Can a vaccine train the immune system to hunt down hidden breast cancer cells?

NCT ID NCT07721259

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jul 2030

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington, 98109, United States

    Contact Email: •••••@•••••

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