Pilot Trial of Preop Partial Radiation in Breast Cancer Patients

NCT07178665 | Suspended Phase 1 DMC

• 1 other identifier: 152502
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 10

Brief 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

Early-stage Breast Cancer; Breast Carcinoma; DCIS

Outcome Measures

Primary Outcomes (1)

• Safety and feasibility of preoperative APBI

  Evaluate the rate of surgical wound complications (infection, delayed healing, dehiscence) following preoperative accelerated partial breast irradiation (APBI).

  Up to 30 days after surgery (with continued safety monitoring through 3 years).

Secondary Outcomes (1)

• Quality of life (QoL)

  At consultation, and selected follow-up visits up to 3 years.

Study Arms (1)

Preoperative Partial Breast Irradiation

EXPERIMENTAL

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).

Radiation: Radiation: Accelerated Partial Breast Irradiation (APBI)

Interventions

Radiation: Accelerated Partial Breast Irradiation (APBI) RADIATION

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.

Preoperative Partial Breast Irradiation

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Indication for neoadjuvant chemotherapy or hormone therapy Tumor size \>2cm clinically or radiographically ER- on biopsy G3 invasive cancer or DCIS on biopsy Lobular histology Multicentric/multifocal tumor BRCA+ gene mutation Prior ipsilateral breast or thoracic RT Contraindication for baseline MRI Contraindication for surgery Distant metastatic disease Other synchronous cancer (besides bilateral breast) Contraindication to Radiation therapy (presence of scleroderma or other collagen vascular disease) Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (10)

RWJBarnabas Health Clara Maas Medical Center

Belleville, New Jersey, 07109, United States

Location

Trinitas Hospital and Comprehensive Cancer Center

Elizabeth, New Jersey, 07202, United States

Location

RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton

Hamilton, New Jersey, 08690, United States

Location

RWJBarnabas Health Jersey City Medical Center

Jersey City, New Jersey, 07302, United States

Location

Cooperman Barnabas Medical Center

Livingston, New Jersey, 07039, United States

Location

RWJBarnabas Health - Monmouth Medical Center

Long Branch, New Jersey, 07740, United States

Location

Jack and Sheryl Morris Cancer Center

New Brunswick, New Jersey, 08901, United States

Location

RWJBarnabas Health Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

Location

RWJBarnabas Health - Robert Wood Johnson University Hospital Somerset

Somerset, New Jersey, 08873, United States

Location

RWJBarnabas Health - Community Medical Center

Toms River, New Jersey, 08755, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Intraductal, Noninfiltrating

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Radiation Oncology, Rutgers Robert Wood Johnson Medical School

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 17, 2025
• Study Start: September 2, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: November 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)