A Phase II Study of Weekly Paclitaxel with and without LCL161 in Women with Previously Untreated Triple-Negative Breast Cancer

Protocol
13-082
Full Title
A Phase II, Multi-center, Open-label, Neoadjuvant, Randomized Study of Weekly Paclitaxel With or Without LCL161 in Patients with Triple Negative Breast Cancer
Phase
II
Purpose

Triple-negative breast cancers do not express the HER2 protein nor contain estrogen or progesterone receptors. They can be challenging to treat. Doctors are therefore seeking more effective therapies for this disease.

The purpose of this study is to see if combining paclitaxel with LCL161 is more effective for treating triple-negative breast cancer than paclitaxel alone. LCL161 is an investigational drug that works by releasing the brakes on cell death. All normal cells undergo a process called “apoptosis,” or programmed cell death, but cancer cells lack this feature. LCL161 is designed block the inhibitors of apoptosis so cancer cells can die.

In prior laboratory studies, LCL161 and paclitaxel caused more cancer cells to die than paclitaxel given alone. LCL161 has also caused triple-negative breast cancer cells to die.

Patients in this study will be randomly assigned to receive LCL161 plus paclitaxel, or paclitaxel alone. Paclitaxel is given intravenously (by vein), while LCL161 is taken orally (by mouth). Researchers will also compare patients’ responses to therapy with the “genetic signatures” of their tumors.

Eligibility

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

  • Patients must have triple-negative breast cancer that has not yet been treated and has not spread (metastasized) to other parts of the body.
  • Patients should be candidates for breast cancer surgery (mastectomy or lumpectomy).
  • 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 open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Tiffany A. Traina at 646-888-5209.

Disease(s)
Breast Cancer
Locations
Related Diseases