Breast-Conserving Surgery Techniques in Treating Women With Breast Cancer
Conditions
Breast Cancer
Conditions: official terms
Breast Neoplasms
Conditions: Keywords
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
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Primary Purpose: Treatment
Intervention
Name: quality-of-life assessment Type: Procedure
Name: therapeutic conventional surgery Type: Procedure
Overall Status
Recruiting
Summary
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
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: 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
Location
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France
Status: Recruiting
Contact: Philippe Rouanet, MD, PhD - 04-67-61-3071 - prouanet@valdorel.fnclcc.fr
Start Date
April 2007
Sponsors
Institut du Cancer de Montpellier - Val d'Aurelle
Source
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page