A Study to Evaluate the Development of Patient Derived Xenografts in Patients With Breast Cancer
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: 19-009192
NCT ID: NCT04703244
Sponsor Protocol Number: MC1933
About this study
Collection of tissue and blood from patients with residual disease after neoadjuvant systemic therapy for breast cancer. We hope to use these samples to find out why some patients still have cancer after they have completed neoadjuvant anticancer therapy.
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.
- Diagnosis of invasive breast cancer treated with neoadjuvant systemic therapy.
- Surgically resectable disease following neoadjuvant systemic treatment.
- At least one of the following must be true:
- Received at least 2 weeks of neoadjuvant endocrine therapy;
- Received at least 2 months of neoadjuvant chemotherapy with suggestion of residual disease on imaging;
- Began neoadjuvant chemotherapy or endocrine therapy but discontinued due to evidence of progressive disease by MRI, US, or physical examination.
- Provide written informed consent.
- Willing to return to enrolling institution for breast cancer surgery.
- Willingness to provide mandatory blood specimens for future research on breast cancer at Mayo Clinic.
- Willingness to provide mandatory tissue specimens for future research on breast cancer at Mayo Clinic.
- Willingness to provide mandatory tissue specimens for the generation of PDX and organoids to be used future research on breast cancer at Mayo Clinic.
Exclusion Criteria:
- Ineligible for surgery.
- History of prior malignancy < 3 years prior to registration.
- Exceptions for non-melanoma skin cancer, papillary thyroid cancer, non-invasive cancer (e.g., carcinoma in situ of the cervix).
Eligibility last updated 7/25/23. Questions regarding updates should be directed to the study team contact.
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 |
Contact |
Rochester, Minn.
Mayo Clinic principal investigator Judy Boughey, M.D. |
Open for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
855-776-0015
|
More information
Publications
Publications are currently not available