Collection of Specimens and Clinical Data for Patients Wi... | NCT06217874

Studies
Collection of Specimens and Clinical Data for Patients With Recurrent or Metastatic Breast Cancer or Male Breast Cancer

NCT06217874

Sponsor

Mayo Clinic

Status

Recruiting

Last Update Posted

Feb 25, 2026Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Breast Carcinoma
Metastatic Breast Carcinoma
Recurrent Breast Carcinoma

Interventions

Non-Interventional Study

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

ID	Type	Description	Link
NCI-2023-10076	Registry Identifier	CTRP (Clinical Trial Reporting Program)
14-002919	Other Identifier	Mayo Clinic in Rochester

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

Jun 5, 2014Actual

Primary Completion Date

Jun 30, 2034Estimated

Completion Date

Jun 30, 2034Estimated

First Submitted Date

Jan 3, 2024

First Submission Date that Met QC Criteria

Jan 11, 2024

First Posted Date

Jan 23, 2024Actual

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 23, 2026

Last Update Posted Date

Feb 25, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is being done to create a resource of samples and information that can be used to improve our understanding of the development, progression and treatment of recurrent or metastatic breast cancer or male breast cancer.

Detailed Description

PRIMARY OBJECTIVE:

I. To collect blood samples and fresh tissue from biopsies of metastatic lesions from Mayo Clinic patients with metastatic breast cancer.

OUTLINE: This is an observational study.

Patients undergo blood sample collection, provide clinical residual tissue samples and have their medical records reviewed on study.

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

2,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Observational		Patients undergo blood sample collection, provide clinical residual tissue samples and have their medical records reviewed on study.	Other: Non-Interventional Study

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Non-Interventional Study	Other	Non-interventional study	Observational

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Response to targeted therapies	Response to targeted therapies will be evaluated in organoid or mouse xenograft models derived from tumor biospecimens obtained from participants.	Baseline
Change in tumor cells	Changes in tumor cells will be evaluated following metastasis to other organs and after various treatments.	Baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female participants must have histologically or cytologically confirmed invasive breast cancer.
Male participants must have biopsy proven breast cancer.
Age must be >= 18 years, and all must be able to understand and willing to sign an informed consent document.

Exclusion Criteria:

Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent; a history of serious or life-threatening allergic reaction to local anesthetics (i.e. lidocaine, xylocaine).
Any other condition, which in the opinion of the patient's treating oncologist, or the physician performing the biopsy procedure, would make participation in this protocol unreasonably hazardous for the patient.

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 with invasive cancer, suspected or known recurrent or metastatic lesions, as well as males with biopsy proven breast cancer

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Fergus J. Couch, Ph.D.	Mayo Clinic in Rochester	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic in Rochester	Recruiting	Rochester	Minnesota	55905	United States

Label	URL
Mayo Clinic Clinical Trials	View source

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Description

Tissue specimens will be frozen and stored in the Biospecimen Accessioning and Processing Lab at Mayo Clinic Rochester. Part of the tissue specimen may be grown in the lab as organoids, which can be used to test drug responses, and some may be used to make xenografts-a process where part of the specimen is injected into mice to grow a new tumor used for future sequencing and drug studies.