Status:
RECRUITING
Immune Response to Anti-HER2 Therapies in Patients With HER2-Positive Stage I-IV Breast Cancer
Lead Sponsor:
Mayo Clinic
Conditions:
Breast Adenocarcinoma
HER2-Positive Breast Carcinoma
Eligibility:
FEMALE
18+ years
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...
Detailed Description
PRIMARY OBJECTIVES I. 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, p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 31 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 27 2028
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT04517838
Start Date
July 31 2020
End Date
July 27 2028
Last Update
December 24 2025
Active Locations (1)
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1
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980