A Phase II Study of Dose-Dense Doxorubicin and Cyclophosphamide followed by Eribulin Mesylate for the Adjuvant Treatment of Early-Stage Breast Cancer

Protocol
10-190
Full Title
A Phase II, Single-Arm, Feasibility Study of Dose Dense Doxorubicin and Cyclophosphamide (AC) followed by Eribulin Mesylate for the Adjuvant Treatment of Early Stage Breast Cancer
Phase
II
Purpose

The purpose of this study is to evaluate the safety and effectiveness of the anticancer drug eribulin when added to standard chemotherapy given after surgery in women with early-stage breast cancer. Eribulin is a new chemotherapy drug approved for the treatment of advanced breast cancer that persists despite prior treatment, but its use for early-stage disease is considered investigational.

Eribulin, which is derived from a sea sponge, works by inhibiting microtubules (which provide scaffolding in cancer cells), leading to cell death. It is administered intravenously (by vein). In this study, eribulin will be given after one standard treatment for breast cancer with the drugs doxorubicin and cyclophosphamide.

Eligibility

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

  • Patients must have stage I-III breast cancer that has not yet been treated with any therapy other than surgery.
  • Patients must be candidates for chemotherapy.
  • Patients’ tumors must express normal levels of HER2.
  • 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.
  • 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 646-888-5209.

Disease(s)
Breast Cancer
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