Partial Breast Irradiation Using Non Invasive Approach for Early Stage Breast Cancer

ACCELERATED PARTIAL BREAST IRRADIATION USING NON-INVASIVE IMAGE-GUIDED BREAST BRACHYTHERAPY (ACCUBOOST) FOR EARLY STAGE BREAST CANCERS: A TOXICITY ASSESSMENT

The purpose of this study is to evaluate the rate of early and intermediate toxicity related to the AccuBoost System for delivery of APBI in women with resected, early stage breast cancer.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Radiation: Accelerated partial breast irradiation; Other: Extended Follow up

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Lakeland, Florida, United States, 33805
      • Center For Cancer Care and Research- Watson Clinic
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Brown University Oncology Research Group
    • Providence, Rhode Island, United States, 02903
      • Lifespan Hospitals
  • Washington
    • Tacoma, Washington, United States, 98405-4250
      • Tacoma Radiation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. A confirmed histological diagnosis of invasive breast carcinoma or DCIS
2. Age greater or equal to 50 years old
3. Life expectancy > 6 months
4. Treated by breast conserving surgery with axillary node dissection or sentinel lymph node biopsy
5. Pathologic tumor size less than or equal to 2 cm
6. Invasive ductal, mucinous, tubular or colloid histology
7. Estrogen receptor positive for invasive carcinoma.
8. Unifocal/unicentric disease
9. Negative surgical margins greater than or equal to 2 mm
10. Pathologic lymph node negative
11. No evidence of lymphovascular invasion
12. ECOG performance status of 0 or 1 (Appendix 1)
13. Informed consent signed.

Exclusion Criteria:

1. Known BRCA 1/2 Mutation; (BRCA 1 and 2 testing is not required)
2. Autoimmune disorder
3. Pregnancy
4. Breast implants
5. Psychiatric or addictive disorder that would preclude attending follow-up
6. Neoadjuvant chemotherapy (adjuvant chemotherapy is permitted)
7. Suspicious remaining microcalcification on post-surgery mammogram (unless biopsy proven benign)
8. Lobular features on histology (pure or mixed) or sarcoma histology
9. Node positive on axillary dissection or in the sentinel lymph node biopsy;
10. Extensive in situ carcinoma (EIC)
11. Multicentric or multifocal disease
12. Paget's disease of the nipple
13. Distant metastases
14. Lumpectomy cavity not well visualized on AccuBoost imaging
15. Lumpectomy cavity with 1cm margin (PTV) not adequately encompassed by any applicator (PTV > 6cm)
16. Breast separation with compression > 7cm.
17. Overlap of skin between orthogonal treatment axes.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Radiation; AccuBoost APBI- 34.0 Gy in 10fx	Radiation: Accelerated partial breast irradiation; Accuboost APBI 34.0 Gy in 10 fractions
Experimental: Extended Follow up; This arm extends follow up at the Rhode Island Hospital location to 5 years. Annual mammograms and additional documentation is required to be submitted only if completed.	Other: Extended Follow up; This arm extends follow up at the Rhode Island Hospital location to 5 years. Annual mammograms and additional documentation is required to be submitted only if completed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early and Intermediate Toxicity	Any toxicity related to the radiation treatment will be scored and graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 (Appendix 4). Acute side effects are any side effects occurring within 3 months of treatment. Intermediate side effects are any side effects occurring between 3 months and 2 years. This is reported in the outcome table.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cosmetic Outcome	Cosmetic results will be evaluated at each follow-up visit by the treating radiation oncologist using the Harvard criteria inclusive of discomfort during treatment(Pain), Fatigue and Acute skin reaction. This is reported in the outcome table.	2 years

Collaborators and Investigators

• Sponsor: Jaroslaw Hepel
• Collaborators: The Miriam Hospital; Rhode Island Hospital
• Investigators: Principal Investigator: Jaroslaw Hepel, MD, Brown University

Publications and helpful links

General Publications

• Hepel JT, Leonard KL, Sha S, Graves TA, Wiggins DL, Mastras D, Pittier A; Brown University Oncology Research Group; Wazer DE. Phase 2 Trial of Accelerated Partial Breast Irradiation (APBI) Using Noninvasive Image Guided Breast Brachytherapy (NIBB). Int J Radiat Oncol Biol Phys. 2020 Dec 1;108(5):1143-1149. doi: 10.1016/j.ijrobp.2020.07.2312. Epub 2020 Jul 25.
• Hepel JT, Hiatt JR, Sha S, Leonard KL, Graves TA, Wiggins DL, Mastras D, Pittier A; Brown University Oncology Research Group; Wazer DE. The rationale, technique, and feasibility of partial breast irradiation using noninvasive image-guided breast brachytherapy. Brachytherapy. 2014 Sep-Oct;13(5):493-501. doi: 10.1016/j.brachy.2014.05.014. Epub 2014 Jul 3.

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): September 12, 2013
• Study Completion (Actual): April 6, 2021

Study Registration Dates

• First Submitted: July 21, 2011
• First Submitted That Met QC Criteria: October 31, 2011
• First Posted (Estimate): November 1, 2011

Study Record Updates

• Last Update Posted (Actual): May 19, 2021
• Last Update Submitted That Met QC Criteria: April 30, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: breast cancer; radiation; ER positive; colloid; invasive ductal cancer; tubular breast cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: BrUOG 251