Breast-Conserving Surgery Techniques in Treating Women With Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

263 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2010-12-31

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.

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Surgerie

Group Type EXPERIMENTAL

quality-of-life assessment

Intervention Type PROCEDURE

therapeutic conventional surgery

Intervention Type PROCEDURE

Interventions

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quality-of-life assessment

Intervention Type PROCEDURE

therapeutic conventional surgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No