Breast-Conserving Surgery Techniques in Treating Women With Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00870415
• Other study ID #: CDR0000633327
• Secondary ID: CLCC-PHRC-OP-06C
• Status: Completed
• Phase: Phase 2
• First received: March 26, 2009
• Last updated: August 16, 2017
• Start date: April 2007
• Est. completion date: December 2010

Study information

• Verified date: August 2017
• Source: Institut du Cancer de Montpellier - Val d'Aurelle
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 263
• Est. completion date: December 2010
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• quality-of-life assessment

• therapeutic conventional surgery

Locations

Country	Name	City	State
France	Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
Institut du Cancer de Montpellier - Val d'Aurelle

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of histologically healthy margins maintained during resection		From inclusion to end of intervention