This randomized phase II trial studies how well radiation therapy and sequential or concurrent combination chemotherapy works in treating patients with early stage breast cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Trastuzumab is a form of “targeted therapy” because it works by attaching itself to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by the body’s immune system. It is not yet known whether radiation therapy is more effective with sequential or concurrent combination chemotherapy in treating early stage breast cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01928589.
PRIMARY OBJECTIVE:
I. Non-inferiority of partial breast irradiation (PBI) and concurrent compared to sequential chemotherapy with respect to acute grade 3-4 radiation toxicity.
SECONDARY OBJECTIVES:
I. Evaluate and compare any first tumor recurrence (local plus distant) between arms of the study.
II. Evaluate long term skin toxicity with concurrent chemotherapy and compare between arms of the study.
III. Evaluate and compare ipsilateral breast tumor reocurrence (IBTR), local recurrence, distant recurrence, and disease free survival.
IV. Give a description of the risks and benefits observed in each arm of the study over the duration of the trial.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo external beam radiation therapy (EBRT) once daily (QD) on weekdays for a total of 15 fractions. After completion of EBRT, patients receive cyclophosphamide and doxorubicin hydrochloride; docetaxel, cyclophosphamide and doxorubicin hydrochloride; docetaxel and cyclophosphamide; docetaxel, carboplatin, and trastuzumab; or paclitaxel and trastuzumab at the discretion of the treating Medical Oncologist.
ARM II: Patients undergo EBRT as in Arm I. Within 7 days of the start of radiation therapy, patients also receive combination chemotherapy as in Arm I. Patients also undergo mammography throughout the study.
After completion of study treatment, patients are followed up at 1-2 weeks, 3-4 months, 6-7 months, every 6 months for years 1-3, and every 6-12 months for years 3-5. Patients also undergo mammography throughout the study.
Lead OrganizationIndiana University/Melvin and Bren Simon Cancer Center
Principal InvestigatorRichard C. Zellars
