Breast-Conserving Surgery Techniques in Treating Women With Breast Cancer

I

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)

263 participants in 1 patient group

Surgerie
Experimental group
Treatment:
Procedure: therapeutic conventional surgery
Procedure: quality-of-life assessment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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