Full Title15-102-14: A Phase 3 Open-Label, Randomized, Multicenter Study of NKTR-102 versus Treatment of Physicians Choice (TPC) in Patients with Metastatic Breast Cancer who have Stable Brain Metastases and have been Previously Treated with an Anthracycline, a Taxane, and Capecitabine
The purpose of this study is to see if an investigational drug called NKTR-102 is better than standard chemotherapy for previously treated patients with metastatic breast cancer who have stable brain metastases. NKTR-102 slowly releases the anticancer drug irinotecan into the blood, enabling it to stay in the bloodstream longer. Irinotecan inhibits an enzyme that cancer cells need to duplicate their DNA and reproduce.
Patients in this study will receive either NKTR-102 or their physician’s choice of standard chemotherapy. NKTR-102 is given intravenously (by vein).
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have metastatic breast cancer that has spread to the brain, and the brain metastases have stopped growing.
- Patients must have previously received whole-brain and/or stereotactic radiation therapy for brain metastases.
- Patients must have received prior treatment with an anthracycline, taxane, and capecitabine.
- At least 2 weeks must pass between the completion of prior therapy and entry into the study.
- Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
- This study is for patients age 18 and older.
For more information about this study and to inquire about eligibility, please contact Dr. Andrew Seidman at 646-888-4559.