Clinical trial NCT05703399: Long Term Followup of Patients Enrolled in MC1137, BEAUTY Study
Official title: Long Term Followup of Patients Enrolled in MC1137 (BEAUTY)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Carcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-01-30
Enrollment: 140
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients enrolled in BEAUTY (MC1137) and did not withdraw consent while enrolled on BEAUTY for either specimen collection or long-term follow-up

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.

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.

Eligibility 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

Primary outcomes:
measure: Association of residual cancer burden and breast cancer disease-free interval
timeFrame: Up to 10 years following study entry
measure: Trajectory of CTC and ctDNA over time after breast cancer treatment
timeFrame: Up to 10 years following study entry
measure: Association with breast cancer disease-free interval
timeFrame: Up to 10 years following study entry
measure: Association of peripheral blood immune phenotype (circulating immune cell subpopulations as measured by CyTOF) over time with breast cancer disease-free interval
timeFrame: Up to 10 years following study entry
measure: Identification of mechanisms of treatment resistance and to study new drugs/drug combinations
timeFrame: Up to 10 years following study entry
measure: Changes in the genomic and proteomic landscape over time
timeFrame: Up to 10 years following study entry
measure: Assess Spatial immune micro-landscapes of pre-treatment and treated tumors
timeFrame: Up to 10 years following study entry
measure: Endogenous antitumor immune response and immune evasion mechanisms
timeFrame: Up to 10 years following study entry
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Judy C. Boughey, M.D.
role: PRINCIPAL_INVESTIGATOR
References: