Breast-Conserving Surgery Techniques in Treating Women With Breast Cancer
RATIONALE: Breast-conserving surgery is a less invasive type of surgery for breast cancer and may have fewer side effects and improve recovery.
PURPOSE: This phase II trial is studying different breast-conserving surgery techniques in treating women with breast cancer.
|Breast Cancer||Procedure: quality-of-life assessment Procedure: therapeutic conventional surgery||Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Multicenter (Phase II) Study of Oncoplastic Surgical Techniques for Breast Conservation in Breast Cancers|
- Percentage of histologically healthy margins maintained during resection [ Time Frame: From inclusion to end of intervention ]
|Study Start Date:||April 2007|
|Study Completion Date:||December 2010|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
|Experimental: Surgerie||Procedure: quality-of-life assessment Procedure: therapeutic conventional surgery|
- Evaluate the percentage of histologically healthy margins maintained during resection in women with breast cancer.
- Evaluate local recurrence at 5 years.
- Evaluate aesthetic results.
- Evaluate quality of life using the QLQC30 and BR23 questionnaires.
OUTLINE: This is a multicenter study.
Patients undergo oncoplastic conservative surgery according to defined modalities across the various centers.
Quality of life is assessed periodically.
After completion of study treatment, patients are followed every 6 months for 2 years and then for at least 3 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00870415
|Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle|
|Montpellier, France, 34298|
|Principal Investigator:||Philippe Rouanet, MD, PhD||Institut du Cancer de Montpellier - Val d'Aurelle|