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

Running, not enrolling · Phase 2

Conditions studied: 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

In brief

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.

Key facts

Study ID: NCT03384914
Run by: H. Lee Moffitt Cancer Center and Research Institute
People needed: 119
Starts: 2018-02-19
Expected to finish: 2027-12-01
Last updated by the study team: 2026-03-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
Ability to understand and willingness to sign a written informed consent document prior to initiation of any screening or study-specific procedures.

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.

Where it is running

H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States
Emory - Winship Cancer Institute — Atlanta, Georgia, United States
Indiana University - Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States
Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
Roswell Park Comprehensive Cancer Center — Buffalo, New York, United States
Ohio State University - Arthur G James Cancer Hospital & Richard J Solove Research Institute — Columbus, Ohio, United States
University of Washington, Fred Hutchinson Cancer Research Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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