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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2006 by National Cancer Institute (NCI). Recruitment status was Active, not recruiting

First Received on January 4, 2002. Last Updated on October 6, 2010 History of Changes

Sponsor:	European Organization for Research and Treatment of Cancer - EORTC
Collaborators:	Central and Eastern European Oncology Group Grupo Oncologico Cooperativo Chileno de Investigacion - Vitacura International Collaborative Cancer Group
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00028704

Purpose

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.

Condition	Intervention	Phase
Breast Cancer	Procedure: conventional surgery Radiation: radiation therapy	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Primary Purpose: Treatment
Official Title:	Conservative Local Treatment Versus Mastectomy After Induction Chemotherapy In Locally Advanced Breast Cancer: A Randomized Phase III Study

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Mastectomy

U.S. FDA Resources

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

Study Start Date:

October 2001

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.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00028704

Locations

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

Sponsors and Collaborators

European Organization for Research and Treatment of Cancer - EORTC

Central and Eastern European Oncology Group

Grupo Oncologico Cooperativo Chileno de Investigacion - Vitacura

International Collaborative Cancer Group

Investigators

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

More Information

Additional Information:

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

Publications:

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. Epub 2005 Nov 7. No abstract available.

Sinacki M, Welnicka-Jaskiewicz M, Jassem J: Conservative local treatment versus mastectomy after induction chemotherapy in locally advanced breast cancer (LAMANOMA, EORTC 10974/22002). Why this study failed? [Abstract] Eur J Cancer 2 (Suppl 3): A-286, 139, 2004.

ClinicalTrials.gov Identifier:	NCT00028704 History of Changes
Other Study ID Numbers:	CDR0000069121, EORTC-10974, CEEOG-EORTC-10974, EORTC-22002, GOCCHI-EORTC-10974, ICCG-EORTC-10974, EORTC-BIG-0002, LAMANOMA
Study First Received:	January 4, 2002
Last Updated:	October 6, 2010
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on February 12, 2012