BrUOG 291: Five Fraction Partial Breast Irradiation Using Non-invasive Image-guided Breast Brachytherapy (NIBB)

BrUOG 291: FIVE FRACTION PARTIAL BREAST IRRADIATION USING NON-INVASIVE IMAGE-GUIDED BREAST BRACHYTHERAPY (NIBB)

To evaluate safety of 5 fraction accelerated partial brest irradiation in more convenient 5 fraction schedule.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Device: Accuboost APBI

Detailed Description

The purpose of this study is to evaluate the rate of early and intermediate toxicity related to accelerated partial breast irradiation (APBI) delivered in a more convenient 5 fraction schedule using non-invasive image-guided breast brachytherapy (NIBB) (AccuBoost System) in women with resected, early stage breast cancer.

Non-invasive image-guided breast brachytherapy (NIBB), using advanced image-guided radiation technology, has the potential to eliminate the disadvantages of the conventional APBI techniques. NIBB facilitates non-invasive partial breast irradiation without the use of catheters or implants. Yet by using breast immobilization and precise image-guidance, it reduces non-target breast tissue within the irradiated field compared with other non-invasive APBI techniques such as 3D-CRT. This has made NIBB an attractive approach to deliver APBI.

We hypothesize that NIBB delivered in 5 treatments will be a more convenient, safe and effective modality to deliver partial breast irradiation.

Anticipated advantages of NIBB protocol treatment include:

• Convenient treatment schedule
• Short course can allow for increased patient access to treatment
• Non-invasive approach
• Increased accuracy with precise targeting of lumpectomy cavity using advanced imaging
• Reduced irradiation of non-target breast tissue
• Reduced skin toxicity
• No heart or lung radiation exposure
• Reduced late skin or breast toxicity
• High rate of good or excellent cosmetic outcome
• High rate of ipsilateral breast tumor control comparable to other APBI techniques

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

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093
      • UCSD Moores Cancer Center
  • Florida
    • Lakeland, Florida, United States, 33805
      • Watson Cancer Center
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital

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

5. Pathologic lymph node negative, which includes (pN0 i-, i+);

   Patients, who are at very low risk for sentinel node involvement and sentinel node biopsy is not performed, are eligible if the treating investigator documents clinically lymph node negative (cN0). These patients include:

   • DCIS
   • Microinvasion only
   • Pure tubular or mucinous histology
   • Patients ≥ 70yo with T1a-T1c; estrogen receptor +

6. Pathologic tumor size

   1. less than or equal to 2 cm for invasive disease;
   2. less than or equal to 3 cm for DCIS;
7. Estrogen receptor positive if invasive disease (DCIS can be ER negative)
8. Negative surgical margins greater than or equal to 2 mm. A margin of <2mm is acceptable if at natural boundary, i.e. skin or pectoralis fascia.
9. No lymphovascular invasion;
10. ECOG performance status of 0-2 (Appendix 1);
11. Informed consent signed.

Exclusion Criteria:

1. Known BRCA 1/2 Mutation; (BRCA 1 and 2 testing is not required)
2. Active lupus or scleraderma;
3. Pregnancy;
4. Psychiatric or addictive disorder that would preclude attending follow-up;
5. Neoadjuvant chemotherapy (adjuvant chemotherapy is permitted);
6. Suspicious remaining microcalcification on post-surgery mammogram (unless biopsy proven benign);
7. pN+ on axillary dissection or in the sentinel lymph node biopsy (N0i+ are considered node negative and are not excluded);
8. Multicentric disease;
9. Paget's disease of the nipple;
10. Breast Implants
11. Distant metastases;
12. Lumpectomy cavity not well visualized on AccuBoost imaging;
13. Lumpectomy cavity with 1cm margin (CTV/PTV) not adequately encompassed by any available applicator.
14. Breast separation with compression > 8cm at time of simulation.

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: Accuboost APBI; 28Gy delivered in 5 daily fractions	Device: Accuboost APBI; 28Gy delivered in 5 daily fractions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients With Any Toxicity Related to the Radiation Treatment	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.	during treatment, 2 and 6 weeks post treatment and then every 6 months for up to 2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Ipsilateral Breast Local Recurrence	annually for 2 years post treatment

Collaborators and Investigators

• Sponsor: Brown University
• Collaborators: University of California, San Diego; Cancer Treatment Centers of America; Watson cancer center
• Investigators: Principal Investigator: Jaroslaw Hepel, M.D., Brown University

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2014
• Primary Completion (Actual): October 26, 2016
• Study Completion (Actual): November 30, 2021

Study Registration Dates

• First Submitted: October 10, 2013
• First Submitted That Met QC Criteria: October 10, 2013
• First Posted (Estimate): October 11, 2013

Study Record Updates

• Last Update Posted (Actual): March 4, 2022
• Last Update Submitted That Met QC Criteria: February 23, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Invasive breast carcinoma; DCIS; IDC
• Other Study ID Numbers: 291