Can vaccines keep breast cancer away? new study tests two options
NCT ID NCT03384914
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests two different vaccines designed to prevent HER-2 positive breast cancer from coming back in people who have already completed initial treatment. About 119 participants who had surgery after chemotherapy will receive one of the two vaccines, followed by booster shots. The main goals are to check the vaccines' safety and see if they can delay or stop the cancer from returning.
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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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119 people
The number who actually took part.
- Started
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Feb 2018
- Expected to finish
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Dec 2027
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: * Clinical stage I-III HER2 positive breast cancer treated with neoadjuvant chemotherapy including HER-2 directed treatment for at least 12 weeks. * Residual invasive carcinoma in the breast or axillary nodes in the final pathology from resected tumor following neoadjuvant chemotherapy. * Completed last cycle of cytotoxic chemotherapy (excluding ado-trastuzumab emtansine \[T-DM1\]) or radiation \> 30 days with resolution of all acute toxic effects of prior therapy to grade ≤ 2 (except alopecia) * Currently on HER-2 targeted therapy (eg; trastuzumab +/- pertuzumab or T-DM1) per standard of care or has completed HER-2 targeted therapy less than 6 months ago * Age ≥ 18 years. * Eastern Cooperative Group (ECOG) performance status 0 or 1. * Must have normal organ and marrow function as defined below: * Absolute neutrophil count (ANC) ≥ 1,000/ μL * Platelets ≥ 75,000/ μL * 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 * AST/ALT ≤ 3 x institutional upper limit of normal (ULN) * Creatinine ≤ 1.5 x institutional upper limit of normal (ULN) * Hemoglobin A1C \<6.5% * Left ventricular ejection fraction (LVEF) above institutional lower limit of normal (by echocardiogram or MUGA scan within 90 days of registration). * Females of child-bearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening, and males must use an effective barrier method of contraception if sexually active with a female of child-bearing potential. For both male and female participants, effective methods of contraception must be used throughout the study and for three months following the last dose. * Ability to understand and willingness to sign a written informed consent document prior to initiation of any screening or study-specific procedures. Exclusion Criteria: * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, congenital prolonged QT syndrome, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Uncontrolled autoimmune disease requiring active systemic treatment. * Known hypersensitivity reaction to the Granulocyte-macrophage colony stimulating factor (GM-CSF) adjuvant; any known contraindication to GM-CSF. * Pregnant or breast feeding. * Known HIV-positive. * Known current or a history of hepatitis B or C virus, including chronic and dormant states, unless disease has been treated and confirmed cleared. * Major surgery within 4 weeks of initiation of study drug. * Current extended use of immunosuppressive agents or systemic corticosteroids. Topical, ocular, intra-articular, intranasal, inhalational corticosteroids (with minimal systemic absorption) are allowed. A brief course of corticosteroids for prophylaxis (eg., for contrast dye allergy) or for treatment of non-autoimmune conditions (eg., delayed-type hypersensitivity reaction caused by a contact allergen) is permitted. * Potential participant is currently on active treatment in any other clinical protocol or investigational trial that involves administration of experimental therapy and/or therapeutic devices, or investigational drug.
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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
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Emory - Winship Cancer Institute
Atlanta, Georgia, 30322, United States
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H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612, United States
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Indiana University - Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
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Ohio State University - Arthur G James Cancer Hospital & Richard J Solove Research Institute
Columbus, Ohio, 43210, United States
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Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263, United States
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Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
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University of Washington, Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109, United States
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Other studies related to the condition(s) this trial covers.
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