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

NCT04517838 | Recruiting

• 3 other identifiers: MC1937NCI-2020-0578119-011040
• Study Type: observational
• Target: 230
• Locations: 1 country
• Sites: 1

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 IV Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8

Outcome Measures

Primary Outcomes (2)

• HER2 specific T-cell response and clinical response

  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.

  Up to 16 weeks

• Antibody response and clinical response

  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.

  Up to 16 weeks

Other Outcomes (9)

• Proportion of patients who develop HER2-specific T cell and endogenous antibody responses

  Up to 16 weeks

• Levels of HER2 CD4 T-cells, HER2 CD8 T-cells, and HER2-specific antibodies

  Up to 16 weeks

• Association between combination therapy and immunity to common breast cancer associated antigens

  Up to 16 weeks

Study Arms (2)

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.

Procedure: Biospecimen Collection

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.

Procedure: Biospecimen Collection

Interventions

Biospecimen Collection PROCEDURE

Undergo collection of blood and tumor tissue samples

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Observational Blood & Tissue Cohort; Observational Tissue-Only Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Stage I-IV HER2 positive breast cancer patients

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITH DNA

Blood, tissue

MeSH Terms

Interventions

Specimen Handling

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Saranya Chumsri, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2020
• First Posted: August 18, 2020
• Study Start: July 31, 2020
• Primary Completion (Estimated): July 27, 2028
• Study Completion (Estimated): July 27, 2028
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

US (1)