Vaccine to Prevent Recurrence in Patients With HER-2 Positive Breast Cancer (NCT03384914) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Vaccine to Prevent Recurrence in Patients With HER-2 Positive Breast Cancer
United States119 participantsStarted 2018-02-19
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 (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,…
What they're measuring
1
Immunogenicity
Timeframe: Up to 3 years
Trial details
NCT IDNCT03384914
SponsorH. Lee Moffitt Cancer Center and Research Institute