Development of Patient Derived Xenografts (PDX) in Patien... | NCT04703244

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

NCT04703244

Sponsor

Mayo Clinic

Status

Recruiting

Last Update Posted

Mar 3, 2026Actual

Enrollment

999Estimated

Phase

Not provided

Conditions

Breast Cancer
Residual

Interventions

chemotherapy or endocrine therapy for breast cancer

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 13, 2021Actual

Primary Completion Date

Jan 15, 2041Estimated

Completion Date

Jan 15, 2042Estimated

First Submitted Date

Jan 7, 2021

First Submission Date that Met QC Criteria

Jan 7, 2021

First Posted Date

Jan 11, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 27, 2026

Last Update Posted Date

Mar 3, 2026Actual

Description Module

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 death.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

999Estimated

Name	Type	Description	Arm Group Labels	Other Names
chemotherapy or endocrine therapy for breast cancer	Procedure	Collect blood and leftover surgical tissue from patients with breast cancer remaining after chemotherapy or endocrine therapy is completed.

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Name	Affiliation	Role
Judy C. Boughey, M.D.	Mayo Clinic	Principal Investigator
Matthew P. Goetz, M.D.	Mayo Clinic	Principal Investigator

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases