Long Term Followup of Patients Enrolled in MC1137, BEAUTY Study

Breast Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05703399
• Other study ID #: MC210301
• Secondary ID: NCI-2022-09616MC
• Status: Recruiting
• Start date: January 27, 2023
• Est. completion date: December 31, 2033

Study information

• Verified date: December 2023
• Source: Mayo Clinic
• Contact: Clinical Trials Referral Office
• Phone: 855-776-0015
• Email: mayocliniccancerstudies[@]mayo.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 and complete questionnaires throughout the study. Patients with cancer recurrence also undergo the collection of tissue samples throughout the study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 31, 2033
• Est. primary completion date: December 31, 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms

Intervention

Procedure:
• Biospecimen Collection
Undergo collection of blood and tissue samples

Other:
• Questionnaire Administration
Complete questionnaire

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida
United States	Mayo Clinic in Rochester	Rochester	Minnesota
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association of residual cancer burden and breast cancer disease-free interval		Up to 10 years following study entry
Primary	Trajectory of CTC and ctDNA over time after breast cancer treatment	Using RareCyte CTC technology	Up to 10 years following study entry
Primary	Association with breast cancer disease-free interval		Up to 10 years following study entry
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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

External Links

•   Mayo Clinic Clinical Trials