A Phase 1b/2 Study of Lenvatinib, Pembrolizumab, and Fulvestrant in People With Advanced Breast Cancer


Full Title

A Phase Ib/II trial of Lenvatinib plus Pembrolizumab plus Fulvestrant in ER-positive/ HER2-negative Metastatic Breast Cancer


Researchers are assessing the effectiveness of the combination of lenvatinib, pembrolizumab immunotherapy, and fulvestrant to treat advanced breast cancer. The people in this study have inoperable or metastatic breast cancer (cancer that has spread) that is estrogen receptor-positive and HER2-negative.

Lenvatinib blocks proteins that promote cancer cell growth and survival. Pembrolizumab boosts the power of the immune system to find and kill cancer cells. Fulvestrant is a hormonal therapy that decreases the amount of estrogen. It may slow or stop the growth of breast cancer cells that need estrogen to grow.

Lenvatinib is taken orally (by mouth). Pembrolizumab is given intravenously (by vein). Fulvestrant is given as an injection into the buttocks.

Who Can Join

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

  • Have inoperable or metastatic breast cancer that keeps growing even after treatment.
  • Have breast cancer that is estrogen receptor-positive and HER2-negative. 
  • Have not gotten more than 2 regimens of chemotherapy for metastatic breast cancer.
  • Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
  • Be age 18 or older.


For more information and to see if you can join this study, please call 646-497-9064




Phase I/II (phases 1 and 2 combined)

Disease Status

Relapsed or Refractory




ClinicalTrials.gov ID