Breast-Conserving Therapy Compared With Mastectomy Followed By Radiation Therapy in Treating Women With Locally Advanced Breast Cancer Previously Treated With Chemotherapy

July 17, 2012 updated by: European Organisation for Research and Treatment of Cancer - EORTC

Conservative Local Treatment Versus Mastectomy After Induction Chemotherapy In Locally Advanced Breast Cancer: A Randomized Phase III Study

RATIONALE: Breast-conserving treatments such as radiation therapy or limited surgery are less invasive than mastectomy and may improve the quality of life. It is not yet known if breast-conserving treatments are as effective as mastectomy followed by radiation therapy in treating locally advanced breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of breast-conserving therapy with mastectomy followed by radiation therapy in treating women who have locally advanced breast cancer that has been previously treated with chemotherapy.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Compare the overall survival and time to loco-regional failure in women with locally advanced breast cancer treated with breast-conserving local therapy vs mastectomy followed by radiotherapy after they have received prior induction chemotherapy.
  • Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, initial stage (T0, T1, T2, T3, or Tx vs T4), response to prior induction chemotherapy (complete response (CR) vs other), and menopausal status (premenopausal vs postmenopausal). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo mastectomy followed by radiotherapy.

  • Arm II: Patients receive breast-conserving treatment comprising 1 of 3 of the following therapeutic options:

    • Regimen A: Patients receive radiotherapy alone.
    • Regimen B: Patients with a partial response (PR) to prior induction chemotherapy undergo limited surgery followed by radiotherapy. Patients with a CR to prior induction chemotherapy undergo radiotherapy alone.
    • Regimen C: Patients with a partial response (PR) or CR to prior induction chemotherapy undergo radiotherapy alone.

Patients with a CR to radiotherapy receive no further treatment. Patients with a PR to radiotherapy undergo limited surgery.

Quality of life is assessed at baseline, at the end of therapy, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Patients are followed within 1 month, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 1,300 patients (650 per treatment arm) will be accrued for this study within 5 years.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, B-1050
        • Centre Hospitalier Etterbeek Ixelles
      • Leuven, Belgium, B-3000
        • U.Z. Gasthuisberg
  • Chile
      • Santiago, Chile, 10
        • Instituto de Radiomedicina
  • Israel
      • Haifa, Israel, 31096
        • Rambam Medical Center
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Akademisch Medisch Centrum
      • Arnhem, Netherlands, 6815 AD
        • Arnhems Radiotherapeutisch Instituut
      • Leiden, Netherlands, 2300 CA
        • Leiden University Medical Center
      • Tilburg, Netherlands, 5042 SB
        • Dr. Bernard Verbeeten Instituut
  • Poland
      • Gdansk, Poland, 80-211
        • Medical University of Gdansk
      • Poznan, Poland, 60-355
        • Karol Marcinkowski University
      • Warsaw, Poland, 02-781
        • Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
  • Portugal
      • Coimbra, Portugal, 3049
        • Hospitais da Universidade de Coimbra (HUC)
  • United Kingdom
    • England
      • London, England, United Kingdom, W6 8RF
        • Charing Cross Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed locally advanced breast cancer

    • T3 inoperable, N0-N2
    • Any T, N2
    • T4, N0-N2
    • Inflammatory breast carcinoma
  • Prior treatment with 4-6 courses of standard induction chemotherapy or active investigational regimens completed within the past 4 weeks
  • Residual tumor size less than 5 cm
  • No fixed axillary lymph nodes
  • No multifocal or bilateral breast cancer
  • No clinical suspicion of extensive ductal carcinoma in situ
  • No unresolved skin edema

  • No distant metastases (including ipsilateral supraclavicular node)

    • Positive bone scan allowed provided there are no bone metastases on x-ray

  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age:

  • Any age

Sex:

  • Female

Menopausal status:

  • Not specified

Performance status:

  • WHO 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • Neutrophil count at least 2,000/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin less than 1.5 times normal
  • SGOT and SGPT no greater than 2 times normal
  • Alkaline phosphatase no greater than 2 times normal

Renal:

  • Creatinine less than 1.5 times normal

Other:

  • No other prior or concurrent malignancy except adequately treated squamous cell or basal cell skin cancer or adequately treated cone-biopsied carcinoma in situ of the cervix
  • No serious underlying medical illness that would preclude study
  • No psychiatric or addictive disorder that would preclude study
  • No contraindication to study treatment
  • Not pregnant
  • Fertile patients must use effective barrier contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics

Endocrine therapy:

  • No concurrent hormonal replacement therapy
  • No concurrent oral contraceptives

Radiotherapy:

  • See Disease Characteristics
  • No prior radiotherapy for breast cancer

Surgery:

  • No prior surgery for breast cancer other than biopsy for diagnosis confirmation

Other:

  • No other prior systemic therapy for breast cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Collaborators

Central and Eastern European Oncology Group
Grupo Oncologico Cooperativo Chileno de Investigation
International Collaborative Cancer Group

Investigators

  • Study Chair: Jacek Jassem, MD, PhD, Medical University of Gdansk
  • Study Chair: G. van Tienhoven, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • Study Chair: Marzena Welnicka-Jaskiewicz, MD, Medical University of Gdansk
  • Study Chair: Rodrigo Arriagada, MD, Instituto de Radiomedicina
  • Study Chair: Marie Emson, BSc, International Collaborative Cancer Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2001

Primary Completion (Actual)

December 1, 2003

Study Registration Dates

First Submitted

January 4, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

July 18, 2012

Last Update Submitted That Met QC Criteria

July 17, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-10974-22002
  • EORTC-10974
  • CEEOG-EORTC-10974
  • EORTC-22002
  • GOCCHI-EORTC-10974
  • ICCG-EORTC-10974
  • EORTC-BIG-0002
  • LAMANOMA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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