This phase II trial studies how well boost radiation therapy before surgery works in treating patients with breast cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving boost radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Studying samples of tissue in the laboratory from patients undergoing boost radiation therapy before and after surgery may help doctors learn more about the effects of boost radiation of cells. It may also help doctors understand how well patients respond to treatment.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02482389.
PRIMARY OBJECTIVES:
I. Determine physician and patient-reported rates of good/excellent cosmesis at baseline and 6 months, 1, 2, and 3 years post-treatment as measured by the National Surgical Adjuvant Breast and Bowel Project (NSABP), the Radiation Therapy Oncology Group (RTOG), and the Gynecologic Oncology Group (GOG) (NRG) cosmesis scale.
SECONDARY OBJECTIVES:
I. Evaluate changes in circulating free deoxyribonucleic acid (DNA) pre and post-radiation in order to identify potential blood based radiation response biomarkers.
II. Assess patient-reported Quality of Life (Functional Assessment of Cancer Therapy-Breast [FACT-B]) and patient satisfaction at the same time points as above (primary objective).
III. Assess local control in the treated breast relative to historical controls.
IV. To review treatment plans, evaluate delivery techniques, and assess positioning verification images.
OUTLINE:
Patients undergo radiation therapy followed by lumpectomy 2-4 days later.
After completion of study treatment, patients are followed up every 4-6 months for 2 years, every 6-12 months for 3 years and annually for 5 years.
Lead OrganizationDuke University Medical Center
Principal InvestigatorRachel C. Blitzblau
