A Phase II Study of DS-8201A in Patients with HER2-Positive Inoperable or Metastatic Breast Cancer

Full Title

DS8201-A-U201: A Phase 2, Multicenter, Open-Label Study of DS-8201a, an Anti-HER2-Antibody Drug Conjugate (ADC) for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated with T-DM1


DS-8201A is an investigational drug that targets a protein on some cancer cells called HER2. It consists of an antibody which attaches to the HER2 receptor, and a chemotherapy drug that is then released to kill the cancer cell.

In this study, researchers are evaluating the effects on the body of three different doses of DS-8201A in patients with inoperable or metastatic HER2-positive breast cancer that continues to grow despite treatment with another HER2-targeting drug called trastuzumab emtansine (T-DM1). DS-8201A 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 HER2-positive inoperable or metastatic breast cancer that continues to grow despite treatment with trastuzumab emtansine.
  • Patients must recover from the serious side effects of prior therapies.
  • Patients cannot have cancer that spread to the brain or spinal cord.
  • Patients must have tumor tissue available for re-testing of their HER2 status
  • 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. Shanu Modi at 646-888-4564.