Recruiting

Anti-HER2 Therapies

Sponsor:

Mayo Clinic

Code:

NCT04517838

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

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Study Details

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.

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

Study ID

NCT04517838

Start date

Jul 31, 2020

Status verified date

Jun, 2026

Completion date

Jul 27, 2028

Anticipated

Primary completion date

Jul 27, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

230 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational Blood & Tissue Cohort

Patients with stage I-III disease undergo collection of blood samples at baseline, 8 and 16 weeks after starting treatment, and at the time of invasive disease recurrence. Patients with stage IV disease undergo collection of blood samples at baseline, 8 and 16 weeks after starting treatment, and at the time of progressive disease. Patients with stage IV disease with no disease progression ≥ 2 years on the same line of therapy undergo collection of blood samples at baseline, 8 and 16 weeks after starting treatment, and at the time of invasive disease recurrence. For all patients, tissue samples from previous biopsy and/or surgical resection are also collected on study.

Observational Tissue-Only Cohort

For patients with stage I-IV disease who received or previously completed anti-HER2 therapy, tissue samples from previous biopsy and/or surgical resection are collected on study.

Interventions

Biospecimen Collection

Undergo collection of blood and tumor tissue samples

Primary outcome measure

  • HER2 specific T-cell response and clinical response [ Time Frame: Up to 16 weeks ]
  • Antibody response and clinical response [ Time Frame: Up to 16 weeks ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Florida

Recruiting

Jacksonville, Florida, United States, 32224-9980

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Saranya Chumsri, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Jun 16, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-06-16.