Status:
RECRUITING
Development of Patient Derived Xenografts (PDX) in Patients With Breast Cancer
Lead Sponsor:
Mayo Clinic
Conditions:
Breast Cancer
Residual
Eligibility:
All Genders
18+ years
Brief Summary
Breast cancer patients who undergo neoadjuvant systemic therapy and have residual breast cancer identified at the time of surgery exhibit a high (\>50%) risk of future life-threatening recurrences and...
Detailed Description
This study is being done to collect blood and leftover surgical tissue from patients with breast cancer remaining after chemotherapy or endocrine therapy is completed. We will use the blood and tissue...
Eligibility Criteria
Inclusion
- 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, ultrasound, 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
- 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).
Key Trial Info
Start Date :
January 13 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 15 2042
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04703244
Start Date
January 13 2021
End Date
January 15 2042
Last Update
April 29 2025
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905