A Pilot Prospective Trial to Assess the Feasibility of Preoperative Partial Breast Radiation in Breast Cancer Patients

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 50
Maximum Age: 90
Healthy Volunteers: f
View:

• Breast cancer patients with biopsy-proven invasive ductal cancer or DCIS Tumor size ≤ 2cm clinically and radiographically Estrogen-receptor positive (ER+) on biopsy Grade 1 or 2 on biopsy Clinically and radiographically node-negative disease No indication of metastatic disease Age \>50 Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 Negative serum pregnancy test if applicable Willingness to participate in the clinical trial and adhere to the study protocol Ability to understand and consent to the study

Locations
United States
New Jersey
RWJBarnabas Health Clara Maas Medical Center
NOT_YET_RECRUITING
Belleville
Trinitas Hospital and Comprehensive Cancer Center
RECRUITING
Elizabeth
RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton
NOT_YET_RECRUITING
Hamilton
RWJBarnabas Health Jersey City Medical Center
NOT_YET_RECRUITING
Jersey City
Cooperman Barnabas Medical Center
NOT_YET_RECRUITING
Livingston
RWJBarnabas Health - Monmouth Medical Center
NOT_YET_RECRUITING
Long Branch
Jack and Sheryl Morris Cancer Center
RECRUITING
New Brunswick
RWJBarnabas Health Newark Beth Israel Medical Center
NOT_YET_RECRUITING
Newark
RWJBarnabas Health - Robert Wood Johnson University Hospital Somerset
NOT_YET_RECRUITING
Somerset
RWJBarnabas Health - Community Medical Center
NOT_YET_RECRUITING
Toms River
Contact Information
Primary
Nisha Ohri, MD
no150@cinj.rutgers.edu
732-235-5203
Backup
Christian Misdary
cm1344@cinj.rutgers.edu
732-735-3626
Time Frame
Start Date: 2025-09-02
Estimated Completion Date: 2028-06-01
Participants
Target number of participants: 98
Treatments
Experimental: Preoperative Partial Breast Irradiation
Patients will receive 5 fractions of accelerated partial breast irradiation (APBI) delivered before surgery. Surgery is scheduled 1-3 weeks after radiation. If surgical pathology indicates, additional whole-breast or lymph node radiation may be given postoperatively (3-8 weeks after surgery).
Related Therapeutic Areas
Sponsors
Leads: Rutgers, The State University of New Jersey

This content was sourced from clinicaltrials.gov