Node Negative, Invasive Breast Cancer Single Fraction IOERT

Lumpectomy Followed by Intraoperative Electron Radiation Therapy (IOERT) as a Single Full Dose Partial Breast Irradiation for Early Stage, Node Negative, Invasive Breast Cancer

The purpose of this study is to determine if lumpectomy followed by Intraoperative Electron Radiation Therapy (IOeRT) as a single, full dose partial breast irradiation will have as good or better results in preventing recurrence of local breast cancer, cosmetic appearance and early and late side effects.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Radiation: Single Fraction IOeRT

Detailed Description

See points VIII inclusion/exclusion criteria

Operation:

• Lumpectomy, steninal node biopsy
• IOeRT

After Surgery:

• Meet with a medical oncologist and discuss if chemotherapy and/or hormone therapy is recommended as part of your treatment course. In some cases, pathology results may indicate the need for removal of additional lymph nodes. The doctor will review pathology and discuss if additional surgery is required.
• Chemotherapy (if indicated)
• Hormone therapy (if indicated)

Follow-Up

• Visits will be completed with the surgeon, radiation oncologist and research staff as the protocol indicates.
• Assessements of acute toxicity according to CTC-toxicity scoring system
• Assessments of late toxicity according to LENT-SOMA scoring systems
• Assessment of cosmetic outcome according to scoring system and photo documentation in standardized positions.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Avera Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient agrees to breast conservation therapy (segmental resection, partial mastectomy, and radiation therapy) as the treatment for their breast cancer
• Patient agrees to evaluation of the axilla with sentinel lymph node biopsy
• Post-menopausal women age > 60, defined as women who have experienced no menstrual period in the past 12 months.
• BRCA1 and 2 gene mutation negative, if tested. [genetic testing is NOT required based upon personal or family history]
• Unifocal (unicentric), invasive ductal carcinoma or favorable sub-types (mucinous, tubular, colloid) < 2.0 cm in diameter, primary T-stage of T1 (AJCC criteria)
• Grade 1, 2 acceptable
• Associated LCIS is allowed
• Estrogen receptor (ER) status of positive
• Negative margins at ink on gross pathologic examination
• Patient is node-negative, defined as N0 (i-) or N0 (i+)
• Patient must be deemed functionally and mentally competent to understand and sign the informed consent

Exclusion Criteria:

• Prior breast malignancy or other malignancy if metastatic, or with expected survival of < 5 years
• Immuno-compromised status
• Pregnancy
• Women with an active connective tissue disorder (i.e. scleroderma, lupus and others)
• Breast cancer that involves the skin or chest wall, locally advanced breast cancer
• Pure DCIS, all grades
• Invasive lobular carcinoma
• Evidence of lymphovascular invasion (LVI)
• Invasive carcinoma with extensive intraductal component (EIC)
• Neoadjuvant chemotherapy indicated
• Patients with 1 or more positive lymph node determined during surgery with sentinel node and/or axillary dissection
• Not eligible for breast conserving management, i.e., prior whole breast radiation therapy
• Estrogen receptor negative
• Her2 positive
• Grade 3

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Fraction IOeRT; A single dose of 21 Gy calculated such that the 90% isodose line encompasses the posterior of the tumor bed will be administered.	Radiation: Single Fraction IOeRT; A single dose of 21 Gy calculated such that the 90% isodose line encompasses the posterior of the tumor bed will be administered.; Other Names: Intra-Operative electron radiation therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients who are free of breast cancer.	Patients will be followed by standard of care breast imaging along with appointments with breast surgeon, radiation oncologist and medical oncologist if indicated.	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local recurrance rate with acute toxicity and cosmetic evaluations	AEs and Lent Soma will be assessed for acute toxicity. We will use a 20% toxicity cutoff, the protocol would be stopped if 2/10 were determined to have developed significant toxicities, grade 3 or greater, at the first 6-month follow-up visit. 2/10 patients at 6-months follow-up, 4/20 patients at 1-year follow-up, 6/30 at 18-months follow-up, 8/40 at 24-months follow-up, 10/50 at 30-months follow-up, 12/60 at 36-months follow-up, 14/70 at 42-months follow-up, 16/80 at 48-months follow-up, 18/90 at 54-months and 20/100 at 60-months follow-up. Cosmetic evaluations will be completed by the patient and radiation oncologist an via breast exams, questionnaires and breast photo documentation.	10 years

Collaborators and Investigators

• Sponsor: Avera McKennan Hospital & University Health Center
• Investigators: Principal Investigator: Kyle Arneson, MD, Avera Cancer Insitute

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): May 1, 2029

Study Registration Dates

• First Submitted: February 3, 2015
• First Submitted That Met QC Criteria: February 19, 2015
• First Posted (Estimated): February 25, 2015

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Radiation therapy; Radiation; Lumpectomy; IOERT; Single fraction; Avera
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: ACI-1450-IOERTSFX

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No