A Phase 2 Study of REM-001 Photodynamic Therapy for Cutaneous Metastatic Breast Cancer


Full Title

An Open-Labeled, Single Arm Phase 2 Efficacy and Safety Study of REM-001 Photodynamic Therapy (PDT) for Treatment of Cutaneous Metastatic Breast Cancer (CMBC) that is Refractory or Not Eligible for Radiotherapy or Surgery (Advarra)


The purpose of this study is to see how well REM-001 works against advanced breast cancer that affects the skin. The people in this study have breast cancer that has metastasized (spread) and is causing skin lesions. Their lesions cannot be treated with surgery or radiation therapy.

REM-001 is a form of photodynamic therapy. It is a drug that is given intravenously (by vein). After you get the drug, a special light is applied to the skin lesions. The light activates the drug to kill cancer cells. You will also get standard chemotherapy during the study.

Who Can Join

To join this study, there are a few conditions. You must:

  • Have breast cancer that has spread to the skin and cannot be treated with surgery or radiation therapy.
  • Have cancer that keeps growing even with at least 2 prior regimens of anti-cancer drugs.
  • Be on a stable regimen of cancer therapy for the last 3 months.
  • Be able to walk and do routine activities for more than half the time you are awake.
  • Be age 18 or older.


For more information and to see if you can join this study, please call Dr. Alina Markova’s office at 646-608-2342.




Phase II (phase 2)




ClinicalTrials.gov ID