NCT04517838 Immune Response to Anti-HER2 Therapies in Patients With HER2-Positive Stage I-IV Breast Cancer
| NCT ID | NCT04517838 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mayo Clinic |
| Condition | Breast Adenocarcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 230 participants |
| Start Date | 2020-07-31 |
| Primary Completion | 2028-07-27 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief 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 Criteria
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 u