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

Launched by MAYO CLINIC · Aug 14, 2020

Keywords

ClinConnect Summary

This clinical trial is studying how the body’s immune system responds to specific treatments for breast cancer that is HER2-positive, which means the cancer cells have a certain protein that can promote tumor growth. The researchers are collecting blood and tissue samples from women who have been diagnosed with HER2-positive breast cancer at any stage (I to IV) and are about to begin treatment with drugs like trastuzumab, pertuzumab, lapatinib, or neratinib. The goal is to better understand how these therapies interact with the immune system, which may help improve future treatments.

To participate, women must be at least 18 years old and have confirmed breast cancer that is HER2-positive, regardless of other hormone receptor statuses. Participants will need to provide written consent and agree to donate blood samples for research. Those who take part in the study can expect to contribute to valuable research that may help other patients in the future. However, individuals who have certain health conditions, like being immunocompromised or receiving specific immunosuppressive treatments, will not be eligible to join.

Gender

FEMALE

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.