BrUOG 351: PRE-OPERATIVE APBI USING NIBB

NCT ID: NCT03437915

Last Updated: 2021-03-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-31
• Study Completion Date: 2020-01-21

Brief Summary

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.

Conditions

Breast Cancer; Invasive Breast Cancer; Ductal Carcinoma in Situ

Study Design

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

Study Groups

Treatment Arm

28.5 Gy delivered in 5 daily fractions then 4-12 weeks post NIBB, surgery via partial mastectomy

Group Type: EXPERIMENTAL

NIBB: accuboost

Intervention Type: RADIATION

28.5 Gy delivered in 5 daily fractions

Partial mastectomy

Intervention Type: PROCEDURE

4-12 weeks post NIBB

Interventions

NIBB: accuboost

28.5 Gy delivered in 5 daily fractions

Intervention Type: RADIATION

Partial mastectomy

4-12 weeks post NIBB

Intervention Type: PROCEDURE

Eligibility Criteria

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.

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

Sponsors

Brown University

OTHER

Sponsor Role: collaborator

Rhode Island Hospital

OTHER

Sponsor Role: collaborator

Women and Infants Hospital of Rhode Island

OTHER

Sponsor Role: collaborator

Jaroslaw Hepel

OTHER

Sponsor Role: lead

Responsible Party

Jaroslaw Hepel

Principal Investigator: Sponsor-Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jaroslaw Hepel, MD

Role: PRINCIPAL_INVESTIGATOR

Rhode Island Hospital/ BrUOG

Other Identifiers

BrUOG 351

Identifier Type: -

Identifier Source: org_study_id