Understanding immune responses in HER2-positive breast cancer treatment
Immune Response to Anti-HER2 Therapies
This study is trying to see how the immune system reacts to anti-HER2 treatments in patients with HER2-positive breast cancer and how these reactions might affect their treatment outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 230 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | prednisone, trastuzumab, pertuzumab, lapatinib, neratinib |
| Locations | 1 site (Jacksonville, Florida) |
| Trial ID | NCT04517838 on ClinicalTrials.gov |
What this trial studies
This observational study collects blood and tumor tissue samples from patients with HER2-positive breast cancer who are starting anti-HER2 therapies like trastuzumab and pertuzumab. The primary goal is to analyze the correlation between immune responses, including T-cell and antibody responses, and clinical outcomes in these patients. Additionally, the study aims to explore trends in immune responses over the course of treatment and their association with survival rates. By gathering this information, researchers hope to gain insights into how the immune system interacts with these therapies.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed HER2-positive breast adenocarcinoma at any stage (I-IV) who are scheduled to start anti-HER2 therapy.
Not a fit: Patients who are immunocompromised or receiving immunosuppressive therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with HER2-positive breast cancer by enhancing our understanding of immune responses.
How similar studies have performed: Other studies have shown promising results in understanding immune responses to cancer therapies, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Jacksonville, Florida
- Mayo Clinic in Florida — Jacksonville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Saranya Chumsri, MD — Mayo Clinic
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.