NCT04517838Recruiting
Immune Response to Anti-HER2 Therapies in Patients With HER2-Positive Stage I-IV Breast Cancer
Immune Response to Anti-HER2 Therapies
Source: ClinicalTrials.gov · Last updated 16 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 230 (estimated)
- First submitted
- 14 Aug 2020
- Start date
- 31 Jul 2020
- Primary completion date
- 27 Jul 2028
- Lead sponsor
- Mayo Clinic
- Diseases
- Metastatic breast cancer
- NCT number
- NCT04517838
What you commit to
- Study type: Observational
- Planned participants: 230
- From 31 Jul 2020 to the primary completion date, 27 Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Immunocompromised patients including patients known to be human immunodeficiency virus (HIV) positive
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Clinic in Florida Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.