Breast-Conserving Surgery Techniques in Treating Women With Breast Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Primary Evaluate the percentage of histologically healthy margins maintained during resection in women with breast cancer. Secondary 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.

Official Title
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Multicenter (Phase II) Study of Oncoplastic Surgical Techniques for Breast Conservation in Breast Cancers

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: quality-of-life assessment
* Procedure: therapeutic conventional surgery


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Meets 1 of the following criteria: Diagnosis of intraductal breast cancer requiring a wide local resection Diagnosis of infiltrating ductal breast cancer within range Diagnosis of invasive breast cancer that has not responded well to neoadjuvant treatment No multicentric tumor No gigantomastia Hormone receptor status not specified PATIENT CHARACTERISTICS: Menopausal status not specified No patients subject to a measure of legal protection or unable to express consent No patients deprived of liberty by judicial or administrative decision or hospitalized without patient consent Not pregnant or nursing PRIOR CONCURRENT THERAPY: No prior radiotherapy to the diseased breast No prior adjuvant treatment No concurrent participation in another clinical research study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surgerie<br> | Procedure: quality-of-life assessment<br> <br> Procedure: therapeutic conventional surgery<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of histologically healthy margins maintained during resection |  | From inclusion to end of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIC breast cancer, ductal breast carcinoma, invasive ductal breast carcinoma