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

Who is this study for? Patients with Breast Cancer
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Other, Radiation
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: No
View:

• Ability to understand and the willingness to sign a written informed consent document.

Locations
United States
Washington, D.c.
Sibley Memorial Hospital
Active, not recruiting
Washington
Indiana
Parkview Regional Medical Center
Recruiting
Fort Wayne
Indiana University Health Hospital
Recruiting
Indianapolis
Indiana University Health Melvin and Bren Simon Comprehensive Cancer Center
Recruiting
Indianapolis
IU Health Arnett
Recruiting
Lafayette
Maryland
John Hopkins University
Active, not recruiting
Baltimore
Suburban Hospital
Active, not recruiting
Bethesda
Pennsylvania
Reading Hospital
Completed
West Reading
York Cancer Center
Recruiting
York
Texas
University of Texas-San Antonio
Recruiting
San Antonio
Contact Information
Primary
Nikki Barrow
nrbarrow@iu.edu
317-944-0260
Backup
Kathryn Lauer
KLauer@iuhealth.org
317-962-3172
Time Frame
Start Date: September 2013
Estimated Completion Date: January 2026
Participants
Target number of participants: 159
Treatments
Active Comparator: PBI
270 cGy (centigray) x 15
Experimental: PBI with chemotherapy
270 cGy (centigray) x 15 concurrent with chemotherapy of the treating medical oncologist's choice
Related Therapeutic Areas
Sponsors
Leads: Richard Zellars

This content was sourced from clinicaltrials.gov

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