Clinical trial NCT02462200: Shave Margins in Breast Conservation Therapy
Official title: Shave Margins in Breast Conservation Therapy (SMART): A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Cancer
Cancer of Breast
Cancer of the Breast
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2015-06-03
Enrollment: 81
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients with positive margins on pathological specimen analysis
timeFrame: Completion of surgery for all enrolled patients (approximately 60 months)
measure: Patient perceptions of the surgery as measured by BREAST-Q questionnaire and novel 3-dimensional breast imaging
timeFrame: 6-12 months post-surgery or post-radiation therapy, whichever is later)
measure: Compare intraoperative NIR fluorescence from goggle system with pathologic tissue exam results
timeFrame: Completion of surgery for all enrolled patients (approximately 60 months)
Secondary outcomes:
measure: Relationship between CSM and volume of tissue excised in association iwth post-operative aesthetic outcomes
timeFrame: 6-12 months post-surgery or post-radiation therapy, whichever is later)
measure: Cost-effectiveness of routine CSM in BCS as measured by operative time, specimen processing, and resource usage
timeFrame: Completion of surgery for all enrolled patients (approximately 60 months)
measure: Disease status associated with cancer biomarkers
timeFrame: Completion of surgery for all enrolled patients (approximately 60 months)
measure: Tumor characteristics associated with cancer biomarkers
timeFrame: Completion of surgery for all enrolled patients (approximately 60 months)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Julie Margenthaler, M.D.
role: PRINCIPAL_INVESTIGATOR
References: