BrUOG 351: PRE-OPERATIVE APBI USING NIBB (351)

BrUOG 351: Pre-Operative Accelerated Partial Breast Irradiation (APBI) Using Non-Invasive Image-Guided Breast Brachytherapy (NIBB)

Partial breast irradiation is typically performed after surgical removal of the tumor. Partial breast irradiation allows for focused radiation to the area from which the cancer was removed, sparing breast tissue from the potential bad effects of radiation compared to radiating the whole breast, which was the standard of care for many years. This study is evaluating the use of partial breast irradiation with NIBB performed before surgery instead of after surgery.This should allow researchers to target the cancer even more accurately and result in less normal breast tissue receiving radiation which may cause less side effects and/or a better cosmetic outcome.

In this study partial breast treatment will be given with NIBB in 5 treatments over about 1 week. Surgical removal of the tumor will then be performed between 4-12 weeks following radiation treatment. Researchers believe that participant's risk of complications from surgery will not be higher after getting these radiation treatments than it would have been if participants had surgery first, but that is one of the things researchers are studying.

Study Overview

• Status: Withdrawn
• Conditions: Breast Cancer; Invasive Breast Cancer; Ductal Carcinoma in Situ
• Intervention / Treatment: Radiation: NIBB: accuboost; Procedure: Partial mastectomy

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Confirmed histological diagnosis of invasive breast carcinoma and/or DCIS (Invasive lobular carcinoma excluded);
• Age greater or equal to 60 years old;
• Life expectancy > 6 months;
• Candidate for breast conserving surgery who intends to undergo breast conserving surgery as confirmed in writing by treating physician in consultation with surgeon
• Clinically lymph node negative (cN0) as confirmed in writing by patient's treating physician. If patient has suspicious lymphadenopathy on imaging it is required that patient undergo a biopsy to confirm cN0.
• Tumor size by imaging ≤ 2cm; (Tis or T1)
• Estrogen receptor positive if invasive disease (DCIS can be ER negative);
• Her2neu negative if invasive disease;
• Nuclear Grade 1 or 2 if invasive disease (DCIS can be Grade 3);
• ECOG performance status of 0-2 (Appendix 1);
• Informed consent signed.

Exclusion Criteria:

• Excisional biopsy or ipsilateral breast surgery within 6 months;
• Invasive lobular histology;
• Definitive LVSI on biopsy;
• Suspicious imaging findings suggesting multi-focal or multi-centric disease, unless biopsy proven benign;
• Paget's disease of the nipple
• Distant metastases;
• Known BRCA 1/2 Mutation
• Active lupus or scleroderma,;
• Psychiatric or addictive disorder that would preclude attending follow-up;
• Neoadjuvant chemotherapy or endocrine therapy (adjuvant therapy is permitted);
• Breast Implants;
• Tumor not well visualized on AccuBoost imaging;
• 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: Treatment Arm; 28.5 Gy delivered in 5 daily fractions then 4-12 weeks post NIBB, surgery via partial mastectomy	Radiation: NIBB: accuboost; 28.5 Gy delivered in 5 daily fractions; Procedure: Partial mastectomy; 4-12 weeks post NIBB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of APBI including rate of surgical complications.		Surgery will occur 4-12 weeks post NIBB treatment
Toxicity of pre-op APBI including rate of surgical complications.	Defined as acute (during treatment and through 4 weeks post treatment)	Defined at up to 6 weeks post APBI
Toxicity of surgical complications		Surgery to occur 4-12 weeks post radiation and post-op complications collected through 3 months post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess and report late toxicity	Late toxicity defined as 6 weeks post NIBB through 3 years in follow-up	6 weeks post treatment through 3 years

Collaborators and Investigators

• Sponsor: Jaroslaw Hepel
• Collaborators: Brown University; Rhode Island Hospital; Women and Infants Hospital of Rhode Island
• Investigators: Principal Investigator: Jaroslaw Hepel, MD, Rhode Island Hospital/ BrUOG

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2019
• Primary Completion (Actual): January 21, 2020
• Study Completion (Actual): January 21, 2020

Study Registration Dates

• First Submitted: February 9, 2018
• First Submitted That Met QC Criteria: February 15, 2018
• First Posted (Actual): February 19, 2018

Study Record Updates

• Last Update Posted (Actual): March 9, 2021
• Last Update Submitted That Met QC Criteria: March 5, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Breast Diseases; Neoplasms, Ductal, Lobular, and Medullary; Breast Carcinoma In Situ; Carcinoma in Situ; Breast Neoplasms; Carcinoma, Ductal; Carcinoma, Intraductal, Noninfiltrating
• Other Study ID Numbers: BrUOG 351

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No