, kidney, heart, and lung function all meet minimum health thresholds as determined by the trial site through standard tests.
- Women who could become pregnant must have a negative pregnancy test before starting and must agree to use reliable contraception during treatment and for 6 months after treatment ends.
- People who are willing and able to give informed consent and follow the requirements of the study.
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 breast cancer has not been confirmed through a tissue sample (pathology test).
- People with bilateral breast cancer (affecting both breasts), inflammatory breast cancer, or occult breast cancer (where the primary tumour cannot be found).
- People who have previously received any cancer treatment, including chemotherapy, radiation, targeted therapy, or hormone therapy.
- People currently receiving any other cancer treatment at the same time as this trial.
- People who have had another cancer in the past 5 years, except for certain skin cancers or early-stage cervical changes that have been fully treated and cured.
- People who have participated in another interventional clinical trial within 4 weeks before the first dose.
- People who have taken immune-suppressing medications or high-dose steroid medicines (more than 10 mg per day of prednisone or equivalent) within 2 weeks before the first dose.
- People who have received a live or attenuated (weakened) vaccine within 4 weeks before the first dose.
- People who have had major surgery unrelated to breast cancer within 4 weeks before the first dose.
- People with an active autoimmune disease, or a history of autoimmune disease that required ongoing treatment.
- People known to have a weakened immune system (for example, HIV-positive) or who have previously had an organ transplant.
- People with serious or uncontrolled heart conditions, such as severe heart failure, a recent heart attack, unstable chest pain, certain abnormal heart rhythms, or uncontrolled high blood pressure.
- People with known or suspected lung inflammation (interstitial lung disease) or other significant pre-existing lung conditions.
- People with active hepatitis B or hepatitis C infections at certain levels, liver cirrhosis, or a serious uncontrolled infection.
- People with a known tendency to bleed or to develop blood clots.
- People with a known allergy or medical reason to avoid any of the study drugs or their ingredients.
- People who are pregnant, breastfeeding, or who have a positive pregnancy test at the start of the trial.
- People with any other condition that the trial team considers may affect their safety or ability to participate, such as uncontrolled high blood pressure, severe diabetes, or active infection.
- People with a history of significant neurological or psychiatric conditions (such as epilepsy or dementia), or anyone the investigator considers unsuitable for the trial for any other 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.
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Trial details
Status
Not Yet Recruiting
Phase
Phase 2
Sponsor
Tang-Du Hospital
Registry
ClinicalTrials.gov
Start date
1 June 2026
Est. completion
1 June 2028
Primary endpoints
Objective Response Rate (ORR)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 8 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.