This pilot clinical trial studies the side effects of accelerated partial breast irradiation using proton beam scanning and to see how well it works before surgery in treating patients with triple-negative breast cancer. Accelerated partial breast irradiation using proton beam scanning administered in higher doses over a shorter time period may help stop cancer from growing while protecting normal tissue cells.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03340402.
PRIMARY OBJECTIVES:
I. To establish the rate of grade >= 3 acute dermatitis using Common Terminology Criteria for Adverse Events (CTCAE) version (v)4 in patients with stage I triple negative breast cancer (TNBC) who receive dose-intense accelerated partial breast irradiation (APBI) with proton beam scanning (PBS) in the pre-operative setting.
SECONDARY OBJECTIVES:
I. To describe the margins needed around the gross tumor volume (GTV) in patients with stage I TNBC who receive dose-intense APBI with PBS in the pre-operative setting.
II. To describe the toxicity of treatment using CTCAE v4.
III. To estimate the pathological tumor response rates and surgical margin status after dose-intense APBI with PBS.
IV. To analyze local and regional failure rates and failure patterns following APBI.
V. To explore biomarkers of radiation response on pre- and post-operative tumor/blood research specimens.
OUTLINE:
Patients undergo accelerated partial breast irradiation using proton beam scanning once daily (QD) for 5 days before standard of care surgery in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6 months for 2 years, and then annually for a total of 3 years.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorRachel B. Jimenez