Intraoperative Radiotherapy for Early Stage Breast Cancer

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Device: Intraoperative Radiotherapy

• Registration Number: NCT01189851
• Lead Sponsor: Hoag Memorial Hospital Presbyterian

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.

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-21
• Study First Submitted QC: 2010-08-25
• Study First Posted: 2010-08-27
• Primary Completion: 2023-09
• Study Completion: 2023-12
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-09
• Last Update Posted: 2024-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IORT	Intraoperative Radiotherapy	Treated with Intraoperative Radiation Therapy

Primary Outcome Measures

Name	Time	Method
Proportion of Participants Receiving Additional Surgery Because of Positive or Close Margins as a Measure of the Accuracy of Pre-Operative Assessment	10 years	Invasive cancer margins \<1 mm and/or non-invasive cancer margins \< 2 mm are considered close or positive. Approximately 15% of patients treated with IORT have close or positive margins on pathologic assessment following IORT therapy and are recommended for additional therapy including re-excision, whole breast radiation or both.

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival in the First Five Years	5 years	We will follow progression free survival for 5 years
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	5 years	Patients treated with IORT that have high risk features on final pathologic exam, including close/positive margins, tumor size \>30 mm, positive lymph nodes and lympho-vascular invasion (LVI) are recommended for additional therapy including re-excision, whole breast radiation or both.
Proportion of Participants with Serious Adverse Events and/or Complications as a Measure of the Safety of the Treatment Algorithm	5 years	We will be monitoring acute side effects attributed directly to IORT. These includ erythemia, hyperpigmentation, fibrosis, seromas, infection and wound breakdown.
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	5 years	Both tumor size and lymph node status are estimated prior to surgery using mammography, ultrasound and MRI (unless excluded for medical reasons). Patients with estimated tumor spans \> 30 mm or positive lymph nodes are excluded from IORT.
Cosmesis Scores by Physician and Self-Assessment	5 years	The first 213 IORT patients treated will be asked to fill out a yearly cosmesis assessment. Patients filled out these assessments for an average of 2-3 years.

Trial Locations

Locations (1)

Hoag Memorial Hospital Presbyterian - Cancer Center; 🇺🇸 Newport Beach, California, United States