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NCT Number: NCT05703399

Long Term Followup of Patients Enrolled in MC1137, BEAUTY Study

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Arizona, Scottsdale, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biospecimen Collection

Procedure

Undergo collection of blood and tissue samples

Other names: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Questionnaire Administration

Other

Complete questionnaire

Primary outcomes

  1. Association of residual cancer burden and breast cancer disease-free interval

    Time frame: Up to 10 years following study entry

  2. Trajectory of CTC and ctDNA over time after breast cancer treatment

    Time frame: Up to 10 years following study entry

    Using RareCyte CTC technology

  3. Association with breast cancer disease-free interval

    Time frame: Up to 10 years following study entry

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

    Time frame: Up to 10 years following study entry

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

    Time frame: 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.

  6. Changes in the genomic and proteomic landscape over time

    Time frame: 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.

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

    Time frame: Up to 10 years following study entry

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

  8. Endogenous antitumor immune response and immune evasion mechanisms

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Long Term Followup of Patients Enrolled in MC1137 (BEAUTY)

Important dates

Study start
2023
Primary completion
2034
Study completion
2034
First posted
Jan 30, 2023
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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