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Breast-Conserving Surgery Techniques in Treating Women With Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00870415
First received: March 26, 2009
Last updated: January 7, 2011
Last verified: July 2009
History of Changes
  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
Primary Purpose: Treatment
Official Title: Multicenter (Phase II) Study of Oncoplastic Surgical Techniques for Breast Conservation in Breast Cancers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Percentage of histologically healthy margins maintained during resection [ Designated as safety issue: No ]

Estimated Enrollment: 352
Study Start Date: April 2007
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00870415

Locations
France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle Recruiting
Montpellier, France, 34298
Contact: Philippe Rouanet, MD, PhD     04-67-61-3071     prouanet@valdorel.fnclcc.fr    
Sponsors and Collaborators
Centre Val d'Aurelle - Paul Lamarque
Investigators
Principal Investigator: Philippe Rouanet, MD, PhD Centre Val d'Aurelle - Paul Lamarque
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

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
Study First Received: March 26, 2009
Last Updated: January 7, 2011
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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

ClinicalTrials.gov processed this record on May 16, 2013