Pilot Trial of Preop Partial Radiation in Breast Cancer Patients

Paused · Phase 1

Conditions studied: Early-stage Breast Cancer, Breast Carcinoma, DCIS

In brief

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.

Key facts

Study ID

NCT07178665

Run by

Rutgers, The State University of New Jersey

People needed

98

Starts

2025-09-02

Expected to finish

2028-06-01

Last updated by the study team

2025-11-14

Who can join

Age: 50 and older, up to 90. Sex: female. Healthy volunteers: not accepted.

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.

Where it is running

• RWJBarnabas Health Clara Maas Medical Center — Belleville, New Jersey, United States
• Trinitas Hospital and Comprehensive Cancer Center — Elizabeth, New Jersey, United States
• RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton — Hamilton, New Jersey, United States
• RWJBarnabas Health Jersey City Medical Center — Jersey City, New Jersey, United States
• Cooperman Barnabas Medical Center — Livingston, New Jersey, United States
• RWJBarnabas Health - Monmouth Medical Center — Long Branch, New Jersey, United States
• Jack and Sheryl Morris Cancer Center — New Brunswick, New Jersey, United States
• RWJBarnabas Health Newark Beth Israel Medical Center — Newark, New Jersey, United States
• RWJBarnabas Health - Robert Wood Johnson University Hospital Somerset — Somerset, New Jersey, United States
• RWJBarnabas Health - Community Medical Center — Toms River, New Jersey, United States

Full record on ClinicalTrials.gov

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