A Phase II Study Evaluating Stereotactic Body Radiotherapy plus Standard Therapy versus Standard Therapy Alone in Patients with Oligometastatic Breast Cancer or Lung Cancer

Full Title

PROMISE-005: A Phase II Randomized Study Assessing the Efficacy of Stereotactic Body Radiotherapy (SBRT) in Patients with Oligometastatic Breast or Lung Cancer

Purpose

Triple-negative breast cancer (TNBC) and non-small cell lung cancer (NSCLC) that spread to other parts of the body (metastasize) are usually treated with chemotherapy, immunotherapy, targeted therapies, and/or radiation therapy. In this study, researchers want to see if using stereotactic body radiosurgery (SBRT) to all metastatic tumors plus standard therapy is more effective than standard therapy alone in patients with oligometastatic TNBC or NSCLC (five or fewer metastatic tumors).

SBRT is a form of radiation therapy in which high doses of radiation are given very precisely, typically over five or fewer treatments. In this study, patients will be randomly assigned to receive SBRT followed by standard therapy, or standard therapy alone.

Who Can Join

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

• Patients must have TNBC or NSCLC that has spread to one to five other sites in the body.
• Patients’ tumors may not have detectable molecular alterations in the EGFR, ALK, or ROS1 proteins. Patients with those alterations may be able to receive other treatments that target those proteins.
• Patients must be able to walk and do routine activities for more than half of their normal waking hours.
• This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. T. Jonathan Yang at 212-639-8157.