Malignant Neoplasm of BreastNCT03463954
Confirmatory Clinical Evaluation of Novilase® Laser Therapy for Focal Destruction of Malignant Breast Tumors
A study testing Novilase Laser ablation in people with Malignant Neoplasm of Breast, run by Novian Health Inc. at 13 sites in 5 countries.
Trial summary
Prior to this confirmatory pivotal study, the multicenter Br-002 feasibility study was completed. 98% of tumors less than or equal to 15mm were completely ablated in one procedure.This study will evaluate Novilase for the focal destruction of malignant tumors of the breast that are less than or equal to 15 mm against… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Malignant Neoplasm of Breast
- What is being tested?
- Novilase Laser ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 13 sitesin 5 countries
- Study dates
- 9 Aug 2023to 30 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females, aged 18 years and older
- Able to give written informed consent herself
- Definitive pathologic diagnosis by needle core biopsy
- Unifocal malignant tumor (T1a-c, N0-1, M0) that does not exceed 15 mm in longest dimension and measures at least 5 mm away from the skin and chest wall, or can be moved at least 5 mm away from the skin and chest wall by injection of saline or local anesthetic
- No more than 10 mm of calcifications confined to the tumor on imaging
- Tumor is well visualized through ultrasound or x-ray mammography imaging and amenable to image-guidance therapy (i.e., a tumor which is well visualized through imaging can be identified from surrounding breast tissue and does not have margins obscured by other structures or artifacts on the images)
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- Tumor is well visualized on MRI
- Subject with mammographic appearance of overall dense parenchymal tissue may be included, as long as a clearly evident marker is present at tumor site
- Tumor with less than 25% intraductal component, as determined by core biopsy
- No clinically significant co-morbidities (e.g., chronic illnesses existing simultaneously with and usually independent of breast cancer) that affect life expectancy
- Subject weight limited to ≤300 lbs. or ≤136 kg
- Subject agrees to comply with standard of care radiation or adjuvant therapy as prescribed by physician
Who cannot join
- Subject younger than 18 years of age
- Pregnant or breast-feeding
- Tumor poorly visualized by ultrasound or x-ray mammography imaging
- Contraindications to administration of gadolinium-based contrast agent, including: prior allergic reaction to a gadolinium-based contrast agent, moderate to end-stage kidney disease, and/or acute or chronic severe renal insufficiency (Glomerular filtration rate (GFR) <30ml/min/1.73 sq. meters)
- Contraindications to MRI according to site guidelines (e.g., cardiac pacemaker, metallic implants)
- History of severe asthma
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- Tumor measuring greater than 15 mm in longest dimension
- Microcalcifications that extend beyond target tumor such that overall longest dimension of target tumor and calcifications is longer than 15 mm.
- Advanced stage breast cancer
- Tumors that are lobular neoplasm, metastatic carcinoma to breast, sarcoma, Phyllodes tumor, or Paget's disease
- Tumor with only DCIS with microinvasion
- Extensive intraductal component in lesion (i.e., >25%) as determined by core biopsy
- Subject who is known to be BRCA positive
- Tumor that is ER/PR/HER2 negative (TNBC)
- Inability to lie in prone or supine position for one hour
- Subject who is currently participating in another investigational treatment, device or drug study through follow up that would interfere with this trial
- Subject without a definitive HER2 test according to ASCO/CAP guidelines
Trial locations and contacts
13 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
13 sites in 5 countries
United States7 sites, 5 recruiting
- Withdrawn
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
- Recruiting
Buffalo General Medical Center
Buffalo, New York, 14203
Gabriel Rubio, Grubio@gppconline.com
Stuti Tambar, MD
- Withdrawn
City of Hope
Duarte, California, 91010
- Not yet recruiting
Summit Health
Florham Park, New Jersey, 07932
Michelle McKenzie, RN, 973-436-1755, mmackenzie@summithealth.com
Winnie Polen, DO
- Recruiting
UC San Diego Health
La Jolla, California, 92037
Haydee Ojeda-Fournier, MD
- Recruiting
Yale University
New Haven, Connecticut, 06511
Kristen DeFrancesco, 203-785-3852, kristin.defrancesco@yale.edu
John Lewin, MD
- Recruiting
Eisenhower Health
Rancho Mirage, California, 92270
Azadeh Elmi, MD
Switzerland2 sites, 1 recruiting
- Terminated
Breast Centre Zurich
Zurich, 8008
- Recruiting
University Hospital Zurich
Zurich, 8091
Heike Frauchiger-Heuer, MD
United Kingdom2 sites, 2 recruiting
- Recruiting
Charing Cross Hospital, Imperial College Healthcare NHS Trust
London
Lesley Honeyfield
Cherry Cocol
- Recruiting
Churchill Hospital, Oxford University Hospitals NHS Trust
Oxford
Vanessa Fenech
Pankaj Roy, MD
Germany1 site, 1 recruiting
- Recruiting
St. Elisabeth-Krankenhaus Köln-Hohenlind
Cologne, 50935
Claudia Schumacher, MD
Israel1 site, 1 recruiting
- Recruiting
Ichilov | Tel Aviv Sourasky Medical Center
Tel Aviv
Orit Golan, MD
About this study
Official title: Prospective, Multicenter Confirmatory Clinical Evaluation of Novilase® Interstitial Laser Therapy for the Focal Destruction of Malignant Breast Tumors ≤15 mm (BR-003)
Prior to this confirmatory pivotal study, the multicenter Br-002 feasibility study was completed. 98% of tumors less than or equal to 15mm were completely ablated in one procedure.This study will evaluate Novilase for the focal destruction of malignant tumors of the breast that are less than or equal to 15 mm against a performance goal for the standard of care, lumpectomy. The ASBrS' goal of less than 20% retreatment by 2020 was selected as a representative performance goal, i.e., 80.0%, and is consistent with published effectiveness rates for lumpectomy.
Read the detailed description
Subjects with biopsy-diagnosed malignant breast tumors less than or equal to 15 mm will be invited to participate. Subjects will receive a screening MRI and if eligible will then have laser ablation, followed by MRI and an excision at 4-6 weeks following the laser procedure. This study will be deemed successful if the lower limit of a 95% confidence interval for the proportion of patients who have complete tumor ablation with one Novilase laser ablation procedure at 4-6 weeks post-procedure is greater than the performance goal. Specifically, Novilase will have demonstrated success if the complete tumor ablation rate is greater than 87.85%.
- Conditions
- Malignant Neoplasm of Breast
- Being tested
- Novilase Laser ablation
- Keywords
- less than or equal to 15 mm
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novilase Laser ablationDevice
Image-guided, percutaneous laser ablation of breast tumors
| Study group | Role | What they receive |
|---|---|---|
| Novilase Laser Ablation and excision | Experimental | Eligible subject will receive image-guided laser ablation of a targeted malignant breast tumor. At 4-6 weeks following the ablation, she will receive a MRI and excision. Pathology and MRI will determine rate of complete ablation. Subject is expected to proceed with radiation and/or adjuvant therapy per standard of care. Receives: Device: Novilase Laser ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of target tumors completely ablated in one procedure
Efficacy: Rate of complete ablation by Novilase laser ablation
Measured: 4-6 weeks
Frequency of adverse events (categorized using the NCI Common Terminology for Adverse Events (CTCAE) v4.0 guidelines) post-laser ablation and post-surgery
Safety: frequency of AEs
Measured: 4-6 weeks
Secondary outcomes (3)
Patient reported rate of return to activities of daily living post-laser ablation and post-surgery
Rate of recovery
Measured: 4-6 weeks
Physician reported cosmetic satisfaction, utilizing the 4-point scoring system of breast cosmesis in protocol (e.g., excellent, good, fair, poor) post-laser ablation and post-surgery (4-6 weeks)
Post-procedure cosmetic satisfaction
Measured: 4-6 weeks
Health related quality of life outcome measures at three timepoints via EORTC QLQ-C30 & QLQ-BR23 questionnaire (baseline and 4-6 weeks post-laser ablation and post-surgery)
Health-related quality of life outcome measures
Measured: 4-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study start9 Aug 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Neoplasm of BreastStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novian Health Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Lewin, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03463954
- Sponsor's protocol ID
- BR-003
- Status last verified
- Oct 2025
- First submitted
- 23 Jan 2018
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter Confirmatory Clinical Evaluation of Novilase® Interstitial Laser Therapy for the Focal Destruction of Malignant Breast Tumors ≤15 mm (BR-003)
- ClinicalTrials.gov ID
- NCT03463954
- Acronym / sponsor ID
- BR-003
- Conditions
- Malignant Neoplasm of Breast
- Keywords
- less than or equal to 15 mm
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Novian Health Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Aug 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 13 Mar 2018 (actual)
- 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.
Prior to this confirmatory pivotal study, the multicenter Br-002 feasibility study was completed. 98% of tumors less than or equal to 15mm were completely ablated in one procedure.This study will evaluate Novilase for the focal destruction of malignant tumors of the breast that are less than or equal to 15 mm against a performance goal for the standard of care, lumpectomy. The ASBrS' goal of less than 20% retreatment by 2020 was selected as a representative performance goal, i.e., 80.0%, and is consistent with published effectiveness rates for lumpectomy.
Detailed description
Subjects with biopsy-diagnosed malignant breast tumors less than or equal to 15 mm will be invited to participate. Subjects will receive a screening MRI and if eligible will then have laser ablation, followed by MRI and an excision at 4-6 weeks following the laser procedure. This study will be deemed successful if the lower limit of a 95% confidence interval for the proportion of patients who have complete tumor ablation with one Novilase laser ablation procedure at 4-6 weeks post-procedure is greater than the performance goal. Specifically, Novilase will have demonstrated success if the complete tumor ablation rate is greater than 87.85%.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Novilase Laser Ablation and excision | Experimental | Device: Novilase Laser ablationEligible subject will receive image-guided laser ablation of a targeted malignant breast tumor. At 4-6 weeks following the ablation, she will receive a MRI and excision. Pathology and MRI will determine rate of complete ablation. Subject is expected to proceed with radiation and/or adjuvant therapy per standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Females, aged 18 years and older
- Able to give written informed consent herself
- Definitive pathologic diagnosis by needle core biopsy
- Unifocal malignant tumor (T1a-c, N0-1, M0) that does not exceed 15 mm in longest dimension and measures at least 5 mm away from the skin and chest wall, or can be moved at least 5 mm away from the skin and chest wall by injection of saline or local anesthetic
- No more than 10 mm of calcifications confined to the tumor on imaging
Key exclusion criteria (17 listed)
- Subject younger than 18 years of age
- Pregnant or breast-feeding
- Tumor poorly visualized by ultrasound or x-ray mammography imaging
- Contraindications to administration of gadolinium-based contrast agent, including: prior allergic reaction to a gadolinium-based contrast agent, moderate to end-stage kidney disease, and/or acute or chronic severe renal insufficiency (Glomerular filtration rate (GFR) <30ml/min/1.73 sq. meters)
- Contraindications to MRI according to site guidelines (e.g., cardiac pacemaker, metallic implants)
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 |
|---|---|---|
| Novilase Laser ablationImage-guided, percutaneous laser ablation of breast tumors | Device | Novilase Laser Ablation and excision |
Primary outcome
Percentage of target tumors completely ablated in one procedure
Time frame: 4-6 weeks
Efficacy: Rate of complete ablation by Novilase laser ablation
Frequency of adverse events (categorized using the NCI Common Terminology for Adverse Events (CTCAE) v4.0 guidelines) post-laser ablation and post-surgery
Time frame: 4-6 weeks
Safety: frequency of AEs
3 secondary outcomes
Patient reported rate of return to activities of daily living post-laser ablation and post-surgery
Time frame: 4-6 weeks
Physician reported cosmetic satisfaction, utilizing the 4-point scoring system of breast cosmesis in protocol (e.g., excellent, good, fair, poor) post-laser ablation and post-surgery (4-6 weeks)
Time frame: 4-6 weeks
Health related quality of life outcome measures at three timepoints via EORTC QLQ-C30 & QLQ-BR23 questionnaire (baseline and 4-6 weeks post-laser ablation and post-surgery)
Time frame: 4-6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- 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.
John Lewin, MD principal investigator
Yale University
13 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novilase Laser ablation in people with Malignant Neoplasm of Breast, run by Novian Health Inc. at 13 sites in 5 countries.
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 12 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Switzerland, United Kingdom, Germany, Israel. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eugene Bajorinas (3122667200, ebajorinas@novianhealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of target tumors completely ablated in one procedure (time frame: 4-6 weeks). The study lists 2 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 19 Feb 2026.