Local Treatment by Thermic Destruction of Primitive Breast Cancer

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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Centre Oscar Lambret, Lille, Nord, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thermic destruction of tissue by Laser using the Novilase device

Procedure

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Other

Registry information

Official study title

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

Acronym: LASERBREAST1

Important dates

Study start: 2012
Primary completion: 2016
Study completion: 2016
First posted: Oct 15, 2012
Registry last updated: Mar 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed