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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 230 participants in total. It began in 2020-07-31 with a primary completion date of 2028-07-27.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 use for primary prevention of nausea per institutional guidelines are allowed.
Contact & Investigator
Saranya Chumsri, MD
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT04517838 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04517838 currently recruiting?
Yes, NCT04517838 is actively recruiting participants. Contact the research team at mayocliniccancerstudies@mayo.edu for enrollment information.
Where is the NCT04517838 trial being conducted?
This trial is being conducted at Jacksonville, United States.
Who is sponsoring the NCT04517838 clinical trial?
NCT04517838 is sponsored by Mayo Clinic. The principal investigator is Saranya Chumsri, MD at Mayo Clinic. The trial plans to enroll 230 participants.