Long Term Followup of Patients Enrolled in MC1137, BEAUTY Study

Mayo Clinic

Status: Enrolling

Conditions: Breast Carcinoma

Treatments: Procedure: Biospecimen Collection; Other: Questionnaire Administration

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT05703399

21-010580 (Other Identifier)

NCI-2022-09616 (Registry Identifier)

MC210301 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

140 participants in 1 patient group

Observational (biospecimen collection, questionnaire)

Description:

Patients undergo collection of blood samples throughout the study. Patients may also complete questionnaires and undergo the collection of tissue samples throughout the study.

Treatment:

Other: Questionnaire Administration

Procedure: Biospecimen Collection