Shave Margins in Breast Conservation Therapy

Phase 2

Terminated

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

• Registration Number: NCT02462200
• Lead Sponsor: Washington University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-01
• Study First Submitted QC: 2015-06-02
• Study First Posted: 2015-06-03
• Study Start: 2016-06-13
• Primary Completion: 2019-11-27
• Study Completion: 2019-11-27
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-22
• Last Update Posted: 2020-06-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 81

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BCS Arm (breast-conserving surgery - standard of care)	BREAST-Q Questionnaire	* 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.
BCS Arm (breast-conserving surgery - standard of care)	3-D breast imaging	* 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.
BCS Arm (breast-conserving surgery - standard of care)	Peripheral blood draw	* 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.
CSM Arm (breast-conserving surgery with cavity shave margins)	Indocyanine green	* 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.
BCS Arm (breast-conserving surgery - standard of care)	Breast-conserving surgery (BCS)	* 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.
CSM Arm (breast-conserving surgery with cavity shave margins)	Cavity shave margins (CSM)	* 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.
CSM Arm (breast-conserving surgery with cavity shave margins)	3-D breast imaging	* 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.
BCS Arm (breast-conserving surgery - standard of care)	Indocyanine green	* 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.
BCS Arm (breast-conserving surgery - standard of care)	Intraoperative imaging device	* 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.
CSM Arm (breast-conserving surgery with cavity shave margins)	Breast-conserving surgery (BCS)	* 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.
CSM Arm (breast-conserving surgery with cavity shave margins)	Intraoperative imaging device	* 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.
CSM Arm (breast-conserving surgery with cavity shave margins)	BREAST-Q Questionnaire	* 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.
CSM Arm (breast-conserving surgery with cavity shave margins)	Peripheral blood draw	* 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.

Primary Outcome Measures

Name	Time	Method
Compare intraoperative NIR fluorescence from goggle system with pathologic tissue exam results	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	6-12 months post-surgery or post-radiation therapy, whichever is later)	* 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)
Proportion of patients with positive margins on pathological specimen analysis	Completion of surgery for all enrolled patients (approximately 60 months)

Secondary Outcome Measures

Name	Time	Method
Tumor characteristics associated with cancer biomarkers	Completion of surgery for all enrolled patients (approximately 60 months)	The investigators plan to assess plasma and serum levels of several candidate biomarkers, including a phosphorylated form of the annexin A2 protein ("P-annexin A2"), in study patients by immunoblotting/ELISA. This biomarker evaluation in the context of tumor characteristics will provide new information in the clinical detection and diagnosis of malignancy. Successful validation of these biomarkers may lead to development of novel blood-based cancer diagnostic tests.
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)	The investigators plan to assess plasma and serum levels of several candidate biomarkers, including a phosphorylated form of the annexin A2 protein ("P-annexin A2"), in study patients by immunoblotting/ELISA. This biomarker evaluation in the context of disease status will provide new information in the clinical detection and diagnosis of malignancy. Successful validation of these biomarkers may lead to development of novel blood-based cancer diagnostic tests.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States