Immune Response to Anti-HER2 Therapies in Patients With HER2-Positive Stage I-IV Breast Cancer (NCT04517838) | Clinical Trial Compass
RecruitingNot Applicable
Immune Response to Anti-HER2 Therapies in Patients With HER2-Positive Stage I-IV Breast Cancer
United States230 participantsStarted 2020-07-31
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is studying how my immune system responds to anti-HER2 therapies rather than testing a new treatment — does that mean I would still receive my standard HER2-targeted treatment, and what additional testing or blood draws would be involved on top of my normal care?
2Since this study is measuring HER2-specific T-cell and antibody responses, what would actually be done with that data, and could anything learned from my immune response change or influence my own treatment decisions during the study?
3The trial enrolls patients across stages I through IV, which covers very different situations — given my specific stage and treatment plan, would my doctor feel this study is a reasonable fit for where I am in my care right now?
4Because this is listed as Phase NA, which suggests it's more of an observational or correlative study than a traditional drug trial, how does that affect what risks or burdens I might face compared to a standard interventional clinical trial?
5Are there any circumstances where participating in this immune-response study could delay the start of my standard anti-HER2 therapy, and if I'm already mid-treatment, is it still possible to enroll?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
HER2 specific T-cell response and clinical response