Custom vaccine shows promise in targeting aggressive breast cancer
NCT ID NCT03387553
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tested a vaccine made from patients' own immune cells to target HER2-positive breast cancer. 31 participants with stage II or III breast cancer received the vaccine alongside standard chemotherapy before surgery. The goal was to see if the vaccine could boost the immune system's attack on cancer cells and improve treatment response.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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31 people
The number who actually took part.
- Started
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Jun 2018
- Finished
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Feb 2026
- 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: * Participants must have histologically confirmed clinical stage II or III ERPR- HER2+ (per CAP criteria) invasive carcinoma of the breast * Medically and surgically appropriate to undergo neoadjuvant chemotherapy with TCH-P Taxotere (docetaxel), Carboplatin, Herceptin (trastuzumab), Perjeta (pertuzumab) regimen followed by standard of care local therapy as determined by their treating physician * Age ≥18 years. * Eastern Cooperative Oncology Group (ECOG) performance status less than 2 * Patients must have normal organ and marrow function as defined below: * leukocytes ≥3,000/μL * absolute neutrophil count ≥1,500/μL * platelets ≥100,000/μL * total bilirubin within normal institutional limits * AST(SGOT)/ALT(SGPT) less than or equal to 2.5 X institutional upper limit of normal * creatinine within normal institutional limits - OR - * creatinine clearance ≥60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal * Cardiac ejection fraction within institutional normal limits by either MUGA or ECHO at baseline. * Women of child-bearing potential and their male partners must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Sexually active male participants should use a barrier method or exercise abstinence during chemotherapy administration until surgery. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Patients with inflammatory breast cancer, widespread locally advanced unresectable disease involving the chest wall/nodal basins in which a curative surgical resection cannot be performed, or those in whom de novo metastatic disease is suspected or confirmed * May not be receiving any other investigational agents for the treatment of their breast cancer. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study vaccine components and any of the chemotherapy drugs (docetaxel, carboplatin, trastuzumab, pertuzumab) * Unwilling or unable to undergo an apheresis for production of their vaccine * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Women who are pregnant or breastfeeding * Known congenital or acquired immune deficiency (including those patients who require systemic immunosuppressant drugs for autoimmune disease or organ transplant). * Pre-existing peripheral neuropathy that would limit treatment with taxanes and platinum agents
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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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H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612, United States
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Other studies related to the condition(s) this trial covers.
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