A Phase II Study of Trastuzumab Emtansine versus Trastuzumab/Paclitaxel in Women with Stage I HER2-Positive Breast Cancer

Full Title

A Randomized Phase II Study of Adjuvant Trastuzumab Emtansine (T-DM1) vs. Paclitaxel in Combination with Trastuzumab for Stage I HER2-Positive Breast Cancer (ATEMPT Trial)

Purpose

Trastuzumab (Herceptin) is an anticancer drug used to treat women with early-stage and advanced breast cancer that produces HER2, a protein on the surface of some breast cancer cells that provides messages telling these cells to grow. Trastuzumab may be combined with paclitaxel (Taxol), another anticancer drug. Since this combination of therapies can cause unpleasant side effects, doctors are seeking other effective treatments that are more tolerable.

Trastuzumab emtansine (Kadcyla) is a form of trastuzumab attached to a chemotherapy drug. It is used to treat women with advanced HER2-positive breast cancer. Researchers in this study are comparing trastuzumab emtansine with standard trastuzumab/paclitaxel therapy in women with stage I HER2-positive breast cancer.

Patients will be randomly assigned to receive one therapy or the other after breast cancer surgery. In addition to comparing the effectiveness of the two treatments, researchers will ask participants about their quality of life and symptoms while on therapy, to see if one treatment is better tolerated than the other.

Eligibility

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

  • Patients must have stage I HER2-positive breast cancer.
  • Breast cancer surgery must have taken place 90 days or less before entering the study.
  • At least 5 years must have passed since any prior chemotherapy. Patients may not have received prior paclitaxel therapy.
  • 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. Chau Dang at 646-888-5426.

Protocol

14-221

Phase

II

Investigator

Co-Investigators

Diseases