Vaccine to Prevent Recurrence in Patients With HER-2 Positive Breast Cancer

NCT03384914 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: MCC-19117
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 7

Brief 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). The study vaccine will be administered in two phases: a study vaccination phase and a booster phase.

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

Keywords

axillary nodes; HER-2 directed treatment

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 3 years

Secondary Outcomes (1)

• Disease-free Survival (DFS)

  Up to 3 years

Study Arms (2)

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.

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.

Biological: WOKVAC Vaccine

Interventions

DC1 Vaccine BIOLOGICAL

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).

Also known as: Immunotherapy, Dendritic Cell Vaccine

Dendritic Cell (DC1) Vaccine

WOKVAC Vaccine BIOLOGICAL

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).

Also known as: Immunotherapy, pUMVC3-IGFBP2-HER2-IGF1R

pUMVC3-IGFBP2-HER2-IGF1R (WOKVAC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• United States Department of Defense: collaborator

Study Sites (7)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Emory - Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Indiana University - Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263, United States

Location

Ohio State University - Arthur G James Cancer Hospital & Richard J Solove Research Institute

Columbus, Ohio, 43210, United States

Location

University of Washington, Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Related Links

• Moffitt Cancer Center Clinical Trials website

MeSH Terms

Conditions

Breast Neoplasms, Male; Breast Neoplasms; Neoplasm, Residual

Interventions

Immunotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics

Study Officials

• Hyo S. Han, M.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2017
• First Posted: December 28, 2017
• Study Start: February 19, 2018
• Primary Completion: December 22, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 6, 2026

Record last verified: 2026-03

Locations

US (7)