Breast-Conserving Surgery Techniques in Treating Women With Breast Cancer

Institut du Cancer de Montpellier - Val d'Aurelle

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Procedure: quality-of-life assessment; Procedure: therapeutic conventional surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT00870415

CLCC-ID-RCB-2006-A00694-47

CLCC-VA-2006/32

CLCC-PHRC-OP-06

CDR0000633327

INCA-RECF0638

Details and patient eligibility

About

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.

Full 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.

Enrollment: 263 patients

Sex: Female

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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263 participants in 1 patient group

Surgerie

Experimental group

Treatment:

Procedure: therapeutic conventional surgery

Procedure: quality-of-life assessment