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


Phase 2
18 Years
80 Years
Open (Enrolling)
Female
Breast Cancer

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Trial Information

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


Inclusion Criteria:



- Noninflammatory unilateral and unifocal breast cancer

- Size
- 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Effectiveness of laser treatment

Outcome Description:

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

Outcome Time Frame:

28 days after initial diagnosis

Safety Issue:

No

Principal Investigator

Jean Remy GARBAY, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gustave Roussy, Cancer Campus, Grand Paris

Authority:

France: Agence Nationale de Sécurité du Médicament et des produits de santé

Study ID:

2012-A00448-35

NCT ID:

NCT01706016

Start Date:

October 2012

Completion Date:

March 2014

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

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