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New vaccine aims to train immune system against breast cancer stem cells

NCT ID NCT02157051

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial tests a DNA vaccine called STEMVAC in 42 people with advanced HER2-negative breast cancer whose disease is stable or gone after standard treatment. The vaccine is designed to help the immune system recognize and attack cancer stem cells, which are often resistant to chemotherapy. The main goals are to check safety and see if the vaccine boosts the body's immune response against the cancer.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

42 people

The number who actually took part.

Started

Jun 2015

Expected to finish

Sep 2026

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: * Patients with stage III-IV HER2 negative breast cancer treated with primary or salvage therapy and now have: * No evidence of disease (NED), or * Stable bone only disease * Patients who have completed standard of care and recovered with mild to no residual toxicity from recent therapy * Patients must be at least 28 days post cytotoxic chemotherapy, and/or monoclonal antibody therapy (excluding bone-directed therapy), prior to enrollment * Patients must be at least 28 days post systemic steroids prior to enrollment * Patients on bisphosphonates, denosumab, and/or endocrine therapy are eligible * Patients must have Eastern Cooperative Oncology Group (ECOG) performance status score of =\< 1 * Patients 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 precluding protocol treatment * Estimated life expectancy of more than 6 months * White blood cells (WBC) \>= 3000/mm\^3 (within 30 days of first vaccination) * Lymphocyte count \>= 800/mm\^3 (within 30 days of first vaccination) * Platelet count \>= 75,000/mm\^3 (within 30 days of first vaccination) * Hemoglobin (Hgb) \>= 10 g/dl (within 30 days of first vaccination) * Serum creatinine \<= 1.2 mg/dl or creatinine clearance \> 60 ml/min (within 30 days of first vaccination) * Total bilirubin \<= 1.5 mg/dl (within 30 days of first vaccination) * Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) \<= 2 times upper limit of normal (ULN) (within 30 days of first vaccination) * Blood glucose \< 1.5 ULN (within 30 days of first vaccination) * All patients who are having sex that can lead to pregnancy must agree to contraception for the duration of study Exclusion Criteria: * Patients with any of the following cardiac conditions: * Symptomatic restrictive 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 * Patients at risk for gastrointestinal bleeding (example: peptic ulcer disease, prolonged daily non-steroidal anti-inflammatory use) * Patients with any seizure disorder * Patients with any contraindication to receiving rhuGM-CSF based products * Patients with any clinically significant autoimmune disease uncontrolled with treatment * Patients who are simultaneously enrolled in any other treatment study * Patients who are pregnant or breastfeeding

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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.

Contacts and locations

Locations

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington, 98109, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.