Local Treatment by Thermic Destruction of Primitive Breast Cancer (LASERBREAST1)

Gustave Roussy

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01706016

2011/1773 (Other Identifier)

2012-A00448-35

Details and patient eligibility

About

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

Enrollment: 16 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Patients with breast cancer smaller than 20mm

Experimental group

Treatment:

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