A Pilot Prospective Trial to Assess the Feasibility of Preoperative Partial Breast Radiation in Breast Cancer Patients.
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 for BCS and treated with pre-operative partial breast irradiation (PBI) at 1 month is no worse than the rates in the current standard of care (6-20%).
- RWJBarnabas Health
- Community Medical Center
- Clara Maass Medical Center
- Cooperman Barnabas, Livingston
- Jersey City Medical Center, Jersey City
- Monmouth Medical Center
- Newark Beth Israel Medical Center
- Robert Wood Johnson University Hospital, Hamilton
- Robert Wood Johnson University Hospital, Somerset
- Trinitas Hospital and Comprehensive Cancer Center
- Rutgers University
Inclusion Criteria: 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 Criteria: 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.
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
For further information about clinical trials, please contact us at 732-235-7356.