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Immune Response to Anti-HER2 Therapies in Patients With HER2-Positive Stage I-IV Breast Cancer

Recruitingn/aAges 18 Years - anyFemaleMayo Clinic
NCT04517838 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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 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 Criteria: * 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.
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What it tests

  • Biospecimen Collection
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Where

1 site
Mayo Clinic in Florida
Jacksonville, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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