Description:
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.
Title
- Brief Title: Vaccine to Prevent Recurrence in Patients With HER-2 Positive Breast Cancer
- Official Title: A Multicenter Phase II Study of Vaccines to Prevent Recurrence in Patients With HER-2 Positive Breast Cancer
Clinical Trial IDs
- ORG STUDY ID:
MCC-19117
- NCT ID:
NCT03384914
Conditions
- Breast Cancer Female
- Breast Cancer, Male
- Breast Cancer Stage I
- Breast Cancer Stage II
- Breast Cancer Stage III
- Residual Disease
- HER2-positive Breast Cancer
- HER2 Positive Breast Carcinoma
Interventions
Drug | Synonyms | Arms |
---|
DC1 Vaccine | Immunotherapy, Dendritic Cell Vaccine | Dendritic Cell (DC1) Vaccine |
WOKVAC Vaccine | Immunotherapy, pUMVC3-IGFBP2-HER2-IGF1R | pUMVC3-IGFBP2-HER2-IGF1R (WOKVAC) |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
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. | |
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. | |
Eligibility Criteria
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 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 adotrastuzumab
emtansine (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 within 30 days of start of
treatment:
- Absolute neutrophil count (ANC) ≥ 1,500/ 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 use of immunosuppressive agents or systemic corticosteroids. Topical, ocular,
intra-articular, intranasal, inhalational corticosteroids (with minimal systemic
absorption) are allowed. Patients who have received systemic corticosteroids ≤ 30days
prior to starting study drug will be excluded.
- Potential participant is currently enrolled in any other clinical protocol or
investigational trial that involves administration of experimental therapy and/or
therapeutic devices, or investigational drug.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Immunogenicity |
Time Frame: | Up to 7 years |
Safety Issue: | |
Description: | 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. |
Secondary Outcome Measures
Measure: | Disease-free Survival (DFS) |
Time Frame: | Up to 7 years |
Safety Issue: | |
Description: | 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). |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | H. Lee Moffitt Cancer Center and Research Institute |
Trial Keywords
- axillary nodes
- HER-2 directed treatment
Last Updated
August 3, 2021