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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

March 26, 2009
January 7, 2011
April 2007
April 2009   (final data collection date for primary outcome measure)
Percentage of histologically healthy margins maintained during resection [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00870415 on ClinicalTrials.gov Archive Site
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Breast-Conserving Surgery Techniques in Treating Women With Breast Cancer
Multicenter (Phase II) Study of Oncoplastic Surgical Techniques for Breast Conservation in Breast Cancers

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.

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.
Interventional
Phase 2
Allocation: Non-Randomized
Primary Purpose: Treatment
Breast Cancer
  • Procedure: quality-of-life assessment
  • Procedure: therapeutic conventional surgery
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
352
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April 2009   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Not Provided
France
 
NCT00870415
CDR0000633327, CLCC-PHRC-OP-06, CLCC-VA-2006/32, CLCC-ID-RCB-2006-A00694-47, INCA-RECF0638
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Centre Val d'Aurelle - Paul Lamarque
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Principal Investigator: Philippe Rouanet, MD, PhD Centre Val d'Aurelle - Paul Lamarque
National Cancer Institute (NCI)
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP