Brief Summary

The investigators propose a randomized controlled superiority trial of standard breast-conserving surgery (BCS) versus BCS with cavity shave margins (CSM). The main objectives of this trial will be to evaluate prospectively the impact of routine standardized CSM on margin status following primary surgery for early stage breast cancer (Stage 0 - II), on post-operative patient satisfaction and cosmetic outcomes, and on general intraoperative time and operative costs. A parallel group format will be implemented to compare this modified surgical therapy - BCS with CSM - with BCS alone, which is the current standard of care.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_2 breast-cancer

Timeline

Completed

Started Jun 2016

Geographic Reach

1 country

1 active site

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.5 years study duration

First Submitted

Initial submission to the registry

June 1, 2015

Completed

2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2015

Completed

1 year until next milestone

Study Start

First participant enrolled

June 13, 2016

Completed

3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2019

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2019

Completed

Last Updated

June 25, 2020

Status Verified

June 1, 2020

Enrollment Period

3.5 years

First QC Date

June 1, 2015

Last Update Submit

June 22, 2020

Conditions

Breast Cancer Cancer of Breast Cancer of the Breast

Outcome Measures

Primary Outcomes (3)

Proportion of patients with positive margins on pathological specimen analysis
Completion of surgery for all enrolled patients (approximately 60 months)
Patient perceptions of the surgery as measured by BREAST-Q questionnaire and novel 3-dimensional breast imaging
* The BREAST-Q questionnaire consists of 13 sections. * The sections ask the patient questions about how they feel about how their breast area looks, how they feel emotionally, any physical side effects, and sexual side effects. * Some of the sections ask the patients to answer a question on a scale of None of the Time (equals=1) to All of the Time (equals=5) * Some of the sections ask the patients to answer a question on a scale of Very Dissatisfied (equals=1) to Very Satisfied (equals=4)
6-12 months post-surgery or post-radiation therapy, whichever is later)
Compare intraoperative NIR fluorescence from goggle system with pathologic tissue exam results
Completion of surgery for all enrolled patients (approximately 60 months)

Secondary Outcomes (4)

Relationship between CSM and volume of tissue excised in association iwth post-operative aesthetic outcomes
6-12 months post-surgery or post-radiation therapy, whichever is later)
Cost-effectiveness of routine CSM in BCS as measured by operative time, specimen processing, and resource usage
Completion of surgery for all enrolled patients (approximately 60 months)
Disease status associated with cancer biomarkers
Completion of surgery for all enrolled patients (approximately 60 months)
Tumor characteristics associated with cancer biomarkers
Completion of surgery for all enrolled patients (approximately 60 months)

Study Arms (2)

BCS Arm (breast-conserving surgery - standard of care)

ACTIVE COMPARATOR

* Defined as partial mastectomy, lumpectomy, or local excisional biopsy with or without needle/wire localization * The ICG will be prepared per manufacturer instructions and diluted to allow for intravenous dosing up to 0.5 mg/kg (except for those patients with iodine or seafood allergies or in cases where the goggles are unavailable for use). * Following the BCS procedures, the surgeon or a study team member will don the goggles and state the NIR fluorescence margin information of the excised primary tumor specimen and of and CSM that are taken.

Procedure: Breast-conserving surgery (BCS)Behavioral: BREAST-Q QuestionnaireDevice: 3-D breast imagingOther: Indocyanine greenDevice: Intraoperative imaging deviceProcedure: Peripheral blood draw

CSM Arm (breast-conserving surgery with cavity shave margins)

EXPERIMENTAL

* Partial mastectomy, lumpectomy, or local excisional biopsy with or without needle/wire localization with the addition of additional tissue specimens from all 6 margins (anterior, posterior, superior, inferior, medial, lateral) of the wound cavity if possible. In cases where an additional margin would involve the skin at the anterior margin and/or the pectoral muscle at the posterior margin, only the 4 (or 5) remaining margins should be obtained * A margin thickness of 1 cm will be the defined goal to establish uniformity among different surgeons and allow for appropriate pathological evaluation * The ICG will be prepared per manufacturer instructions and diluted to allow for intravenous dosing up to 0.5 mg/kg (no iodine or seafood allergies). * Following the BCS procedures, the surgeon or a study team member will don the goggles and state the NIR fluorescence margin information of the excised primary tumor specimen and of any CSM that are taken.

Procedure: Breast-conserving surgery (BCS)Procedure: Cavity shave margins (CSM)Behavioral: BREAST-Q QuestionnaireDevice: 3-D breast imagingOther: Indocyanine greenDevice: Intraoperative imaging deviceProcedure: Peripheral blood draw