Breast CancerPhase 2SMARTNCT02462200
Shave Margins in Breast Conservation Therapy
A Phase 2 study testing Breast-conserving surgery (BCS), Cavity shave margins (CSM) and BREAST-Q Questionnaire in people with Breast Cancer and Cancer of Breast, run by Washington University School of Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Breast Cancer, Cancer of Breast, Cancer of the Breast
- What is being tested?
- Breast-conserving surgery (BCS), Cavity shave margins (CSM) and BREAST-Q Questionnaire
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2016to 27 Nov 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Shave Margins in Breast Conservation Therapy (SMART): A Randomized Controlled Trial
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.
- Conditions
- Breast Cancer, Cancer of Breast, Cancer of the Breast
- Being tested
- Breast-conserving surgery (BCS), Cavity shave margins (CSM), BREAST-Q Questionnaire, 3-D breast imaging, Indocyanine green
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast-conserving surgery (BCS)Procedure or surgery
Cavity shave margins (CSM)Procedure or surgery
BREAST-Q QuestionnaireBehavioural
3-D breast imagingDevice
Using a 3-D breast imaging camera Vectra 3-D XT
Indocyanine greenOther
Also called ICG
Intraoperative imaging deviceDevice
The goggle device is wearable, compact, and battery-operated, and it allows for hands-free operation by the wearer. The goggles provide functional information via a NIR light-emitting diode (LED) integrated within one of the eyepieces, which causes NIR fluorescence excitation of the molecular probes within the surgical field
Peripheral blood drawProcedure or surgery
-Time of surgery if coordinator is available
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Breast-conserving surgery (BCS); Behavioral: BREAST-Q Questionnaire; Device: 3-D breast imaging; Other: Indocyanine green; Device: Intraoperative imaging device; Procedure: 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. Receives: Procedure: Breast-conserving surgery (BCS); Procedure: Cavity shave margins (CSM); Behavioral: BREAST-Q Questionnaire; Device: 3-D breast imaging; Other: Indocyanine green; Device: Intraoperative imaging device; Procedure: Peripheral blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with positive margins on pathological specimen analysis
Measured: 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)
Measured: 6-12 months post-surgery or post-radiation therapy, whichever is later)
Compare intraoperative NIR fluorescence from goggle system with pathologic tissue exam results
Measured: 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
Measured: 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
Measured: Completion of surgery for all enrolled patients (approximately 60 months)
Disease status associated with cancer biomarkers
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.
Measured: Completion of surgery for all enrolled patients (approximately 60 months)
Tumor characteristics associated with cancer biomarkers
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.
Measured: Completion of surgery for all enrolled patients (approximately 60 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2015 (estimated)
- Study start13 Jun 2016
- Primary completion27 Nov 2019
- Study completion27 Nov 2019
Why it stopped: Insufficient funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie Margenthaler, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02462200
- Sponsor's protocol ID
- 201506053
- Acronym
- SMART
- Status last verified
- Jun 2020
- First submitted
- 1 Jun 2015
- Last updated
- 25 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shave Margins in Breast Conservation Therapy (SMART): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02462200
- Acronym / sponsor ID
- SMART / 201506053
- Conditions
- Breast Cancer, Cancer of Breast, Cancer of the Breast
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient funding
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 13 Jun 2016 (actual)
- Primary completion
- 27 Nov 2019 (actual)
- Study completion
- 27 Nov 2019 (actual)
- First posted
- 3 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BCS Arm (breast-conserving surgery - standard of care) | Active comparator | Procedure: Breast-conserving surgery (BCS), Behavioral: BREAST-Q Questionnaire, Device: 3-D breast imaging, Other: Indocyanine green, Device: Intraoperative imaging device, Procedure: 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) | Experimental | Procedure: Breast-conserving surgery (BCS), Procedure: Cavity shave margins (CSM), Behavioral: BREAST-Q Questionnaire, Device: 3-D breast imaging, Other: Indocyanine green, Device: Intraoperative imaging device, Procedure: 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- Prior surgical treatment for this diagnosis.
- Undergone neoadjuvant chemotherapy.
- History of prior chest radiation therapy.
- Known metastatic disease.
- Pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breast-conserving surgery (BCS) | Procedure or surgery | BCS Arm (breast-conserving surgery - standard of care), CSM Arm (breast-conserving surgery with cavity shave margins) |
| Cavity shave margins (CSM) | Procedure or surgery | CSM Arm (breast-conserving surgery with cavity shave margins) |
| BREAST-Q Questionnaire | Behavioural | BCS Arm (breast-conserving surgery - standard of care), CSM Arm (breast-conserving surgery with cavity shave margins) |
| 3-D breast imagingUsing a 3-D breast imaging camera Vectra 3-D XT | Device | BCS Arm (breast-conserving surgery - standard of care), CSM Arm (breast-conserving surgery with cavity shave margins) |
| Indocyanine greenAlso: ICG | Other | BCS Arm (breast-conserving surgery - standard of care), CSM Arm (breast-conserving surgery with cavity shave margins) |
| Intraoperative imaging deviceThe goggle device is wearable, compact, and battery-operated, and it allows for hands-free operation by the wearer. The goggles provide functional information via a NIR light-emitting diode (LED) integrated within one of the eyepieces, which causes NIR fluorescence excitation of the molecular probes within the surgical field | Device | BCS Arm (breast-conserving surgery - standard of care), CSM Arm (breast-conserving surgery with cavity shave margins) |
| Peripheral blood draw-Time of surgery if coordinator is available | Procedure or surgery | BCS Arm (breast-conserving surgery - standard of care), CSM Arm (breast-conserving surgery with cavity shave margins) |
Primary outcome
Proportion of patients with positive margins on pathological specimen analysis
Time frame: 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
Time frame: 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)
Compare intraoperative NIR fluorescence from goggle system with pathologic tissue exam results
Time frame: Completion of surgery for all enrolled patients (approximately 60 months)
4 secondary outcomes
Relationship between CSM and volume of tissue excised in association iwth post-operative aesthetic outcomes
Time frame: 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
Time frame: Completion of surgery for all enrolled patients (approximately 60 months)
Disease status associated with cancer biomarkers
Time frame: Completion of surgery for all enrolled patients (approximately 60 months)
Tumor characteristics associated with cancer biomarkers
Time frame: Completion of surgery for all enrolled patients (approximately 60 months)
Results and safety
The study was stopped early (reason given: Insufficient funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2020.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Margenthaler, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Breast-conserving surgery (BCS), Cavity shave margins (CSM) and BREAST-Q Questionnaire in people with Breast Cancer and Cancer of Breast, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Insufficient funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with positive margins on pathological specimen analysis (time frame: Completion of surgery for all enrolled patients (approximately 60 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2020.