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Trial Title:
Long Term Followup of Patients Enrolled in MC1137, BEAUTY Study
NCT ID:
NCT05703399
Condition:
Breast Carcinoma
Conditions: Official terms:
Breast Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo collection of blood and tissue samples
Arm group label:
Observational (biospecimen collection, questionnaire)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Complete questionnaire
Arm group label:
Observational (biospecimen collection, questionnaire)
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.
Detailed 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 throughout the study. Patients may also
complete questionnaires and/or undergo the collection of tissue samples throughout the
study.
Criteria for eligibility:
Study pop:
Patients enrolled in BEAUTY (MC1137) and did not withdraw consent while enrolled on
BEAUTY for either specimen collection or long-term follow-up
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic in Arizona
Address:
City:
Scottsdale
Zip:
85259
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Investigator:
Last name:
Donald W. Northfelt, M.D.
Email:
Principal Investigator
Facility:
Name:
Mayo Clinic in Florida
Address:
City:
Jacksonville
Zip:
32224-9980
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Investigator:
Last name:
Sarah A. McLaughlin, M.D.
Email:
Principal Investigator
Facility:
Name:
Mayo Clinic in Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Investigator:
Last name:
Judy C. Boughey, M.D.
Email:
Principal Investigator
Start date:
January 27, 2023
Completion date:
December 31, 2033
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05703399
https://www.mayo.edu/research/clinical-trials
