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OpenTrials
Completed

NCT Number: NCT00870415

Breast-Conserving Surgery Techniques in Treating Women With Breast Cancer

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.

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Key information

Conditions

Breast Cancer Adenocarcinoma Breast Diseases Breast Neoplasms Carcinoma Carcinoma, Ductal Carcinoma, Ductal, Breast Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Glandular and Epithelial Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–120 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, 34298, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

quality-of-life assessment

Procedure

therapeutic conventional surgery

Procedure

Primary outcomes

  1. Percentage of histologically healthy margins maintained during resection

    Time frame: From inclusion to end of intervention

Sponsors and collaborators

Lead sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Mar 27, 2009
Registry last updated
Aug 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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