Long Term Followup of Patients Enrolled in MC1137, BEAUTY Study

Recruiting

• Conditions: Breast Carcinoma
• Interventions: Procedure: Biospecimen Collection; Other: Questionnaire Administration

• Registration Number: NCT05703399
• Lead Sponsor: Mayo Clinic

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.

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-12-27
• Study First Submitted QC: 2023-01-18
• Study Start: 2023-01-27
• Study First Posted: 2023-01-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-09
• Last Update Posted: 2024-07-10
• Primary Completion: 2032-12-31
• Study Completion: 2033-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational (biospecimen collection, questionnaire)	Biospecimen Collection	Patients undergo collection of blood samples throughout the study. Patients may also complete questionnaires and undergo the collection of tissue samples throughout the study.
Observational (biospecimen collection, questionnaire)	Questionnaire Administration	Patients undergo collection of blood samples throughout the study. Patients may also complete questionnaires and undergo the collection of tissue samples throughout the study.

Primary Outcome Measures

Name	Time	Method
Identification of mechanisms of treatment resistance and to study new drugs/drug combinations	Up to 10 years following study entry	Will develop and use PDX models from recurrent breast cancer to identify mechanisms of treatment resistance and to study new drugs/drug combinations.
Endogenous antitumor immune response and immune evasion mechanisms	Up to 10 years following study entry	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
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
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	Up to 10 years following study entry	Using RareCyte CTC technology
Association with breast cancer disease-free interval	Up to 10 years following study entry
Changes in the genomic and proteomic landscape over time	Up to 10 years following study entry	Will evaluate changes in the genomic and proteomic landscape over time, by sequencing recurrent disease and comparing with sequencing data from the primary tumor.
Assess Spatial immune micro-landscapes of pre-treatment and treated tumors	Up to 10 years following study entry	High-plex digital spatial profiling will be used to evaluate immune biomarkers

Trial Locations

Locations (3)

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States