Breast-Conserving Surgery Techniques in Treating Women With Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00870415|
Recruitment Status : Completed
First Posted : March 27, 2009
Last Update Posted : August 21, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Procedure: quality-of-life assessment Procedure: therapeutic conventional surgery||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||263 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicenter (Phase II) Study of Oncoplastic Surgical Techniques for Breast Conservation in Breast Cancers|
|Study Start Date :||April 2007|
|Actual Primary Completion Date :||April 2009|
|Actual Study Completion Date :||December 2010|
|Experimental: Surgerie||Procedure: quality-of-life assessment Procedure: therapeutic conventional surgery|
- Percentage of histologically healthy margins maintained during resection [ Time Frame: From inclusion to end of intervention ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|