Long Term Followup of Patients Enrolled in MC1137, BEAUTY Study

MC210301: Long Term Followup of Patients Enrolled in MC1137 (BEAUTY)

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Carcinoma
• Intervention / Treatment: Other: Questionnaire Administration; Procedure: Biospecimen Collection

Detailed Description

PRIMARY OBJECTIVES:

I. Evaluate the association of residual cancer burden and breast cancer disease-free interval.

II. Evaluate the trajectory of circulating tumor cell (CTC) and circulating tumor-deoxyribonucleic acid (ctDNA) over time after breast cancer treatment and the association with breast cancer disease-free interval.

III. Evaluate the association of peripheral blood immune phenotype (circulating immune cell subpopulations as measured by cytometry by time-of-flight [CyTOF]) over time with breast cancer disease-free interval.

IV. Develop and use patient derived xenograft (PDX) models from recurrent breast cancer to identify mechanisms of treatment resistance and to study new drugs/drug combinations.

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

VI. Assess the spatial immune micro-landscapes of pre-treatment and treated tumors.

VII. 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.

OUTLINE:

Patients undergo collection of blood samples and complete questionnaires throughout the study. Patients with cancer recurrence also undergo the collection of tissue samples throughout the study.

• Study Type: Observational
• Enrollment (Estimated): 140

Contacts and Locations

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

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Recruiting
      • Mayo Clinic in Arizona
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
      • Principal Investigator: Donald W. Northfelt, M.D.
  • Florida
    • Jacksonville, Florida, United States, 32224-9980
      • Recruiting
      • Mayo Clinic in Florida
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
      • Principal Investigator: Sarah A. McLaughlin, M.D.
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Principal Investigator: Judy C. Boughey, M.D.
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

Inclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational (biospecimen collection, questionnaire); Patients undergo collection of blood samples and complete questionnaires throughout the study. Patients may also undergo the collection of tissue samples throughout the study.	Other: Questionnaire Administration; Complete questionnaire; Procedure: Biospecimen Collection; Undergo collection of blood and tissue samples; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Judy C. Boughey, M.D., Mayo Clinic in Rochester

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2023
• Primary Completion (Estimated): December 31, 2032
• Study Completion (Estimated): December 31, 2033

Study Registration Dates

• First Submitted: December 27, 2022
• First Submitted That Met QC Criteria: January 18, 2023
• First Posted (Actual): January 30, 2023

Study Record Updates

• Last Update Posted (Actual): July 1, 2024
• Last Update Submitted That Met QC Criteria: June 27, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: MC210301 (Other Identifier: Mayo Clinic in Rochester); NCI-2022-09616 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No