Clinical trial NCT01189851: Intraoperative Radiotherapy for Early Stage Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: breast
IORT
electronic brachytherapy
Lead sponsor: Hoag Memorial Hospital Presbyterian
Sponsor class: OTHER
First posted: 2010-08-27
Enrollment: 200
Sex: FEMALE
Minimum age (years): 48
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of Participants Receiving Additional Surgery Because of Positive or Close Margins as a Measure of the Accuracy of Pre-Operative Assessment
timeFrame: 10 years
Secondary outcomes:
measure: 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
timeFrame: 5 years
measure: 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
timeFrame: 5 years
measure: Proportion of Participants with Serious Adverse Events and/or Complications as a Measure of the Safety of the Treatment Algorithm
timeFrame: 5 years
measure: Cosmesis Scores by Physician and Self-Assessment
timeFrame: 5 years
measure: Progression Free Survival in the First Five Years
timeFrame: 5 years
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian - Cancer Center
state: California
Study officials:
affiliation: Hoag Memorial Hospital Presbyterian
name: Peter V Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: