Local Treatment by Thermic Destruction of Primitive Breast Cancer (LASERBREAST1)
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ClinicalTrials.gov Identifier: NCT01706016 |
Recruitment Status :
Completed
First Posted : October 15, 2012
Last Update Posted : March 29, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer | Procedure: Thermic destruction of tissue by Laser using the Novilase device | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 16 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Local Treatment by Thermic Destruction of Primitive Breast Cancer. Phase II: Feasibility and Effectiveness, Standardization of Procedures. |
Actual Study Start Date : | October 9, 2012 |
Actual Primary Completion Date : | November 17, 2016 |
Actual Study Completion Date : | November 17, 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: Patients with breast cancer smaller than 20mm |
Procedure: Thermic destruction of tissue by Laser using the Novilase device |
- 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
- Life quality [ Time Frame: D-0 and before the surgery ]Life quality will be assess using the questionnaire QLQ-C30 breast module BR23-version 3

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01706016
France | |
Centre Oscar Lambret | |
Lille, Nord, France, 59000 | |
Institut Gustave Roussy | |
Villejuif, Val De Marne, France, 94805 | |
Hopital Lariboisière | |
Paris, France, 75010 |
Principal Investigator: | Jean Remy GARBAY, MD | Gustave Roussy, Cancer Campus, Grand Paris |
Responsible Party: | Gustave Roussy, Cancer Campus, Grand Paris |
ClinicalTrials.gov Identifier: | NCT01706016 |
Other Study ID Numbers: |
2012-A00448-35 2011/1773 ( Other Identifier: Institut Gustave Roussy ) |
First Posted: | October 15, 2012 Key Record Dates |
Last Update Posted: | March 29, 2018 |
Last Verified: | March 2018 |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |