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Preoperative Irradiation for Stage I Breast Cancer

NCT05464667 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-05-08

No results posted yet for this study

Summary

The novel use of preoperative RT will have broad implications for breast cancer patients, most of whom present with early-stage disease. In the era of reduced chemotherapy delivery, preoperative RT will allow oncologists to assess radiologic and biologic tumor response and correlate it to outcomes. Underutilization of RT negatively affects mortality. This trial aims to further evaluate pre-operative radiation therapy in patients with early stage, biologically favorable breast cancer, with improved access to RT.

Conditions

Interventions

RADIATION

Radiation Therapy (RT)

Dose Escalation: 4 Cohorts - 30 GY in 5 fractions (baseline treatment with 0 boost dose to GTV), 35, 40, 50 Gy in 5 fractions (Par 1) Dose Expansion: Maximum Tolerated Dose determined during dose escalation (Part 2)

Sponsors & Collaborators

  • Parul Barry

    lead OTHER

Principal Investigators

  • Parul Barry, MD · UPMC Hillman Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-07
Primary Completion
2026-01-09
Completion
2030-01-09
FDA Device
Yes

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 NCT05464667 on ClinicalTrials.gov