Local Treatment by Thermic Destruction of Primitive Breast Cancer

Phase 2

Completed

• Conditions: Breast Cancer

• Registration Number: NCT01706016
• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-09
• Study First Submitted: 2012-10-10
• Study First Submitted QC: 2012-10-12
• Study First Posted: 2012-10-15
• Primary Completion: 2016-11-17
• Study Completion: 2016-11-17
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-27
• Last Update Posted: 2018-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 16

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Effectiveness of laser treatment	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

Secondary Outcome Measures

Name	Time	Method
Life quality	D-0 and before the surgery	Life quality will be assess using the questionnaire QLQ-C30 breast module BR23-version 3

Trial Locations

Locations (3)

Centre Oscar Lambret; 🇫🇷 Lille, Nord, France

Institut Gustave Roussy; 🇫🇷 Villejuif, Val De Marne, France

Hopital Lariboisière; 🇫🇷 Paris, France