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



Status:Recruiting
Conditions:Breast Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/21/2019
Start Date:February 9, 2018
End Date:March 2023

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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.

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.

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)

- Less than 6 months from the completion of last trastuzumab maintenance infusion.

- Age ≥ 18 years.

- Eastern Cooperative Group (ECOG) performance status 0 or 1.

- Must have normal organ and marrow function as defined below within 2 weeks of
registration:

- 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.
We found this trial at
2
sites
12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
Principal Investigator: Hyo S. Han, M.D.
Phone: 813-745-5151
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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1959 Northeast Pacific Street
Seattle, Washington 98109
Principal Investigator: Mary (Nora) Disis, M.D.
Phone: 206-616-1823
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