Breast CancerPhase 2LASERBREAST1NCT01706016
Local Treatment by Thermic Destruction of Primitive Breast Cancer
A Phase 2 study testing Thermic destruction of tissue by Laser using the Novilase device in people with Breast Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 3 sites in France.
Trial summary
Demonstrate the effectiveness of laser in the treatment of cancerous lesions by determinating with histological analysis of the specimen the percentage of tumor cells remaining in the area treated by the laser Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Thermic destruction of tissue by Laser using the Novilase device
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 3 sitesFrance
- Study dates
- 9 Oct 2012to 17 Nov 2016
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Noninflammatory unilateral and unifocal breast cancer
- Size </= 20mm (ultrasound measure)
- Histological confirmation of cancer by biopsy grade status hormone and HER2.
- Good delineation of the lesion on ultrasound.
- Minimum distance of 5 mm between the tumor and the skin between the tumor and muscle.
- Age between 18 and 80
- ECOG performance status 0 or 1
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
France3 sites
Centre Oscar Lambret
Lille, Nord, 59000
Hopital Lariboisière
Paris, 75010
Institut Gustave Roussy
Villejuif, Val De Marne, 94805
About this study
Official title: Local Treatment by Thermic Destruction of Primitive Breast Cancer. Phase II: Feasibility and Effectiveness, Standardization of Procedures.
Demonstrate the effectiveness of laser in the treatment of cancerous lesions by determinating with histological analysis of the specimen the percentage of tumor cells remaining in the area treated by the laser
- Conditions
- Breast Cancer
- Being tested
- Thermic destruction of tissue by Laser using the Novilase device
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermic destruction of tissue by Laser using the Novilase deviceProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients with breast cancer smaller than 20mm | Experimental | Not described Receives: Procedure: Thermic destruction of tissue by Laser using the Novilase device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of laser treatment
Destruction of the carcinoma will be assess by histological analysis of the specimen.
If more than 10% of viables cancerous cells are remaining in the volume treated by laser, the procedure would be a fail
Measured: 28 days after initial diagnosis
Secondary outcomes (1)
Life quality
Life quality will be assess using the questionnaire QLQ-C30 breast module BR23-version 3
Measured: D-0 and before the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2012 (estimated)
- Study start9 Oct 2012
- Primary completion17 Nov 2016
- Study completion17 Nov 2016
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 Gustave Roussy, Cancer Campus, Grand ParisThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Remy GARBAY, MD, Principal investigator, Gustave Roussy, Cancer Campus, Grand Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01706016
- Sponsor's protocol ID
- 2012-A00448-35
- Other IDs
- 2011/1773
- Acronym
- LASERBREAST1
- Status last verified
- Mar 2018
- First submitted
- 10 Oct 2012
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Treatment by Thermic Destruction of Primitive Breast Cancer. Phase II: Feasibility and Effectiveness, Standardization of Procedures.
- ClinicalTrials.gov ID
- NCT01706016
- Acronym / sponsor ID
- LASERBREAST1 / 2012-A00448-35
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- 9 Oct 2012 (actual)
- Primary completion
- 17 Nov 2016 (actual)
- Study completion
- 17 Nov 2016 (actual)
- First posted
- 15 Oct 2012 (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.
Demonstrate the effectiveness of laser in the treatment of cancerous lesions by determinating with histological analysis of the specimen the percentage of tumor cells remaining in the area treated by the laser
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with breast cancer smaller than 20mm | Experimental | Procedure: Thermic destruction of tissue by Laser using the Novilase device |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Noninflammatory unilateral and unifocal breast cancer
- Size </= 20mm (ultrasound measure)
- Histological confirmation of cancer by biopsy grade status hormone and HER2.
- Good delineation of the lesion on ultrasound.
- Minimum distance of 5 mm between the tumor and the skin between the tumor and muscle.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Thermic destruction of tissue by Laser using the Novilase device | Procedure or surgery | Patients with breast cancer smaller than 20mm |
Primary outcome
Effectiveness of laser treatment
Time frame: 28 days after initial diagnosis
Destruction of the carcinoma will be assess by histological analysis of the specimen. If more than 10% of viables cancerous cells are remaining in the volume treated by laser, the procedure would be a fail
1 secondary outcome
Life quality
Time frame: D-0 and before the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
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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.
Jean Remy GARBAY, MD principal investigator
Gustave Roussy, Cancer Campus, Grand Paris
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Thermic destruction of tissue by Laser using the Novilase device in people with Breast Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 3 sites in France.
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 7 inclusion and 0 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: finished, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Effectiveness of laser treatment (time frame: 28 days after initial diagnosis). 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 29 Mar 2018.