Molecular Surveillance, Breast Cancer, ctDNA, MRD, Observational Study
Conditions
Brief summary
To learn about changes in ctDNA during the diagnosis, treatment, and post-treatment surveillance of EBC.
Detailed description
Primary Objectives To describe the dynamic changes of ctDNA by binary MRD status (positive/negative) using the Myriad Genetics Precise MRD assay during the spectrum of diagnosis, treatment (neoadjuvant and adjuvant), and post-therapy surveillance of EBC in subgroups of interest. Secondary Objectives To describe the dynamic changes of ctDNA by continuous quantitative tumor fraction using the Myriad Genetics Precise MRD assay during the spectrum of diagnosis, treatment (neoadjuvant and adjuvant), and post-therapy surveillance of EBC in subgroups of interest.
Interventions
DIAGNOSTIC_TESTBlood draw for the laboratory assessment
Blood will be drawn up to every cycle during neoadjuvant treatment
DRUGNeoadjuvant treatment
Given by IV
Sponsors
M.D. Anderson Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Eligibility Criteria * Men or women who have a diagnosis of histological confirmed EBC (stage I, II or III) of any histopathology and any subtype (hormone-receptor positive or negative, HER2-positive, or negative). * Have tumor tissue available of sufficient quality for processing by Myriad Genetics. * Participant must be willing to provide serial blood samples at specific timepoints specific for each subgroup of interest per the Schedule of Activities * Age ≥18 years at enrollment * Arm A: Participants undergoing neoadjuvant systemic therapy: those with newly diagnosed untreated EBC of any subtype, stage I-II-II, who are scheduled to receive neoadjuvant systemic therapy of any type (i.e. chemotherapy, targeted therapy, immunotherapy, endocrine therapy) including a combination of agents, prior to undergoing breast surgery * Arm B: Participants with TNBC or HER2-positive EBC (T1a, T1b, N0): those with newly diagnosed and untreated TNBC or HER2-positive EBC who have a plan to undergo upfront breast surgery as part of their standard of care treatment * Arm C: Participants who receive an adjuvant CDK4/6-inhibitor (i.e., abemaciclib or ribociclib): those who have a diagnosis of hormone-receptor positive, HER2-negative, stage I-II-III EBC who have a plan to receive adjuvant abemaciclib or adjuvant ribociclib as part of their standard of care treatment * Arm D: Participants who receive an adjuvant PARP-inhibitor (i.e., olaparib): those who have a germline pathogenic mutation (i.e. BRCA) and a diagnosis of hormone-receptor positive or negative, HER2-negative, stage I-II-III EBC, and have a plan to receive an adjuvant PARPinhibitor as part of their standard of treatment plan * Arm E: Participants who develop ipsilateral locoregional recurrence (ILRR): those who have a diagnosis of EBC of any subtype, stage I-II-II and have completed local therapy (i.e. breast surgery and/or radiation therapy) and develop biopsy-proven locoregional disease recurrence in the ipsilateral breast and/or ipsilateral regional nodal basins * Arm F: Participants who completed local therapy and are 5 or more years out from breast surgery: those who have a diagnosis of EBC of any subtype, stage I-II-II, and have completed local therapy (i.e. breast surgery and/or radiation therapy), and are 5 or more years out from local therapy and do not have clinical evidence of disease
Exclusion criteria
* Participants with distant cancer metastases (beyond locoregional disease recurrence) * Participants with cognitive impairment/psychiatric illness/social situations that would limit compliance with study requirements. * Current or recent (within the last year) diagnosis of another primary malignancy (except skin cancer and non-invasive cancer) * Personal history of allogenic bone marrow or organ transplant * Participants who are pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and adverse events (AEs). | Through study completion; an average of 1 year. | Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 |
Countries
United States
Contacts
CONTACTCarlos H Barcenas, MD
PRINCIPAL_INVESTIGATORCarlos H Barcenas, MD
M.D. Anderson Cancer Center
Outcome results
None listed