A Phase IB Study of Abemaciclib plus Hormonal Therapy in Women with Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer

Full Title

A Phase 1b Study of Abemaciclib in Combination with Therapies for Patients with Metastatic Breast Cancer

Purpose

The purpose of this study is to evaluate treatment with the investigational drug abemaciclib in addition to hormonal therapy in women with metastatic breast cancer that is positive for hormone receptors (such as receptors for estrogen and progesterone) and negative for the HER2 protein. Abemaciclib is designed to inhibit cancer growth by blocking cyclin-dependent kinases (CDK), enzymes which cancer cells need to grow and divide.

Patients in this study will be treated with abemaciclib plus a standard hormonal therapy (such as letrozole, exemestane, tamoxifen, or anastrozole). Some patients receiving exemestane may also receive the drug everolimus, which helps prevent the tumor from developing resistance to hormonal therapy.

All of the medications in this study are taken orally (by mouth).

Eligibility

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

  • Patients in this study must be women with metastatic breast cancer that is positive for hormone receptors and negative for the HER2 protein.
  • Patients must be postmenopausal, due to age or to prior treatment.
  • With the exception of ongoing hormonal therapy, at least 2 to 3 weeks must have passed since completion of prior therapies and entry into the study. Patients may not have previously received chemotherapy for metastatic disease.
  • 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.

For more information about this study and to inquire about eligibility, please contact Dr. Maura Dickler at 646-888-5456.

Protocol

14-085

Phase

I

Investigator

Co-Investigators

Diseases

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