Intraoperative Radiotherapy for Early Stage Breast Cancer

NCT01189851 | Completed

• 1 other identifier: IORT
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

breast; IORT; electronic brachytherapy

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants Receiving Additional Surgery Because of Positive or Close Margins as a Measure of the Accuracy of Pre-Operative Assessment

  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.

  10 years

Secondary Outcomes (5)

• 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

• 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

• Proportion of Participants with Serious Adverse Events and/or Complications as a Measure of the Safety of the Treatment Algorithm

  5 years

• Cosmesis Scores by Physician and Self-Assessment

  5 years

• Progression Free Survival in the First Five Years

  5 years

Study Arms (1)

IORT

OTHER

Treated with Intraoperative Radiation Therapy

Device: Intraoperative Radiotherapy

Interventions

Intraoperative Radiotherapy DEVICE

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.

Also known as: 510(k) Number K050843, Axxent™ Electronic Brachytherapy System

IORT

Eligibility Criteria

• Age: 48 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Histology. Patients must have biopsy-proven invasive ductal or lobular carcinoma of the breast.
• Female, age ≥ 48 years.
• Clinically and/or histologically negative axillary lymph nodes.
• No imaging or clinical findings that indicate metastatic disease.
• Procedure deemed appropriate based upon factors such as breast size by the treating surgeon and radiation oncologist.

You may not qualify if:

• Male sex
• Age \< 48
• Non-epithelial breast malignancies such as sarcoma, lymphoma, or metastatic breast cancer
• Pregnancy or lactation
• Serious psychiatric or addictive disorders
• More than one obvious cancer in the same breast as diagnosed by clinical examination, mammography, ultrasonography, and/or CE-MRI.
• Bilateral breast cancer at the time of diagnosis, unless agreed upon by the surgeon and radiation oncologist.
• Ipsilateral breast with a previous cancer and/or irradiation.
• Extensive Intraductal Component (DCIS ≥ 25% of the tumor).
• Patients presenting with gross nodal disease considered to be clinically malignant by scanning or proven cytologically or by sentinel node biopsy will be cancelled.
• Previous history of malignant disease does not preclude entry if the expectation of relapse-free survival at 10 years is 90% or greater.
• Lymphovascular invasion on needle biopsy.
• Patients undergoing primary medical treatment (hormones or chemotherapy) as initial treatment with intent to reduce tumor size.

Sponsors & Collaborators

• Hoag Memorial Hospital Presbyterian: lead

Study Sites (1)

Hoag Memorial Hospital Presbyterian - Cancer Center

Newport Beach, California, 92658, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Peter V Chen, MD

  Hoag Memorial Hospital Presbyterian

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2010
• First Posted: August 27, 2010
• Study Start: June 1, 2010
• Primary Completion: September 1, 2023
• Study Completion: December 1, 2023
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

US (1)