A Study to Evaluate ctDNA Diagnostics in Recurrent Breast Cancer Patients
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 21-002803
Sponsor Protocol Number: 21-002803
About this study
The purpose of this study is to to establish a minimally-invasive blood based test for the detection of clinically actionable genetic changes in breast cancer patients.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Age 18 years or older.
- Histologic evidence of breast cancer with known hormone receptor and HER2 status.
- Initiation of new systemic therapy for recurrent or progressive metastatic disease or unresectable locally recurrent disease within four weeks of the blood draw.
- An understanding of the protocol and its requirements, risks, and discomforts.
- The ability and willingness to sign an informed consent.
Exclusion Criteria:
- Pregnancy or lactation (for females).
- Inability on the part of the patient to understand the informed consent or be compliant with the protocol.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Minetta Liu, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available