Node Negative, Invasive Breast Cancer Single Fraction IOERT

NCT ID: NCT02370797

Last Updated: 2025-01-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2029-05-31

Brief Summary

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.

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Single Fraction IOeRT

Intervention Type: RADIATION

A single dose of 21 Gy calculated such that the 90% isodose line encompasses the posterior of the tumor bed will be administered.

Interventions

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.

Intervention Type: RADIATION

Other Intervention Names

Intra-Operative electron radiation therapy

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Avera McKennan Hospital & University Health Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kyle Arneson, MD

Role: PRINCIPAL_INVESTIGATOR

Avera Cancer Insitute

Locations

Avera Cancer Institute

Sioux Falls, South Dakota, United States

Countries

United States

Other Identifiers

ACI-1450-IOERTSFX

Identifier Type: -

Identifier Source: org_study_id