This phase II trial tests how well genetically-guided radiotherapy works in treating triple negative breast cancer patients undergoing an operation to remove their tumor but not the breast itself (breast conservation surgery). In this study, patients' tumor tissue is collected and tested for certain genes to calculate the risk of cancer recurrence (“high risk” or “low risk”) and determine the amount of radiotherapy patients should receive. Radiotherapy in this trial uses high energy x-rays or electron beams to kill cancer cells and shrink tumors. Giving genetically-guided radiotherapy may be feasible and effective in controlling triple-negative breast cancer following breast conservation surgery.
Additional locations may be listed on ClinicalTrials.gov for NCT05528133.
Locations matching your search criteria
United States
Florida
Clearwater
Morton Plant HospitalStatus: Active
Contact: Ronica Hazariwala Nanda
Tampa
Moffitt Cancer CenterStatus: Active
Contact: Kamran Ahmed
Phone: 813-745-3320
PRIMARY OBJECTIVE:
I. To determine the three year local failure following genomically guided dose personalization in the management of triple negative (TN) breast cancer following breast conservation therapy (BCT).
SECONDARY OBJECTIVES:
I. To determine the overall survival (OS) following genomically guided dose personalization in the management of TN breast cancer following BCT.
II. To determine the progression free survival (PFS) following genomically guided dose personalization in the management of TN breast cancer following BCT.
III. To determine the distant control (DC) rate following genomically guided dose personalization in the management of TN breast cancer following BCT.
IV. To determine quality of life (QOL) following genomically guided dose personalization in the management of TN breast cancer following BCT.
TERTIARY OBJECTIVE:
I. To determine mutational changes that lead to difference in local control and toxicity in the management of TN breast cancer following BCT.
II. Assess differences in radiosensitivity index (RSI) between archival formalin-fixed paraffn-embedded (FFPE) and fresh frozen tissue with correlation to OS, PFS, DC, and QOL.
OUTLINE: Patients are assigned to 1 of 2 arms based on results of RSI testing.
ARM I: Patients undergo whole breast radiotherapy without a boost to the tumor cavity on study.
ARM II: Patients undergo whole breast radiotherapy with a boost to the tumor cavity on study.
All patients also undergo collection of blood samples, mammograms, and computed tomography (CT) and/or magnetic resonance imaging (MRI) scans throughout the trial. Patients may also undergo a tumor biopsy during screening as clinically indicated.
After completion of study intervention, patients are followed up at week 9, then every 6 months for the first 3 years, and then annually for years 3-5.
Lead OrganizationMoffitt Cancer Center
Principal InvestigatorKamran Ahmed