Shave Margins in Breast Conservation Therapy (SMART)

The Washington University

Status and phase: Terminated; Phase 2

Conditions: Cancer of Breast; Breast Cancer; Cancer of the Breast

Treatments: Device: Intraoperative imaging device; Procedure: Breast-conserving surgery (BCS); Behavioral: BREAST-Q Questionnaire; Procedure: Cavity shave margins (CSM); Procedure: Peripheral blood draw; Other: Indocyanine green; Device: 3-D breast imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT02462200

201506053

Details and patient eligibility

About

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.

Enrollment: 81 patients

Sex: Female

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Newly diagnosed, biopsy-proven stage 0-II breast cancer.
• Planning to undergo breast-conserving surgery.
• At least 18 years of age and no more than 85 years of age.
• Female.
• Able to understand and willing to sign an IRB-approved written informed consent document.

Exclusion criteria

• Prior surgical treatment for this diagnosis.
• Undergone neoadjuvant chemotherapy.
• History of prior chest radiation therapy.
• Known metastatic disease.
• Pregnant.
• Preference for mastectomy instead of breast-conserving surgery.
• History of ipsilateral breast cancer.
• Goggle assessment substudy: Iodine or seafood allergies.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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81 participants in 2 patient groups

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

Active Comparator group

Description:

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.

Treatment:

Device: 3-D breast imaging

Other: Indocyanine green

Procedure: Peripheral blood draw

Behavioral: BREAST-Q Questionnaire

Procedure: Breast-conserving surgery (BCS)

Device: Intraoperative imaging device

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

Experimental group

Description:

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.

Treatment:

Device: 3-D breast imaging

Other: Indocyanine green

Procedure: Peripheral blood draw

Procedure: Cavity shave margins (CSM)

Behavioral: BREAST-Q Questionnaire

Procedure: Breast-conserving surgery (BCS)

Device: Intraoperative imaging device