RecruitingNCT04703244

Development of Patient Derived Xenografts (PDX) in Patients With Breast Cancer

Development of Patient Derived Xenografts (PDX) in Patients With Breast Cancer Who Have Residual Disease After Neoadjuvant Systemic Therapy

Sponsor

Mayo Clinic

Enrollment

999 participants

Start Date

Jan 13, 2021

Study Type

OBSERVATIONAL

Conditions

Breast Cancer Residual

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 death.

Eligibility

Min Age: 18 Years

Inclusion Criteria12

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 Criteria2

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).