BrUOG 351: PRE-OPERATIVE APBI USING NIBB

NCT03437915 | Withdrawn DMC

• 1 other identifier: BrUOG 351
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Assess and report late toxicity

  6 weeks post treatment through 3 years

Study Arms (1)

Treatment Arm

EXPERIMENTAL

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

Radiation: NIBB: accuboost; Procedure: Partial mastectomy

Interventions

NIBB: accuboost RADIATION

28.5 Gy delivered in 5 daily fractions

Treatment Arm

Partial mastectomy PROCEDURE

4-12 weeks post NIBB

Treatment Arm

Eligibility Criteria

• Age: 60 Years+
• Gender Eligibility Details: This study is specifically enrolling female patients with breast cancer age 60 or older.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jaroslaw Hepel: lead
• Brown University: collaborator
• Rhode Island Hospital: collaborator
• Women and Infants Hospital of Rhode Island: collaborator

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Intraductal, Noninfiltrating

Interventions

Mastectomy, Segmental

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Mastectomy; Surgical Procedures, Operative

Study Officials

• Jaroslaw Hepel, MD

  Rhode Island Hospital/ BrUOG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator: Sponsor-Investigator

Study Record Dates

• First Submitted: February 9, 2018
• First Posted: February 19, 2018
• Study Start: March 1, 2019
• Primary Completion: January 21, 2020
• Study Completion: January 21, 2020
• Last Updated: March 9, 2021

Record last verified: 2021-03