Local Treatment by Thermic Destruction of Primitive Breast Cancer

Breast Cancer Clinical Trial

— LASERBREAST1  

Official title:

Local Treatment by Thermic Destruction of Primitive Breast Cancer. Phase II: Feasibility and Effectiveness, Standardization of Procedures.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01706016
• Other study ID #: 2012-A00448-35
• Secondary ID: 2011/1773
• Status: Completed
• Phase: Phase 2
• First received: October 10, 2012
• Last updated: March 27, 2018
• Start date: October 9, 2012
• Est. completion date: November 17, 2016

Study information

• Verified date: March 2018
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 17, 2016
• Est. primary completion date: November 17, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• Thermic destruction of tissue by Laser using the Novilase device

Locations

Country	Name	City	State
France	Centre Oscar Lambret	Lille	Nord
France	Hopital Lariboisière	Paris
France	Institut Gustave Roussy	Villejuif	Val De Marne

Sponsors (1)

Lead Sponsor	Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	28 days after initial diagnosis
Secondary	Life quality	Life quality will be assess using the questionnaire QLQ-C30 breast module BR23-version 3	D-0 and before the surgery