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ACTIVE NOT RECRUITING
NCT01928589
NA

Partial Irradiation and Sequential vs. Concurrent Chemo Early Breast Cancer

Sponsor: Richard Zellars

View on ClinicalTrials.gov

Summary

In a small study at Johns Hopkins, women were treated with partial breast irradiation and chemotherapy given at the same time. 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.

Official title: Randomized Phase II Study of Partial Breast Irradiation and Sequential vs. Concurrent Chemotherapy in Women With Early Stage Breast Cancer (PBI 3.0)

Key Details

Gender

FEMALE

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

81

Start Date

2014-01-16

Completion Date

2028-12

Last Updated

2026-03-06

Healthy Volunteers

No

Interventions

OTHER

PBI with sequential chemotherapy

270 cGy x15

OTHER

PBI with concurrent chemotherapy

270 cGy x15 concurrent with chemotherapy of the treating medical oncologist's choice

Locations (10)

Sibley Memorial Hospital

Washington D.C., District of Columbia, United States

Parkview Regional Medical Center

Fort Wayne, Indiana, United States

Indiana University Health Hospital

Indianapolis, Indiana, United States

Indiana University Health Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, United States

IU Health Arnett

Lafayette, Indiana, United States

John Hopkins University

Baltimore, Maryland, United States

Suburban Hospital

Bethesda, Maryland, United States

Reading Hospital

West Reading, Pennsylvania, United States

York Cancer Center

York, Pennsylvania, United States

University of Texas-San Antonio

San Antonio, Texas, United States