Clonal Hematopoiesis as a Marker of Genetic Damage Following Adjuvant Chemotherapy for Breast Cancer: Pilot Study to Evaluate Incidence
Abstract
A serious late effect complication associated with breast cancer treatment is the increased risk for development of therapy-related hematologic malignancies. The goal of this study is to determine whether dose-intensive adjuvant regimens for breast cancer induce genetic damage to hematopoietic stem cells, defined by the emergence of clonal hematopoiesis. Clonal hematopoiesis has been proposed as an early marker of hematopoietic stem cell damage, preceding the acquisition of critical, recurring genetic alterations associated with the development of therapy-related myelodysplastic syndromes and acute leukemia. Clonal hematopoiesis is being evaluated by two different methods, the X-linked HUMARA clonality and microsatellite instability assays. All positive results will be further analyzed for MLL and RAS alterations. Study accomplishments to date: a) activation of ancillary biological protocol (S97l9) to treatment protocol (S9623), b) testing assays developed and standardized, c) specimen collection and data analysis of 123 samples from 21 patients completed, d) protocol amendment incorporating S9719 into the clinical treatment (S9623) protocol submitted and approved by DoD and CTEP to increase patient accrual, e) S9623/S9719 declared a high priority clinical trial by the NCI, f) 59719 protocol updates given at Southwest Oncology Group meetings, and g) presentation of data collected at the Era of Hope 2000 meeting.
Document Details
- Document Type
- Technical Report
- Publication Date
- Sep 01, 2000
- Accession Number
- ADA387873
Entities
People
- Charles A. Coltman