Long Term Followup of Patients Enrolled in MC1137, BEAUTY Study

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Carcinoma

Intervention / Treatment
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* Procedure: Biospecimen Collection
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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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 Willingness to provide mandatory blood specimens for future research on breast cancer at Mayo Clinic Willingness to provide mandatory tissue specimens for future research on breast cancer at Mayo Clinic Willingness to provide consent for use of archived tumor biopsies obtained after enrollment in BEAUTY (Request tissue from prior biopsy of site of recurrence) Ability to complete questionnaires by themselves or with assistance 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational (biospecimen collection, questionnaire)<br>Patients undergo collection of blood samples and complete questionnaires throughout the study. Patients may also undergo the collection of tissue samples throughout the study. | Procedure: Biospecimen Collection<br>* Undergo collection of blood and tissue samples<br>* Other names: Specimen Collection;Other: Questionnaire Administration<br>* Complete questionnaire<br>|

What is the study measuring?
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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 |