We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Breast-Conserving Surgery Techniques in Treating Women With Breast Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00870415
First Posted: March 27, 2009
Last Update Posted: August 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Institut du Cancer de Montpellier - Val d'Aurelle
  Purpose

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.


Condition Intervention Phase
Breast Cancer Procedure: quality-of-life assessment Procedure: therapeutic conventional surgery Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter (Phase II) Study of Oncoplastic Surgical Techniques for Breast Conservation in Breast Cancers

Resource links provided by NLM:


Further study details as provided by Institut du Cancer de Montpellier - Val d'Aurelle:

Primary Outcome Measures:
  • Percentage of histologically healthy margins maintained during resection [ Time Frame: From inclusion to end of intervention ]

Enrollment: 263
Study Start Date: April 2007
Study Completion Date: December 2010
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Surgerie Procedure: quality-of-life assessment Procedure: therapeutic conventional surgery

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00870415


Locations
France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France, 34298
Sponsors and Collaborators
Institut du Cancer de Montpellier - Val d'Aurelle
Investigators
Principal Investigator: Philippe Rouanet, MD, PhD Institut du Cancer de Montpellier - Val d'Aurelle
  More Information

Responsible Party: Institut du Cancer de Montpellier - Val d'Aurelle
ClinicalTrials.gov Identifier: NCT00870415     History of Changes
Other Study ID Numbers: CDR0000633327
CLCC-PHRC-OP-06
CLCC-VA-2006/32
CLCC-ID-RCB-2006-A00694-47
INCA-RECF0638
First Submitted: March 26, 2009
First Posted: March 27, 2009
Last Update Posted: August 21, 2017
Last Verified: August 2017

Keywords provided by Institut du Cancer de Montpellier - Val d'Aurelle:
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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases