Printed from Voxsanity (voxsanity.com.au) — NCT07721259 — 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
NCT07721259
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 are at least 18 years old
- People whose ability to carry out daily activities is reasonably well maintained, as measured by a standard oncology scoring system (a score of 2 or lower on the ECOG scale)
- People who have been diagnosed with triple-negative breast cancer by their treating cancer doctor
- People who have finished the standard pre-surgery chemotherapy (chemotherapy given before surgery), in the opinion of their treating cancer doctor
- People whose cancer continued to grow or spread during pre-surgery chemotherapy may still be considered
- People who have no signs that the cancer has come back locally or spread to other parts of the body
- People who are planned to receive the standard follow-up (adjuvant) treatment after surgery
- People who have completed the standard local treatments, including surgery on the breast and lymph nodes, and radiation therapy if it was recommended
- People who have a moderate or high amount of cancer remaining after pre-surgery treatment, as measured by a standard pathology scoring system (Residual Cancer Burden index of 2 or 3)
- People whose blood test results within 30 days before the first study vaccine show a sufficient level of infection-fighting white blood cells (neutrophils at 800/μL or above)
- People whose blood test results within 30 days before the first study vaccine show a sufficient haemoglobin level (8 g/dL or above)
- People whose blood test results within 30 days before the first study vaccine show a sufficient platelet count (75,000/μL or above)
- People whose liver function blood test results within 30 days before the first study vaccine are within an acceptable range for bilirubin (with a specific, slightly higher limit allowed for people with a condition called Gilbert's syndrome)
- People whose liver enzyme blood test results (AST and ALT) within 30 days before the first study vaccine are within an acceptable range
- People whose kidney function test results within 30 days before the first study vaccine show the kidneys are working adequately
- People who have not taken systemic (whole-body) steroid medications for at least 28 days before joining, unless the steroids were used to prevent a reaction to an intravenous contrast dye
- People who are using steroid treatments that stay mostly local and are not absorbed throughout the body — such as skin creams, eye drops, joint injections, nasal sprays, or inhalers — are still able to be considered
- People who have recovered from any major infections or surgeries and, in the view of the study doctor, do not have any significant active health conditions that would prevent participation
- People of childbearing potential who agree to use two forms of contraception at the same time and have a negative urine pregnancy test at screening; male participants who are sexually active with a person of childbearing potential must use an effective barrier method of contraception (acceptable methods include abstinence, condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or having a partner who is surgically sterilised or post-menopausal)
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 had side effects from previous immune checkpoint inhibitor treatment that mean those medicines cannot be safely continued, as determined by the study doctor
- People who carry an inherited BRCA1 or BRCA2 gene mutation and who are planned to take a medicine called olaparib during the study period (people with these mutations who are not planned to take olaparib may still be considered)
- People who have any of the following heart conditions: a stiffening of the heart muscle that causes symptoms, an enlarged and weakened heart, unstable chest pain (angina) within the 4 months before joining, moderate-to-severe heart failure that is actively being treated, or a fluid build-up around the heart that is causing symptoms
- People who have an autoimmune disease that currently requires active treatment affecting the whole body
- People who have a known allergic reaction to the GM-CSF adjuvant (a substance used alongside the vaccine), or any other known reason they cannot receive GM-CSF
- People who are pregnant or breastfeeding
- People with a known history of HIV infection, active hepatitis B, or active hepatitis C
- People who have had major surgery within the 4 weeks before the first study vaccine is due to be given
- People who are currently enrolled in another clinical trial that involves receiving an experimental treatment or investigational device at the same time (people who completed a previous clinical trial and are only attending long-term follow-up appointments are still able to be considered)
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
Principal Investigator: Natasha Hunter, MD, Fred Hutch/University of Washington Cancer Consortium
Phone: 866-932-8588
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
Registry
ClinicalTrials.gov
Start date
30 September 2026
Est. completion
16 July 2029
Where this trial is recruiting
🇺🇸 United States
Primary endpoints
Invasive breast cancer free survival (IBCFS); Dynamics and characteristics of circulating tumor deoxyribonucleic acid (ctDNA)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 30 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.