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Partial Irradiation and Sequential vs. Concurrent Chemo Early Breast Cancer

NCT01928589 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2026-03-06

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Richard Zellars

    lead OTHER

Principal Investigators

  • Richard Zellars, MD · Indiana University School of Medicine, Indiana University Simon Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-16
Primary Completion
2023-12-12
Completion
2028-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01928589 on ClinicalTrials.gov