Clinical Trials

A Phase II Study of Abraxane with or without Tigatuzumab in Patients with Metastatic Triple-Negative Breast Cancer

Protocol
11-082
Full Title
An Open Label, Randomized, Phase II Trial of AbraxaneTM (Paclitaxel Albumin-Bound Particles for Injectable Suspension), with or without Tigatuzumab (a Humanized Monoclonal Antibody Targeting Death Receptor 5) (CS-1008) in Patients with Metastatic, Triple Negative (ER, PR, and HER-2 Negative) Breast Cancer
Purpose

Breast cancers that don’t contain receptors for estrogen, progesterone, or HER2/NEU — called “triple-negative breast cancers” (TNBC) — are very difficult to treat successfully. Researchers are seeking new therapeutic targets for TNBC.

Abraxane is a form of paclitaxel that is commonly used to treat breast cancer. In this study, researchers are evaluating the safety and effectiveness of combining Abraxane with the investigational drug tigatuzumab in women with metastatic TNBC.

Tigatuzumab is an antibody that binds to a protein on TNBC cells called DR5 and causes cancer cell death. Laboratory studies have shown that tigatuzumab plus another chemotherapy agent, such as Abraxane, is more effective than either drug alone against breast cancer cells. In this study, patients will be randomly assigned to receive Abraxane with or without tigatuzumab.

A biopsy of each patient’s tumor may be required for research purposes.

Investigator
Tiffany A. Traina, MD
Tiffany A. Traina - Physician Profile
Eligibility

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

  • Patients must have a confirmed diagnosis of TNBC.
  • There is no limit on the number of prior chemotherapy regimens, but at least 3 weeks must have passed since completion of therapy and entry into the study. At least 1 week must have passed since receipt of radiation therapy and entry into the study.
  • Patients may not have previously received Abraxane for metastatic disease.
  • Patients must be able to be ambulatory for more than half of their normal waking hours.
  • Patients must be age 18 or older.

For more information about this study and to inquire about eligibility, please contact Dr. Tiffany A. Traina at 646-888-4558.

Disease(s)
Breast Cancer
Locations
Related Diseases