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

NCT06217874 | Recruiting

• 2 other identifiers: 14-002919NCI-2023-10076
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Breast Carcinoma; Breast Carcinoma; Metastatic Breast Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Observational

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

Other: Non-Interventional Study

Interventions

Non-Interventional Study OTHER

Non-interventional study

Observational

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Fergus J. Couch, Ph.D.

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: January 23, 2024
• Study Start: June 5, 2014
• Primary Completion (Estimated): June 30, 2034
• Study Completion (Estimated): June 30, 2034
• Last Updated: February 25, 2026

Record last verified: 2026-02

Locations

US (1)