Can a vaccine train the immune system to hunt down hidden breast cancer cells?
NCT ID NCT07721259
First seen Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time
Summary
This phase II trial is testing whether a vaccine called STEMVAC can help prevent triple-negative breast cancer from coming back after surgery. The vaccine targets proteins that cancer cells use to grow and spread, aiming to boost the immune system to destroy any remaining tumor cells. The study enrolls patients who still have moderate or large amounts of cancer left after chemotherapy and surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a multi-antigen DNA vaccine called STEMVAC, given with a GM-CSF immune booster
- What this could lead to
- If it works, this could offer a new way to reduce the risk of breast cancer returning in patients with high-risk triple-negative breast cancer.
- What could go wrong
- This is an early phase II trial with only 60 participants, so results may not apply broadly. The vaccine may cause side effects or fail to improve survival.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * At least 18 years of age * Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2 * Triple-negative breast cancer as determined by the treating oncologist * Completed standard of care neoadjuvant chemotherapy in the opinion of their treating oncologist * Patients whose tumors progress on neoadjuvant therapy may be enrolled * No clinical evidence of local or distant recurrence * Plan to receive standard of care adjuvant directed therapy * Completed standard of care locoregional treatment, including definitive breast and lymph node surgery followed by standard radiation therapy, if recommended * Residual cancer burden (RCB) index 2 or 3 as calculated per routine anatomic pathology clinical standards * Absolute neutrophil count (ANC) ≥ 800/μL (within 30 days of first study vaccine administration) * Hemoglobin (Hgb) ≥ 8 g/dL (within 30 days of first study vaccine administration) * Platelets ≥ 75,000/ μL (within 30 days of first study vaccine administration) * Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN), except patients with Gilbert's syndrome, in whom total bilirubin must be \< 3.0 mg/dL (within 30 days of first study vaccine administration) * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 1.5 x institutional ULN (within 30 days of first study vaccine administration) * Creatinine ≤ 1.5 x ULN mg/dL or creatinine clearance \> 60 mL/min (within 30 days of first study vaccine administration) * At least 28 days post systemic steroids prior to enrollment, unless used as part of prophylaxis to prevent intravenous (IV) contrast reactions. * Topical, ocular, intra-articular, intranasal, inhalational corticosteroids (with minimal systemic absorption) are allowed * Must have recovered from major infections and/or surgical procedures; and in the opinion of the investigator, not have any significant active concurrent medical illnesses or condition precluding protocol treatment * Patients of child-bearing potential must agree to use dual methods of contraception and have a negative urine pregnancy test at screening, and male patients must use an effective barrier method of contraception if sexually active with a person of child-bearing potential. Acceptable methods of contraception are abstinence, condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal Exclusion Criteria: * Toxicities related to prior exposure to immune checkpoint inhibitors for which immune checkpoint inhibitors cannot be safely continued as determined by study investigator * Germline BRCA1 or BRCA2 mutations with adjuvant olaparib planned within the study period * NOTE: If olaparib is not planned, then these patients are eligible * Any known cardiac conditions: * Symptomatic restrictive cardiomyopathy * Dilated cardiomyopathy * Unstable angina within 4 months prior to enrollment * New York Heart Association functional class III-IV heart failure on active treatment * Symptomatic pericardial effusion * Autoimmune disease requiring active systemic treatment * Known hypersensitivity reaction to the GM-CSF adjuvant; any known contra-indication to GM-CSF * Pregnant or breast feeding * Known history of human immunodeficiency virus (HIV) infection, hepatitis B (e.g., hepatitis B virus surface antigen \[HBsAg\] reactive), or hepatitis C (e.g., hepatitis C virus \[HCV\] ribonucleic acid \[RNA\] is detected) * Major surgery within the 4 weeks prior to initiation of first study vaccine * Enrollment in any other clinical protocol or investigational trial that involves concurrent administration of experimental therapy and/or therapeutic devices, or investigational drug. Patients who completed prior clinical trials (such as neoadjuvant treatment, surgery or radiation trials) and are on long term follow up are permitted
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
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Study contacts
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Contact
Email: •••••@•••••
Locations
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Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109, United States
Contact Email: •••••@•••••
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