Long Term Followup of Patients Enrolled in MC1137, BEAUTY Study

NCT05703399 | Active Not Recruiting DMC

• 3 other identifiers: MC210301NCI-2022-0961621-010580
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 3

Brief Summary

This study gathers information and samples for further analysis as part of the BEAUTY study. The purpose of the BEAUTY study was to better understand the reasons why or why not breast cancers respond to standard chemotherapy. Collecting samples of blood and tissue and health and treatment information from patients on the BEAUTY study may help doctors identify changes that make cancer better respond to standard chemotherapy and develop better therapies for the treatment of cancer.

Conditions

Breast Carcinoma

Outcome Measures

Primary Outcomes (8)

• Association of residual cancer burden and breast cancer disease-free interval

  Up to 10 years following study entry

• Trajectory of CTC and ctDNA over time after breast cancer treatment

  Using RareCyte CTC technology

  Up to 10 years following study entry

• Association with breast cancer disease-free interval

  Up to 10 years following study entry

• Association of peripheral blood immune phenotype (circulating immune cell subpopulations as measured by CyTOF) over time with breast cancer disease-free interval

  Up to 10 years following study entry

• Identification of mechanisms of treatment resistance and to study new drugs/drug combinations

  Will develop and use PDX models from recurrent breast cancer to identify mechanisms of treatment resistance and to study new drugs/drug combinations.

  Up to 10 years following study entry

• Changes in the genomic and proteomic landscape over time

  Will evaluate changes in the genomic and proteomic landscape over time, by sequencing recurrent disease and comparing with sequencing data from the primary tumor.

  Up to 10 years following study entry

• Assess Spatial immune micro-landscapes of pre-treatment and treated tumors

  High-plex digital spatial profiling will be used to evaluate immune biomarkers

  Up to 10 years following study entry

• Endogenous antitumor immune response and immune evasion mechanisms

  Will generate autologous co-culture systems of peripheral blood immune cells and breast cancer tumor cells to study the endogenous antitumor immune response and immune evasion mechanisms

  Up to 10 years following study entry

Study Arms (1)

Observational (biospecimen collection, questionnaire)

Patients undergo collection of blood samples throughout the study. Patients may also complete questionnaires and undergo the collection of tissue samples throughout the study.

Procedure: Biospecimen Collection; Other: Questionnaire Administration

Interventions

Biospecimen Collection PROCEDURE

Undergo collection of blood and tissue samples

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Observational (biospecimen collection, questionnaire)

Questionnaire Administration OTHER

Complete questionnaire

Observational (biospecimen collection, questionnaire)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients enrolled in BEAUTY (MC1137) and did not withdraw consent while enrolled on BEAUTY for either specimen collection or long-term follow-up

You may qualify if:

• REGISTRATION - FOR PATIENTS STILL ALIVE:
• Enrolled in BEAUTY \[MC1137 (NCT02022202)\] and did not withdraw consent while enrolled on BEAUTY for either specimen collection or long-term follow-up
• Able to provide written informed consent
• REGISTRATION - FOR PATIENTS WHO HAVE DIED:
• Enrolled in MC1137 and did not withdraw consent while enrolled on BEAUTY for either specimen collection or long-term follow-up
• Existence of a family member willing to provide consent for use of archived tumor biopsies obtained after enrollment in BEAUTY

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (3)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Judy C. Boughey, M.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: December 27, 2022
• First Posted: January 30, 2023
• Study Start: January 27, 2023
• Primary Completion (Estimated): July 31, 2034
• Study Completion (Estimated): July 31, 2034
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

US (3)