Long Term Followup of Patients Enrolled in MC1137, BEAUTY Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
PRIMARY OBJECTIVES:
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Evaluate the association of residual cancer burden and breast cancer disease-free interval.
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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.
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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.
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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.
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Evaluate changes in the genomic and proteomic landscape over time, by sequencing recurrent disease and comparing with sequencing data from the primary tumor.
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Assess the spatial immune micro-landscapes of pre-treatment and treated tumors.
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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 Design
Arms and Interventions
| Arm | 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. |
Procedure: Biospecimen Collection
Undergo collection of blood and tissue samples
Other Names:
Other: Questionnaire Administration
Complete questionnaire
|
Outcome Measures
Primary Outcome Measures
- 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]
- 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 [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.
- 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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REGISTRATION - FOR PATIENTS STILL ALIVE:
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Enrolled in BEAUTY (MC1137 [NCT02022202]) and did not withdraw consent while enrolled on BEAUTY for either specimen collection or long-term follow-up
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Able to provide written informed consent
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Willingness to provide mandatory blood specimens for future research on breast cancer at Mayo Clinic
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Willingness to provide mandatory tissue specimens for future research on breast cancer at Mayo Clinic
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Willingness to provide consent for use of archived tumor biopsies obtained after enrollment in BEAUTY (Request tissue from prior biopsy of site of recurrence)
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Ability to complete questionnaires by themselves or with assistance
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REGISTRATION - FOR PATIENTS WHO HAVE DIED:
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Enrolled in MC1137 and did not withdraw consent while enrolled on BEAUTY for either specimen collection or long-term follow-up
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Existence of a family member willing to provide consent for use of archived tumor biopsies obtained after enrollment in BEAUTY
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic in Arizona | Scottsdale | Arizona | United States | 85259 |
| 2 | Mayo Clinic in Florida | Jacksonville | Florida | United States | 32224-9980 |
| 3 | Mayo Clinic in Rochester | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Judy C Boughey, Mayo Clinic in Rochester
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MC210301
- NCI-2022-09616
- MC210301
- P30CA015083