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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Residual
• Intervention / Treatment: Procedure: chemotherapy or endocrine therapy for breast cancer

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 for future studies. These studies will try to find ways to treat future breast cancer patients.

Because there is cancer left in your body after breast cancer treatment is finished, we think the cancer may be different than other cancers. Tissue from surgery will be used to try to grow that kind of cancer in the lab so we can find out more about it and how to treat it.

Blood samples will be used to look at measurements of biomarkers to see how this cancer is different and seek new ways to identify and treat it.

• Study Type: Observational
• Enrollment (Estimated): 999

Contacts and Locations

• Study Contact: Name: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic
      • Principal Investigator: Judy C. Boughey, M.D.
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
      • Principal Investigator: Matthew P. Goetz, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients who have completed neoadjuvant systemic therapy who have residual disease on post-neoadjuvant imaging and are planning surgical resection

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Utilize patient derived xenografts (PDX) models to study new drugs/drug combinations	Up to 12 months until death or a maximum of 20 years post registration
Utilize patient derived xenografts (PDX) models to identify mechanisms of treatment resistance	Up to 12 months until death or a maximum of 20 years post registration
Correlate the association between Cell Free DNA (cfDNA), Circulating Tumor Cells (CTCs) and circulating immune cell subpopulations (as measured by CyTOF) with residual cancer burden	Up to 12 months until death or a maximum of 20 years post registration
Correlate the association between Cell Free DNA (cfDNA) with residual cancer burden	Up to 12 months until death or a maximum of 20 years post registration
Correlate the association between Circulating Tumor Cells (CTCs) with residual cancer burden	Up to 12 months until death or a maximum of 20 years post registration
Correlate the association between circulating immune cell subpopulations (as measured by Cytometry by time-of-flight (CyTOF) with residual cancer burden	Up to 12 months until death or a maximum of 20 years post registration
Generate autologous co-culture systems of peripheral blood immune cells and breast cancer tumor cells to study the endogenous antitumor immune response	Up to 12 months until death or a maximum of 20 years post registration

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Matthew P. Goetz, M.D., Mayo Clinic; Principal Investigator: Judy C. Boughey, M.D., Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2021
• Primary Completion (Estimated): January 15, 2041
• Study Completion (Estimated): January 15, 2042

Study Registration Dates

• First Submitted: January 7, 2021
• First Submitted That Met QC Criteria: January 7, 2021
• First Posted (Actual): January 11, 2021

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Therapeutics; Drug Therapy
• Other Study ID Numbers: MC1933

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No