This phase I trial studies the side effects and the best dose of cisplatin when given together with radiation therapy in treating patients with stage II-III breast cancer that does not have estrogen receptors, progesterone receptors, or large amounts of human epidermal growth factor receptor 2 (HER2)/neu protein. Drugs used in chemotherapy, such as cisplatin, 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. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving cisplatin together with radiation therapy may kill more tumor cells.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01674842.
PRIMARY OBJECTIVES:
I. To assess the safety, tolerability, and maximum tolerated dose (MTD) of cisplatin when given concurrently with radiation therapy for participants with stage II or III breast cancer who have undergone breast conserving surgery.
SECONDARY OBJECTIVES:
I. To assess local recurrence at 5-years in participants receiving cisplatin concurrently with radiation (radiation therapy), as compared with historic controls receiving radiation without concurrent chemotherapy.
II. To assess long-term toxicity in participants receiving cisplatin concurrently with radiation.
OUTLINE: This is a dose-escalation study of cisplatin.
Patients receive cisplatin intravenously (IV) once weekly and undergo radiation therapy daily 5 days a week. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 3 months and then every 6 months for 5 years.
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorJennifer Ruth Bellon