A Randomized Phase II Study of Partial Breast Irradiation and Sequential vs. Concurrent Chemotherapy in Women with ER Negative Early Stage Breast Cancer (PBI 3.0)
The purpose of this study is to determine whether giving partial breast irradiation and chemotherapy at the same time has the same side effects and outcomes as giving partial breast irradiation and chemotherapy at different times.
Women with ER negative breast cancer have a higher risk of the cancer returning in the breast after whole or partial breast radiation than women with ER positive breast cancer. In a small study at Johns Hopkins, women were treated with partial breast irradiation and chemotherapy given at the same time. This combined treatment was safe and women with ER negative breast cancer did just as well as women with ER positive cancer. We are now testing in a bigger study whether giving partial breast irradiation and chemotherapy at the same time (our new method) has the same side effects and outcomes as giving partial breast irradiation and chemotherapy at different times(older method). In this study women who had their breast cancer removed but need radiation to the breast will be randomized to partial breast irradiation at the same time as chemotherapy or partial breast radiation at a different time than chemotherapy. Randomization is like flipping a coin but in this study about 2 of every 3 women will get the new method.
- IRB Number: 1505594326 (J13104)
- Research Study Identifier: TX5321
- Principal Investigator: Richard Zellars, MD
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