Status:
SUSPENDED
Pilot Trial of Preop Partial Radiation in Breast Cancer Patients
Lead Sponsor:
Rutgers, The State University of New Jersey
Conditions:
Early-stage Breast Cancer
Breast Carcinoma
Eligibility:
FEMALE
50-90 years
Phase:
PHASE1
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 t...
Detailed Description
Our primary objective is to demonstrate that the incidence of grade 3 or more wound complications in patients with non-metastatic and clinically node negative breast cancer or DCIS who are eligible fo...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
September 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT07178665
Start Date
September 2 2025
End Date
June 1 2028
Last Update
November 14 2025
Active Locations (10)
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1
RWJBarnabas Health Clara Maas Medical Center
Belleville, New Jersey, United States, 07109
2
Trinitas Hospital and Comprehensive Cancer Center
Elizabeth, New Jersey, United States, 07202
3
RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton
Hamilton, New Jersey, United States, 08690
4
RWJBarnabas Health Jersey City Medical Center
Jersey City, New Jersey, United States, 07302