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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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,…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Immunogenicity
Timeframe: Up to 3 years
Trial details
NCT IDNCT03384914
SponsorH. Lee Moffitt Cancer Center and Research Institute