Phase 2 Breast Cancer Trial, Not Yet Recruiting
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 who have given written informed consent to participate.
- Women aged 18 years or older.
- People who have a good general physical functioning level, rated 0 or 1 on a standard oncology fitness scale (confirm with trial site).
- People with a life expectancy of more than six months.
- People diagnosed with HER2-negative metastatic breast cancer.
- People who have at least one measurable area of cancer that can be tracked using standard imaging criteria.
- People with hormone receptor (HR)-positive, HER2-negative metastatic breast cancer who have received first-line hormone-based therapy, either alone or combined with a CDK4/6 inhibitor.
- People who received certain chemotherapy treatments (anthracyclines or taxanes) at an earlier stage and whose cancer came back or spread more than 6 months after their last dose of those treatments.
- People with HR-positive disease for whom first-line hormone therapy is considered appropriate by the treating doctor.
- People with good overall organ function.
- Women who could become pregnant must have a negative blood pregnancy test within 7 days before starting study treatment, and must use effective contraception from screening until 180 days after the last dose.
- Women must agree not to breastfeed during the study or for 180 days after the last dose of study treatment.
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 who have previously received Eribulin, immunotherapy, or other chemotherapy during the metastatic stage of their illness.
- People who are currently enrolled in another interventional clinical trial, or who received an investigational treatment within 4 weeks (or within 5 half-lives of the drug, whichever is longer) before starting this study.
- People who received radiation therapy covering more than 20% of their bone marrow within 2 weeks before starting treatment, except for minor palliative radiation given more than one week before the first study day.
- People experiencing a severe internal organ crisis that requires immediate chemotherapy.
- People with a known allergy to Eribulin or Sintilimab (the study drugs).
- People who received a blood transfusion (platelets or red blood cells) within 4 weeks before starting treatment.
- People who received growth factor injections (such as G-CSF or erythropoietin) within 4 weeks before starting treatment.
- People with a known history of needing platelet transfusions due to chemotherapy, or who have experienced severe blood-related side effects (grade 3 or higher) from prior cancer treatment.
- People with a known history of myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML), which are types of blood or bone marrow disorders.
- People with a serious uncontrolled medical condition, a significant non-cancer illness, or an active uncontrolled infection.
- People who have been diagnosed with, or treated for, a different type of cancer within the 2 years before starting this study.
- People with brain or spinal fluid metastases that are not controlled.
- People who have had an allogeneic bone marrow transplant or double umbilical cord blood transplant.
- People who are unable to swallow oral medications.
- People with digestive system conditions that may affect how the body absorbs the study drugs.
- People who have had an active systemic autoimmune disease requiring treatment (such as immune-modifying drugs, steroids, or immunosuppressants) within the past 2 years.
- People with a history of HIV, or active hepatitis B or C.
- Women who are pregnant or currently breastfeeding, or fertile people who do not have an effective method of contraception.
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.
If this is close to home
This page includes language about advanced illness, prognosis, or palliative care, because that is how the trial's eligibility criteria are written. Seeing it set out plainly can land hard, whether it is about you or about someone you are caring for. You do not have to be at a crisis point to talk to someone.
- Griefline — grief and loss counselling, 9am to 6pm weekdays and midday to 6pm weekends (AEST/AEDT): 1300 845 745
- Carer Gateway — practical and emotional support if you are caring for someone, 8am to 5pm weekdays: 1800 422 737
- Canteen — for 12 to 25 year olds affected by cancer, their own or a family member's: 1800 945 215
- Palliative Care Australia — directory of palliative care services near you: palliativecare.org.au
- Lifeline — 24/7, for any kind of distress, at any hour the services above are closed: 13 11 14
Palliative care is not the same as giving up on treatment, and it is not only for the last weeks of life. It is symptom and comfort care that can run alongside active treatment, including a clinical trial.
Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of support and crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention.
Voxsanity is not a counselling or medical service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.
Contact this trial
Phone: 15824113524
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
This date has passed while the registry still lists the trial as open to participants. Sponsors often update a trial's status without revising its projected end date, so it may well still be recruiting — but the record is out of date in at least one respect. Check with the study contact before relying on either.
Where this trial is recruiting
Primary endpoints
Objective Response Rate (ORR)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 14 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.