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

RecruitingObservational study

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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).

About the 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.

What is being tested

Sponsor: Mayo Clinic · Participants: 999 · Started: Jan 13, 2021

Contact the study team

Official record on ClinicalTrials.gov — NCT04703244

Locations in the U.S.

MinnesotaMayo Clinic, Rochester

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.