RecruitingNCT04517838
Immune Response to Anti-HER2 Therapies in Patients With HER2-Positive Stage I-IV Breast Cancer
Immune Response to Anti-HER2 Therapies
Sponsor
Mayo Clinic
Enrollment
230 participants
Start Date
Jul 31, 2020
Study Type
OBSERVATIONAL
Conditions
Summary
This study gathers information from the blood cells and tumor tissue during treatment with anti-HER2 therapies, such as trastuzumab, pertuzumab, lapatinib, or neratinib, in patients with HER2 positive stage I-IV breast cancer who are scheduled to start anti-HER2 therapy. The information gained from this study may help researchers better understand the relation between cell response and anti-HER2 therapies.
Eligibility
Sex: FEMALEMin Age: 18 Years
Inclusion Criteria7
- Age \>= 18 years
- Histological confirmed adenocarcinoma of the breast stage I-IV from the American Joint Committee on Cancer staging 8th edition
- Any estrogen receptor (ER) or progesterone receptor (PR) but HER2 positive defined as per the most current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guideline
- Provide written informed consent
- Willingness to provide blood samples for correlative research purposes
- BLOOD AND TISSUE COHORT: Scheduled to start new anti-HER2 therapy/therapies
- TISSUE-ONLY COHORT: Received or previously completed anti-HER2 therapy/therapies
Exclusion Criteria2
- Immunocompromised patients including patients known to be human immunodeficiency virus (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.
Interventions
PROCEDUREBiospecimen Collection
Undergo collection of blood and tumor tissue samples
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04517838
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