What this study is
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.
What's being tested
- Biospecimen Collection
Intervention · PROCEDURE
Undergo collection of blood and tumor tissue samples
Study details
- Official title
- Immune Response to Anti-HER2 Therapies
- Sponsor
- Mayo Clinic
- 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 · Anatomic Stage IV Breast Cancer AJCC v8
- Enrolling
- 230 people
- Starts
- 2020-07-31
- Est. completion
- 2028-07-27
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex FEMALEHealthy volunteers Not acceptedYou 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 can't join 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 registrationExcept: 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openMayo Clinic in Florida
Jacksonville, Florida, United States
- Clinical Trials Referral Office · Contact855-776-0015mayocliniccancerstudies@mayo.edu
- Saranya Chumsri, MD · Principal investigator
Recruiting
Study team
Sponsor
Mayo Clinic
Study ID MC1937
Principal investigator
Saranya Chumsri, MD
Mayo Clinic
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.