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

Primary Purpose

Breast Cancer, Invasive Breast Cancer, Ductal Carcinoma in Situ

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

NIBB: accuboost

Partial mastectomy

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Arm

Arm Description

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

Outcomes

Primary Outcome Measures

Feasibility of APBI including rate of surgical complications.

Toxicity of pre-op APBI including rate of surgical complications.

Defined as acute (during treatment and through 4 weeks post treatment)

Toxicity of surgical complications

Secondary Outcome Measures

Assess and report late toxicity

Late toxicity defined as 6 weeks post NIBB through 3 years in follow-up

Full Information

NCT ID

NCT03437915

First Posted

February 9, 2018

Last Updated

March 5, 2021

Sponsor

Jaroslaw Hepel

Collaborators

Brown University, Rhode Island Hospital, Women and Infants Hospital of Rhode Island

1. Study Identification

Unique Protocol Identification Number

NCT03437915

Brief Title

BrUOG 351: PRE-OPERATIVE APBI USING NIBB

Acronym

351

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Withdrawn

Why Stopped

Secondary to medicare coverage determination

Study Start Date

March 2019 (Anticipated)

Primary Completion Date

January 21, 2020 (Actual)

Study Completion Date

January 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Jaroslaw Hepel

Collaborators

Brown University, Rhode Island Hospital, Women and Infants Hospital of Rhode Island

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Invasive Breast Cancer, Ductal Carcinoma in Situ

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment Arm

Arm Type

Experimental

Arm Description

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

Intervention Type

Radiation

Intervention Name(s)

NIBB: accuboost

Intervention Description

28.5 Gy delivered in 5 daily fractions

Intervention Type

Procedure

Intervention Name(s)

Partial mastectomy

Intervention Description

4-12 weeks post NIBB

Primary Outcome Measure Information:

Title

Feasibility of APBI including rate of surgical complications.

Time Frame

Surgery will occur 4-12 weeks post NIBB treatment

Title

Toxicity of pre-op APBI including rate of surgical complications.

Description

Defined as acute (during treatment and through 4 weeks post treatment)

Time Frame

Defined at up to 6 weeks post APBI

Title

Toxicity of surgical complications

Time Frame

Surgery to occur 4-12 weeks post radiation and post-op complications collected through 3 months post surgery

Secondary Outcome Measure Information:

Title

Assess and report late toxicity

Description

Late toxicity defined as 6 weeks post NIBB through 3 years in follow-up

Time Frame

6 weeks post treatment through 3 years

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

This study is specifically enrolling female patients with breast cancer age 60 or older.

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jaroslaw Hepel, MD

Organizational Affiliation

Rhode Island Hospital/ BrUOG

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

BrUOG 351: PRE-OPERATIVE APBI USING NIBB

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