Breast Cancer FemalePhase 2NCT03384914
Vaccine to Prevent Recurrence in Patients With HER-2 Positive Breast Cancer
A Phase 2 study testing DC1 Vaccine and WOKVAC Vaccine in people with Breast Cancer Female and Breast Cancer, Male, run by H. Lee Moffitt Cancer Center and Research Institute at 7 sites in United States.
Trial summary
The main purpose of this study is to evaluate the safety of each study vaccine and to evaluate the effect on the time to disease recurrence (assessed by disease free survival). Participants will be assigned to receive one of two study vaccines (DC1 study vaccine vs. WOKVAC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer Female, Breast Cancer, Male, Breast Cancer Stage I
- What is being tested?
- DC1 Vaccine and WOKVAC Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 7 sitesUnited States
- Study dates
- 19 Feb 2018to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Emory - Winship Cancer Institute
Atlanta, Georgia, 30322
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263
Ohio State University - Arthur G James Cancer Hospital & Richard J Solove Research Institute
Columbus, Ohio, 43210
Indiana University - Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
University of Washington, Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
Official title: A Multicenter Phase II Study of Vaccines to Prevent Recurrence in Patients With HER-2 Positive Breast Cancer
The main purpose of this study is to evaluate the safety of each study vaccine and to evaluate the effect on the time to disease recurrence (assessed by disease free survival).
Participants will be assigned to receive one of two study vaccines (DC1 study vaccine vs. WOKVAC). The study vaccine will be administered in two phases: a study vaccination phase and a booster phase.
Read the detailed description
The total duration of the study will be 6 years (4 years of patient enrollment and 2 additional years of clinical follow-up). Assessment for disease recurrence and survival will be conducted every 6 months (with a phone call/secure email, medical records or follow up visit) from the end of treatment for a total of 2 years, until the completion of the trial or until documented disease recurrence.
- Conditions
- Breast Cancer Female, Breast Cancer, Male, Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III, Residual Disease
- Being tested
- DC1 Vaccine, WOKVAC Vaccine
- Keywords
- axillary nodes, HER-2 directed treatment
- Medical subject headings
- Breast Neoplasms, Male, Breast Neoplasms, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DC1 VaccineBiological
Also called Immunotherapy, Dendritic Cell Vaccine
Vaccination Phase: DC1 vaccine will be administered weekly via intranodal injection in weeks 1 to 6 (window 8-21days between vaccines).
Booster vaccines will be administered at approximately 3 month intervals on months 6, 9 and 12 (with a window +/- 1 month).
WOKVAC VaccineBiological
Also called Immunotherapy, pUMVC3-IGFBP2-HER2-IGF1R
Vaccination Phase: WOKVAC vaccine will be administered via intradermal injection on weeks 1, 4 and 7 (window +21 days).
Booster vaccines will be administered at approximately 3 month intervals on months 6, 9 and 12 (with a window +/- 1 month).
| Study group | Role | What they receive |
|---|---|---|
| Dendritic Cell (DC1) Vaccine | Active comparator | The vaccine will be administered in two phases: a vaccination phase and a booster phase.
Approximately 6 months from the initiation of the first vaccine, patients will receive the first of 3 booster vaccines. Receives: Biological: DC1 Vaccine |
| pUMVC3-IGFBP2-HER2-IGF1R (WOKVAC) | Active comparator | The vaccine will be administered in two phases: a vaccination phase and a booster phase.
Approximately 6 months from the initiation of the first vaccine, patients will receive the first of 3 booster vaccines. Receives: Biological: WOKVAC Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity
The primary immunogenicity outcome for both arms of this trial will be the summation of spots (ELISPOT) for 6 distinct peptides and reported as total SFC/10^6 cells. A value >150 defines an immune response.
Measured: Up to 3 years
Secondary outcomes (1)
Disease-free Survival (DFS)
Clinical activity is characterized by disease-free survival (DFS), defined as the time from start of treatment to documented recurrence (any breast event), death due to any cause or last patient contact that documents recurrence-free status (i.e., a clinic or scan date).
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2017
- Study start19 Feb 2018
- Primary completion22 Dec 2025
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Hyo S. Han, M.D., Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03384914
- Sponsor's protocol ID
- MCC-19117
- Status last verified
- Mar 2026
- First submitted
- 20 Dec 2017
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase II Study of Vaccines to Prevent Recurrence in Patients With HER-2 Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT03384914
- Acronym / sponsor ID
- MCC-19117
- Conditions
- Breast Cancer Female, Breast Cancer, Male, Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III, Residual Disease
- Keywords
- axillary nodes, HER-2 directed treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 119 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 19 Feb 2018 (actual)
- Primary completion
- 22 Dec 2025 (actual)
- Study completion
- Dec 2027 (estimated)
- First posted
- 28 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to evaluate the safety of each study vaccine and to evaluate the effect on the time to disease recurrence (assessed by disease free survival).
Participants will be assigned to receive one of two study vaccines (DC1 study vaccine vs. WOKVAC). The study vaccine will be administered in two phases: a study vaccination phase and a booster phase.
Detailed description
The total duration of the study will be 6 years (4 years of patient enrollment and 2 additional years of clinical follow-up). Assessment for disease recurrence and survival will be conducted every 6 months (with a phone call/secure email, medical records or follow up visit) from the end of treatment for a total of 2 years, until the completion of the trial or until documented disease recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dendritic Cell (DC1) Vaccine | Active comparator | Biological: DC1 VaccineThe vaccine will be administered in two phases: a vaccination phase and a booster phase. Approximately 6 months from the initiation of the first vaccine, patients will receive the first of 3 booster vaccines. |
| pUMVC3-IGFBP2-HER2-IGF1R (WOKVAC) | Active comparator | Biological: WOKVAC VaccineThe vaccine will be administered in two phases: a vaccination phase and a booster phase. Approximately 6 months from the initiation of the first vaccine, patients will receive the first of 3 booster vaccines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DC1 VaccineAlso: Immunotherapy, Dendritic Cell VaccineVaccination Phase: DC1 vaccine will be administered weekly via intranodal injection in weeks 1 to 6 (window 8-21days between vaccines). Booster vaccines will be administered at approximately 3 month intervals on months 6, 9 and 12 (with a window +/- 1 month). | Biological | Dendritic Cell (DC1) Vaccine |
| WOKVAC VaccineAlso: Immunotherapy, pUMVC3-IGFBP2-HER2-IGF1RVaccination Phase: WOKVAC vaccine will be administered via intradermal injection on weeks 1, 4 and 7 (window +21 days). Booster vaccines will be administered at approximately 3 month intervals on months 6, 9 and 12 (with a window +/- 1 month). | Biological | pUMVC3-IGFBP2-HER2-IGF1R (WOKVAC) |
Primary outcome
Immunogenicity
Time frame: Up to 3 years
The primary immunogenicity outcome for both arms of this trial will be the summation of spots (ELISPOT) for 6 distinct peptides and reported as total SFC/10^6 cells. A value >150 defines an immune response.
1 secondary outcome
Disease-free Survival (DFS)
Time frame: Up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Moffitt Cancer Center Clinical Trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyo S. Han, M.D. principal investigator
H. Lee Moffitt Cancer Center and Research Institute
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DC1 Vaccine and WOKVAC Vaccine in people with Breast Cancer Female and Breast Cancer, Male, run by H. Lee Moffitt Cancer Center and Research Institute at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunogenicity (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.