This trial is active, not recruiting.

Condition breast cancer
Treatment intraoperative radiotherapy
Sponsor Hoag Memorial Hospital Presbyterian
Start date June 2010
End date September 2013
Trial size 200 participants
Trial identifier NCT01189851, IORT


Up to 200 patients with biopsy proven early stage breast cancer selecting Wide Local Excision (WLE) will undergo mammography, ultrasound (of affected breast and ipsilateral axilla) and contrast enhanced-magnetic resonance imaging (CE-MRI) of the affected breast to evaluate the extent of disease.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Treated with Intraoperative Radiation Therapy
intraoperative radiotherapy 510(k) Number K050843
The Axxent eBx™ System utilizes a miniaturized high dose rate (HDR) X-ray source to apply radiation directly to the cancerous tumor bed and provides brachytherapy when the physician chooses to deliver intracavitary or interstitial radiation to the surgical margins following lumpectomy for breast cancer.

Primary Outcomes

Proportion of Participants Receiving Additional Surgery Because of Positive or Close Margins as a Measure of the Accuracy of Pre-Operative Assessment
time frame: 5 years

Secondary Outcomes

Proportion of Participants Recommended to Have Additional Whole Breast Radiation Therapy (WBRT) Because of High Risk Features Found on Final Pathology as a Measure of the Accuracy of Pre-Operative Assessment
time frame: 5 years
Proportion of Participants with Tumor Size Larger than the Entry Criteria Size and/or Positive Lymph Nodes as a Measure of the Accuracy of Pre-Operative Assessment
time frame: 5 years
Proportion of Participants with Serious Adverse Events and/or Complications as a Measure of the Safety of the Treatment Algorithm
time frame: 5 years
Cosmesis Scores by Physician and Self-Assessment
time frame: 5 years
Progression Free Survival in the First Five Years
time frame: 5 years

Eligibility Criteria

Female participants at least 48 years old.

Inclusion Criteria: 1. Informed Consent. Each eligible patient must willingly give written consent after being informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts. 2. Histology. Patients must have biopsy-proven invasive ductal or lobular carcinoma of the breast. 3. Female, age ≥ 48 years. 4. Clinically and/or histologically negative axillary lymph nodes. 5. No imaging or clinical findings that indicate metastatic disease. 6. Procedure deemed appropriate based upon factors such as breast size by the treating surgeon and radiation oncologist. Exclusion Criteria: 1. Male sex 2. Age < 48 3. Non-epithelial breast malignancies such as sarcoma, lymphoma, or metastatic breast cancer 4. Pregnancy or lactation 5. Serious psychiatric or addictive disorders 6. More than one obvious cancer in the same breast as diagnosed by clinical examination, mammography, ultrasonography, and/or CE-MRI. 7. Bilateral breast cancer at the time of diagnosis, unless agreed upon by the surgeon and radiation oncologist. 8. Ipsilateral breast with a previous cancer and/or irradiation. 9. Extensive Intraductal Component (DCIS ≥ 25% of the tumor). 10. Patients presenting with gross nodal disease considered to be clinically malignant by scanning or proven cytologically or by sentinel node biopsy will be cancelled. 11. Previous history of malignant disease does not preclude entry if the expectation of relapse-free survival at 10 years is 90% or greater. 12. Lymphovascular invasion on needle biopsy. 13. Patients undergoing primary medical treatment (hormones or chemotherapy) as initial treatment with intent to reduce tumor size.

Additional Information

Official title Intraoperative Radiotherapy (IORT) for the Management of Carcinoma of the Breast: Use of Mammography, Ultrasonography,and Contrast-Enhanced Magnetic Resonance Imaging (CE-MRI) to Identify Candidates for IORT
Principal investigator Peter V Chen, MD
Description Patients will be deemed eligible for immediate IORT if the invasive cancer lesion is estimated to measure ≤ 3.0 centimeters maximum dimension by mammogram, ultrasound, and CE-MRI and is thought to be resectable with WLE and clear surgical margins, with clinically staged N0M0 disease, minimum age of 48, and histology of invasive ductal or lobular carcinoma of the breast. The lesion size determined by imaging will be compared with lesion size and surgical margin status obtained from the surgical pathology specimen to evaluate the ability of mammography combined with ultrasound and CE-MRI to identify suitable candidates for immediate IORT.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Hoag Memorial Hospital Presbyterian.