A Phase II Study of Fulvestrant plus Abemaciclib in Recurrent or Persistent Hormone Receptor-Positive Endometrial Cancer

Full Title

IIT: Single Arm, Open-Label, Phase II Study of Fulvestrant in Combination with Abemaciclib in Hormone Receptor Positive Adenocarcinoma of Endometrium

Purpose

The purpose of this study is to assess the safety and effectiveness of giving two breast cancer drugs to women with hormone receptor-positive endometrial cancer that has continued to grow or came back after chemotherapy. The drugs are fulvestrant and abemaciclib.

Fulvestrant binds to receptors for estrogen on tumors and inhibits the ability of estrogen to dock at these sites. Estrogen can fuel the growth of endometrial cancer. Abemaciclib is designed to inhibit cancer growth by blocking cyclin-dependent kinases (CDK), enzymes which cancer cells need to grow and divide, including endometrial cancer.

Fulvestrant is given as an injection in the muscle and abemaciclib is taken orally (by mouth).

Eligibility

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

  • Patients must have endometrial cancer that has continued to grow or came back despite one or two prior regimens of chemotherapy.
  • At least 3 weeks must pass between the completion of prior treatments 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 women age 18 and older who are postmenopausal (due to age or prior medical treatment).

For more information and to inquire about eligibility for this study, please contact Dr. Vicky Makker at 646-888-4224.

Protocol

18-107

Phase

II

Investigator