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Phase 2 Breast Cancer Trial, Not Yet Recruiting
NCT06731153
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 between 18 and 70 years old (inclusive).
- People with a performance status score of 0, 1, or 2 on a standard scale used by doctors to measure how much a person's cancer affects their daily activities (ECOG scale).
- People who have triple-negative breast cancer (TNBC) that has spread to other parts of the body or has grown into nearby tissues, confirmed by tissue testing.
- People whose breast cancer has been confirmed by tissue testing to be negative for three specific markers: estrogen receptor (ER-), progesterone receptor (PR-), and HER2 receptor (HER2-).
- People who have scan or imaging evidence showing their cancer has come back or continued to grow after receiving immunotherapy (a type of cancer treatment using anti-PD-1 or anti-PD-L1 antibodies) for metastatic breast cancer.
- People whose cancer did not respond to anti-PD-1 or anti-PD-L1 immunotherapy, and who have no ongoing side effects from those previous treatments.
- People who have at least one area of cancer that can be measured on scans, according to a standard set of measurement rules (RECIST 1.1).
- People with a life expectancy of at least 3 months.
- People whose main organ functions are within acceptable ranges, including blood counts (haemoglobin, white blood cells, and platelets), liver and kidney function, blood protein levels, blood clotting measures, and heart function — all meeting specific values the trial doctors will assess.
- People who have not received radiotherapy, targeted cancer therapy, or surgery within the 3 weeks before starting the trial, and who have recovered from any side effects of previous treatment (including fully healed surgical wounds), with no or only mild nerve-related side effects.
- Women who are able to become pregnant must use a medically approved form of contraception during the trial and for at least 3 months after the last dose of the study drug.
- People who are willing to join the study voluntarily, have signed a consent form, are able to follow the study requirements, and are willing to attend follow-up appointments.
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 active cancer spread to the brain, cancer affecting the lining of the brain or spinal cord, or a primary brain tumour that has not been treated with surgery or radiotherapy (those whose brain condition has been stable for at least 4 weeks after treatment and who have been off steroids for more than 2 weeks may still be considered).
- People with a history of an active autoimmune disease (where the immune system attacks the body) or one that may come back — with exceptions for well-controlled type 1 diabetes, thyroid conditions managed only with hormone replacement, well-controlled coeliac disease, or certain skin conditions not needing systemic treatment (such as vitiligo, psoriasis, or hair loss).
- People who have previously been treated with the drug Eribulin.
- People who have had another active cancer within the past 2 years, other than the breast cancer being studied in this trial, or certain treated skin or cervical cancers that have been fully removed or cured.
- People with an active autoimmune disease, a condition requiring ongoing steroid or immune-suppressing medication, a history of HIV infection or other immune deficiency conditions, or a history of organ or bone marrow transplant.
- People who have used corticosteroid (steroid) medication within 14 days before the first dose of the study drug.
- People with uncontrolled diabetes, severely low blood protein levels (grade 3 or higher), or significantly abnormal levels of potassium, sodium, or calcium in the blood (above grade 1) within 14 days before the first dose, despite standard treatment.
- People with a history of lung disease affecting the tissue of the lung itself (such as interstitial lung disease, non-infectious lung inflammation, pulmonary fibrosis, or acute lung conditions).
- People who have needed systemic antibiotic, antifungal, or antiviral treatment for a serious or active infection (including tuberculosis) within 14 days before the first dose — though antiviral treatment for viral hepatitis is permitted.
- People with an active serious psychiatric condition such as schizophrenia, major depression, or bipolar disorder (note: depression being managed with antidepressants is not an exclusion).
- People with untreated chronic hepatitis B, or hepatitis B carriers with a high level of the virus in their blood (HBV DNA above 500 IU/mL), or people with active hepatitis C with detectable virus levels (those with stable, treated hepatitis B with low viral levels may still be considered).
- People who have had major surgery requiring general anaesthesia within 28 days before the first dose.
- People who have previously received an allogeneic stem cell transplant or organ transplant.
- People who have had any of the following heart or blood vessel conditions: chest pain from a heart cause within the past 28 days; a symptomatic blood clot in the lungs within the past 28 days; a heart attack within the past 6 months; heart failure at a serious level (NYHA grade III or IV) within the past 6 months; a significant abnormal heart rhythm within the past 6 months; a stroke or similar event within the past 6 months; a QT interval on a heart tracing above 450 ms; fainting or seizures within the past 28 days; or poorly controlled high blood pressure (systolic above 150 mmHg and/or diastolic above 100 mmHg).
- People who are known to have a sensitivity or allergic reaction to ivarmacitinib or any of the ingredients in its formulation.
- People who have received systemic chemotherapy within 28 days before the first dose, or immunotherapy, hormone therapy, targeted therapy, or any other investigational treatment within 14 days or within 5 half-lives of the drug (whichever is shorter).
- People who have used any Chinese herbal medicine or traditional Chinese medicine with anti-cancer activity (as approved by the Chinese national drug authority) within 14 days before the first dose.
- People who still have side effects from previous cancer treatments that have not returned to their baseline or stabilised, unless the side effect is not considered a safety concern (for example, hair loss, nerve-related symptoms, or certain minor lab changes).
- People who have received a live vaccine within 28 days before starting the trial (standard inactivated flu vaccines are allowed; nasal spray flu vaccines, which are live, are not).
- People with an underlying health condition, or alcohol or drug dependence, that could interfere with taking the study drug safely or make it difficult to assess the drug's effects or side effects.
- People who are currently participating in another clinical trial involving an active treatment (observational studies or the follow-up phase of a past interventional study are permitted).
- People who are unable to swallow capsules, or who have conditions that significantly affect the digestive system's ability to absorb medication, such as malabsorption syndrome, removal of the stomach or small intestine, weight-loss surgery, inflammatory bowel disease, or a bowel blockage.
- People with uncontrolled fluid build-up around the lungs, heart, or abdomen that has required drainage or medical treatment within 7 days before the first dose, and where the fluid has returned significantly within 2 weeks of that treatment.
- People who are 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.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Status
Not Yet Recruiting
Phase
Phase 2
Sponsor
Registry
ClinicalTrials.gov
Start date
1 December 2024
Est. completion
1 June 2027
Where this trial is recruiting
🇨🇳 China
Primary endpoints
Safety run-in: Incidence rate of dose-limiting toxicities (DLTs); Safety run-in: adverse events (AEs); Safety run-in: Serious adverse events (SAEs); Objective response rate (ORR)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 17 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.