New vaccine combo aims to supercharge immune attack on aggressive breast cancer
NCT ID NCT05325632
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding a personalized dendritic cell vaccine to standard chemotherapy and targeted therapy can help people with HER2-positive breast cancer. About 53 participants will receive the vaccine alongside standard drugs before surgery. The main goal is to see if this combination leads to no cancer remaining at the time of surgery.
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 53 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2021
- Expected to finish
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Sep 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: * Participants must have histologically confirmed clinical stage I- III, HER2+ (per ASCO/CAP criteria) invasive carcinoma of the breast. Primary tumor should measure at least 1 cm by clinical exam or radiologic tests * Candidate for neoadjuvant chemotherapy with Paclitaxel, Trastuzumab, Pertuzumab regimen followed by standard of care local therapy as determined by the treating physician * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Participants must have normal organ and marrow function as defined per protocol. * Cardiac ejection fraction within institutional normal limits by either Multigated Acquisition Scan (MUGA) or Echocardiogram 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: * Participants 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. * Patients 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 (paclitaxel, trastuzumab, pertuzumab). * Participants who are 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. * Pregnant women and women who are breastfeeding. * Participants with known congenital or acquired immune deficiency (including those patients who require systemic immunosuppressant drugs for autoimmune disease or organ transplant).
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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 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
Locations
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Moffitt Cancer Center
RECRUITINGTampa, Florida, 33612, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Two-Drug HER2 attack vs one: which First-Line strategy helps advanced breast cancer patients live longer?
- Can a PI3K inhibitor boost presurgery breast cancer treatment?
- Can a platform trial match the right drug combo to each tumor?
- Can a shorter treatment hold off small HER2-Positive breast cancers?
- Can a Double-Pronged antibody outsmart HER2-Positive tumors?
- Can a vaccine teach the immune system to fight HER2-Positive tumors?