Actively Recruiting

Age: 18Years +
FEMALE
NCT04517838

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

Led by Mayo Clinic · Updated on 2025-12-24

230

Participants Needed

1

Research Sites

416 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age �3E= 18 years
  • Confirmed diagnosis of breast adenocarcinoma stage I-IV according to the American Joint Committee on Cancer staging 8th edition
  • HER2 positive status as defined by current American Society of Clinical Oncology/College of American Pathologists guidelines
  • Any estrogen receptor (ER) or progesterone receptor (PR) status
  • Able and willing to provide written informed consent
  • Willing to provide blood samples for research
  • For Blood and Tissue Cohort: Scheduled to start new anti-HER2 therapy
  • For Tissue-Only Cohort: Have received or completed anti-HER2 therapy
Not Eligible

You will not qualify if you...

  • Immunocompromised patients, including those known to have HIV
  • Receiving systemic steroid or other immunosuppressive therapy within 30 days before registration (except inhaled steroids, low-dose corticosteroids equivalent to prednisone 10 mg daily or less, and steroids for nausea prevention)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Mayo Clinic in Florida

Jacksonville, Florida, United States, 32224-9980

Actively Recruiting

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Research Team

C

Clinical Trials Referral Office

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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