HER2 Vaccine for Locally Advanced Breast Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorPravin T.P Kaumaya
About this trial
The goal of this study is to test an investigational vaccine to activate the immune system to fight breast cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥ 18 years old at the time of informed consent
Ability to provide written informed consent and HIPAA authorization CTO-IUSCC-0864
Histologically confirmed HER2 positive breast cancer
Any Estrogen Receptor/Progesterone Receptor status is allowed.
Disqualifiers
Any distant disease recurrence.
Patients with active malignancy other than breast cancer. Note: Patients with prior malignancies without recurrence after standard treatment will not be excluded.
Patients receiving or planned to receive adjuvant CDK4/6 inhibitor therapy
Patients who are {MVF-HER-2(266-296) and MVF-HER-2 (597-626)} immediate hypersensitivity skin test positive.
Trial design
Design model
Single group
Treatments tested in this trial
HER2 Vaccine
DrugMVF-HER2 266-296 and MVF HER2 597-626 peptide vaccines
Treatment groups
36 Participants
are divided into 1 treatment groupGroup A: HER2 Vaccine ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Evaluation of safety and toxicity at regular intervals by NCI common toxicity criteria 5.0
Number of adverse events as assessed by the NCI CTCAE v. 5.0
Time frame
through completion of 3 vaccine series (i.e. up to day 64 post final vaccine injection)2
Immune Response
Humoral immune response will be measured by ELISA quantification of IgM and IgG antibodies to HER2 (597-626) and HER2 (266-296).
Time frame
through completion of 3 vaccine series (i.e. up to day 64 post final vaccine injection)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Pravin T.P Kaumaya
Lead sponsor
Indiana University
Sponsor institution
Source ClinicalTrials.gov