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Pilot Trial of Preop Partial Radiation in Breast Cancer Patients

NCT07178665 · Status: SUSPENDED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2025-11-14

No results posted yet for this study

Summary

The purpose of our study is to assess the feasibility of preoperative partial breast (APBI) radiation in breast cancer patients. The primary outcome is the acute wound complication rate. We also aim to evaluate cosmetic outcomes and late toxicities as secondary objectives. Another goal is to examine the histopathology of tumors before and after radiation to assess the response and other immunologic and/or molecular changes to the tumor and its environment elicited by the radiation treatment. We hope that this will guide future trials that could change practice in specific patient subgroups.

Conditions

Interventions

RADIATION

Radiation: Accelerated Partial Breast Irradiation (APBI)

Radiation: Accelerated Partial Breast Irradiation (APBI) - 5 fractions delivered every other day before surgery. Procedure: Surgery - lumpectomy or mastectomy scheduled 1-3 weeks after RT; additional whole-breast/lymph node RT if indicated.

Sponsors & Collaborators

  • Rutgers, The State University of New Jersey

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
90 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-02
Primary Completion
2027-06-01
Completion
2028-06-01

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 NCT07178665 on ClinicalTrials.gov