A Phase IB Study of LY2835219 plus Hormonal Therapy in Women with Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer

Protocol
14-085
Full Title
A Phase 1b Study of LY2835219 in Combination with Endocrine Therapies for Patients with Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer
Phase
I
Purpose

The purpose of this study is to evaluate treatment with the investigational drug LY2835219 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. LY2835219 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 LY2835219 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.

Disease(s)
Breast Cancer
Locations
Related Diseases