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

NCT00028704 | Terminated Phase 3

• 8 other identifiers: EORTC-10974-22002EORTC-10974CEEOG-EORTC-10974EORTC-22002GOCCHI-EORTC-10974ICCG-EORTC-10974EORTC-BIG-0002LAMANOMA
• Study Type: interventional
• Target: 26
• Locations: 7 countries
• Sites: 13

Brief Summary

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.

Conditions

Breast Cancer

Keywords

stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; inflammatory breast cancer

Interventions

conventional surgery PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead
• Central and Eastern European Oncology Group: collaborator
• Grupo Oncologico Cooperativo Chileno de Investigation: collaborator
• International Collaborative Cancer Group: collaborator

Study Sites (13)

Centre Hospitalier Etterbeek Ixelles

Brussels, B-1050, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

Instituto de Radiomedicina

Santiago, 10, Chile

Location

Rambam Medical Center

Haifa, 31096, Israel

Location

Akademisch Medisch Centrum

Amsterdam, 1105 AZ, Netherlands

Location

Arnhems Radiotherapeutisch Instituut

Arnhem, 6815 AD, Netherlands

Location

Leiden University Medical Center

Leiden, 2300 CA, Netherlands

Location

Dr. Bernard Verbeeten Instituut

Tilburg, 5042 SB, Netherlands

Location

Medical University of Gdansk

Gdansk, 80-211, Poland

Location

Karol Marcinkowski University

Poznan, 60-355, Poland

Location

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

Warsaw, 02-781, Poland

Location

Hospitais da Universidade de Coimbra (HUC)

Coimbra, 3049, Portugal

Location

Charing Cross Hospital

London, England, W6 8RF, United Kingdom

Location

Related Publications (1)

• Sinacki M, Jassem J, van Tienhoven G. Conservative local treatment versus mastectomy after induction chemotherapy in locally advanced breast cancer: a randomised phase III study (EORTC 10974/22002, LAMANOMA)--why did this study fail? Eur J Cancer. 2005 Dec;41(18):2787-8. doi: 10.1016/j.ejca.2005.06.027. Epub 2005 Nov 7. No abstract available.

  PMID: 16274985 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Inflammatory Breast Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2002
• First Posted: January 27, 2003
• Study Start: October 1, 2001
• Primary Completion: December 1, 2003
• Last Updated: July 18, 2012

Record last verified: 2012-07

Locations

GB (1); IL (1); PT (1); CL (1); BE (2); NL (4); PL (3)