A Study to Evaluate the Immune Response to Anti-HER2 Therapies
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 19-011040
NCT ID: NCT04517838
Sponsor Protocol Number: MC1937
About this study
The purpose of this study is to determine the correlation between HER2 specific T-cell response in HER2-positive breast cancer patients with stage I-IV who receive anti-HER2 therapies, such as trastuzumab, pertuzumab, lapatinib, or neratinib and clinical responses.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Age ≥ 18 years.
- Histological confirmed adenocarcinoma of the breast stage I-IV from the American Joint Committee on Cancer staging 8th edition.
- Any ER or PR but HER2 positive defined as 3+ staining intensity (on a scale of 0 to 3) by means of IHC analysis OR gene amplification on fluorescence in situ hybridization (FISH) ratio ≥ 2.0.
- Scheded to start new anti=HER2 therapy/therapies.
- Provide written informed consent.
- Willingness to provide blood samples for correlative research purposes.
Exclusion Criteria:
- Immunocompromised patients including patients known to be HIV positive.
- Receiving systemic steroid therapy or any other immunosuppressive therapy ≤ 30 days prior to registration. NOTE: Inhaled steroids, low-dose corticosteroids (e.g., equivalent to or less than oral prednisone 10 mg daily), and steroid use for primary prevention of nausea per institutional guidelines are allowed.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
Contact |
Jacksonville, Fla.
Mayo Clinic principal investigator Saranya Chumsri, M.D. |
Open for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
More information
Publications
Publications are currently not available