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Node Negative, Invasive Breast Cancer Single Fraction IOERT

Primary Purpose

Breast Cancer

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Single Fraction IOeRT
Sponsored by
Avera McKennan Hospital & University Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring IOERT, Radiation, Single fraction, Lumpectomy, Radiation therapy, Avera

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Avera Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Fraction IOeRT

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 3, 2015
Last Updated
July 18, 2023
Sponsor
Avera McKennan Hospital & University Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT02370797
Brief Title
Node Negative, Invasive Breast Cancer Single Fraction IOERT
Official Title
Lumpectomy Followed by Intraoperative Electron Radiation Therapy (IOERT) as a Single Full Dose Partial Breast Irradiation for Early Stage, Node Negative, Invasive Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 2015 (undefined)
Primary Completion Date
February 2029 (Anticipated)
Study Completion Date
May 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Avera McKennan Hospital & University Health Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
IOERT, Radiation, Single fraction, Lumpectomy, Radiation therapy, Avera

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single Fraction IOeRT
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
Single Fraction IOeRT
Other Intervention Name(s)
Intra-Operative electron radiation therapy
Intervention Description
A single dose of 21 Gy calculated such that the 90% isodose line encompasses the posterior of the tumor bed will be administered.
Primary Outcome Measure Information:
Title
Proportion of patients who are free of breast cancer.
Description
Patients will be followed by standard of care breast imaging along with appointments with breast surgeon, radiation oncologist and medical oncologist if indicated.
Time Frame
10 years
Secondary Outcome Measure Information:
Title
Local recurrance rate with acute toxicity and cosmetic evaluations
Description
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.
Time Frame
10 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyle Arneson, MD
Organizational Affiliation
Avera Cancer Insitute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Avera Cancer Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Node Negative, Invasive Breast Cancer Single Fraction IOERT

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