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Observational Study of Immune Response to Anti-HER2 Therapies in Breast Cancer

This observational study is looking at how your body's immune system responds to common anti-HER2 therapies like trastuzumab, pertuzumab, lapatinib, or neratinib. It's for women aged 18 and older who have HER2-positive breast cancer (stages I-IV) and are about to start one of these treatments. Researchers will collect blood and tumor tissue samples to see if there's a link between your immune response (specifically, certain T-cells and antibodies) and how well you respond to the treatment. The goal is to better understand how these therapies work with your immune system. This study is currently unclear on its recruitment status and plans to enroll 230 participants.

Study design
This is an observational study, meaning researchers will collect information without giving you a new treatment. It aims to enroll 230 women.
What's involved
You would provide blood and tumor tissue samples during your treatment with anti-HER2 therapies.
Compensation
Not stated in the trial record.
Follow-up
Your immune and clinical responses will be measured for up to 16 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04517838

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

Recruiting
Not specifiedAges 18+Observational
Mayo Clinic
~230 participants
Updated 2026-06-16 on ClinicalTrials.gov
What's tested:Biospecimen Collection

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
HER2 specific T-cell response and clinical response
Measured over Up to 16 weeks
+1 more outcome measured

Conditions

Breast Adenocarcinoma
HER2-Positive Breast Carcinoma
Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
Anatomic Stage IV Breast Cancer AJCC v8

Explore related trials

Breast Carcinoma

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Saranya Chumsri, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

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Do you actually qualify for this trial?

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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.

What this trial measures

  • HER2 specific T-cell response and clinical responseUp to 16 weeks

    Defined as (1) a 2-fold or greater increase in HER2-specific T cells or HER2-specific antibodies at any point during treatment if pre-treatment levels of HER2-specific T cells or antibodies are detectable, or (2) HER2-specific T cells or HER2-specific antibodies at any point during treatment if pretreatment levels of HER-2 binding activity are non-detectable.

  • Antibody response and clinical responseUp to 16 weeks

    Defined as (1) a 2-fold or greater increase in HER2-specific T cells or HER2-specific antibodies at any point during treatment if pre-treatment levels of HER2-specific T cells or antibodies are detectable, or (2) HER2-specific T cells or HER2-specific antibodies at any point during treatment if pretreatment levels of HER-2 binding activity are non-detectable.