Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-09616 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| MC210301 | Other Identifier | Mayo Clinic in Rochester | |
| 21-010580 | Other Identifier | Mayo Clinic Institutional Review Board |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational (biospecimen collection, questionnaire) | Patients undergo collection of blood samples throughout the study. Patients may also complete questionnaires and undergo the collection of tissue samples throughout the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo collection of blood and tissue samples |
|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Patients enrolled in BEAUTY (MC1137) and did not withdraw consent while enrolled on BEAUTY for either specimen collection or long-term follow-up
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Judy C. Boughey, M.D. | Mayo Clinic in Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | United States | ||
| Mayo Clinic in Florida |
Not provided
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
Not provided
Not provided
Not provided
Not provided
Not provided
| Questionnaire Administration | Other | Complete questionnaire |
|
| 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 |
| Jacksonville |
| Florida |
| 32224-9980 |
| United States |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| D017437 |
| Skin and Connective Tissue Diseases |