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Breast-Conserving Surgery Techniques in Treating Women With Breast Cancer

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ClinicalTrials.gov Identifier: NCT00870415
Recruitment Status : Completed
First Posted : March 27, 2009
Last Update Posted : August 21, 2017
Sponsor:
Information provided by (Responsible Party):
Institut du Cancer de Montpellier - Val d'Aurelle

Brief 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.


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

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 263 participants
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
Study Start Date : April 2007
Actual Primary Completion Date : April 2009
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Surgerie Procedure: quality-of-life assessment Procedure: therapeutic conventional surgery



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


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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

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

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 Posted: March 27, 2009    Key Record Dates
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