Recruiting
Development of Patient Derived Xenografts (PDX) in Patients With Breast Cancer
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.
ClinicalTrials.gov IDNCT04703244
PhaseNot Applicable
Enrollment999
SponsorMayo Clinic
Age18 Years
SexALL
Conditions studied
Breast Cancer, Residual
About this study
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.
Interventions
- Procedure: chemotherapy or endocrine therapy for breast cancer — Collect blood and leftover surgical tissue from patients with breast cancer remaining after chemotherapy or endocrine therapy is completed.
Primary outcomes
- Generate patient derived xenografts (PDX) and organoids from breast cancer patients with residual disease after neoadjuvant therapy (Up to 12 months until death or a maximum of 20 years post registration)
Eligibility information
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, 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 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).
Study locations
- Mayo Clinic, Rochester, Minnesota 55905 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.