Chemotherapy Plus Surgery in Treating Women With Breast Cancer

NCT00003013 | Completed Phase 3

• 3 other identifiers: CDR0000065593INT-23/96EU-97001
• Study Type: interventional
• Target: 450
• Locations: 10 countries
• Sites: 22

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining surgery with chemotherapy may kill more tumor cells. It is not yet known which treatment regimen is more effective for breast cancer. PURPOSE: Randomized phase III trial to study the effectiveness of chemotherapy plus surgery in treating women who have breast cancer.

Conditions

Breast Cancer

Keywords

stage II breast cancer; stage IIIA breast cancer

Interventions

CMF regimen DRUG

cyclophosphamide DRUG

doxorubicin hydrochloride DRUG

fluorouracil DRUG

methotrexate DRUG

paclitaxel DRUG

tamoxifen citrate DRUG

conventional surgery PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Unilateral carcinoma of the breast that has not been previously treated with standard therapies * Tumor greater than 2 cm in its maximum diameter as assessed by mammography, except: * No locally advanced disease, i.e., no tumor with direct extension to the chest wall or skin * No metastatic disease * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 18 to 70 Sex: * Female Menopausal status: * Not specified Performance status: * Karnofsky 80-100% Hematopoietic: * Granulocyte count at least 2,000/mm\^3 * Platelet count at least 150,000/mm\^3 Hepatic: * Bilirubin within upper limits of normal (ULN) * Alkaline phosphatase no greater than 1.5 times ULN * AST no greater than 1.5 times ULN * No chronic active hepatitis Renal: * Creatinine within ULN Cardiovascular: * No prior atrial or ventricular arrhythmias * No history of congestive heart failure * No myocardial infarction within the past 6 months * No uncontrolled hypertension Neurologic: * No pre-existing motor or sensory neuropathy greater than grade 1 Other: * Not pregnant or nursing * Fertile patients must use effective contraception * No active infection * No history of second malignancy except adequately treated basal cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior biologic therapy Chemotherapy: * No prior chemotherapy Endocrine therapy: * No prior endocrine therapy Radiotherapy: * No prior radiotherapy Surgery: * No prior surgery * No prior surgical biopsy of breast nodule

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

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead

Study Sites (28)

Kaiser Franz Josef Hospital

Vienna, A-1100, Austria

Location

Radiotherapy Institute

Ostrava-Poruba, 70852, Czechia

Location

University of Tartu

Tartu, 51003, Estonia

Location

Frauenklinik Vom Roten Kreuz

Munich, 80637, Germany

Location

Semmelweis University

Budapest, 1082, Hungary

Location

Uzsoki Hospital

Budapest, 1145, Hungary

Location

Policlinico Monteluce

Perugia, 06122, Italy

Location

Ospedale St. Santa Chiara

Pisa, 56100, Italy

Location

Centro di Riferimento Oncologico - Aviano

Trento, 38100, Italy

Location

Universita Degli Studi di Udine

Udine, 33100, Italy

Location

Ospedale San Bortolo

Vicenza, 36100, Italy

Location

Latvian Cancer Center

Riga, 1079, Latvia

Location

Regional Center of Oncology

Bydgoszcz, 85-796, Poland

Location

Jagiellonian University

Krakow (Cracow), 31-826, Poland

Location

Szpital Kliniczny NR 1

Poznan, PL-61-878, Poland

Location

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

Warsaw, 02-781, Poland

Location

Russian Academy of Medical Sciences Cancer Research Center

Moscow, 115478, Russia

Location

Moscow Clinical Dispenser

Moscow, 129128, Russia

Location

N. A. Semashko Central Clinical Hospital

Moscow, 129128, Russia

Location

Regional Oncology Clinic

Murmansk, 183047, Russia

Location

Petrov Research Institute of Oncology

Saint Petersburg, 197758, Russia

Location

St. Elizabeth Cancer Institute Hospital

Bratislava, SK-81250, Slovakia

Location

Hospital de la Santa Cruz I Sant Pau

Barcelona, 08025, Spain

Location

Hospital General Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Clinico Universitario - Malaga

Málaga, 29010, Spain

Location

Instituto Valenciano De Oncologia

Valencia, 46009, Spain

Location

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

Location

Related Publications (1)

• Gianni L, Baselga J, Eiermann W, Porta VG, Semiglazov V, Lluch A, Zambetti M, Sabadell D, Raab G, Cussac AL, Bozhok A, Martinez-Agullo A, Greco M, Byakhov M, Lopez JJ, Mansutti M, Valagussa P, Bonadonna G. Phase III trial evaluating the addition of paclitaxel to doxorubicin followed by cyclophosphamide, methotrexate, and fluorouracil, as adjuvant or primary systemic therapy: European Cooperative Trial in Operable Breast Cancer. J Clin Oncol. 2009 May 20;27(15):2474-81. doi: 10.1200/JCO.2008.19.2567. Epub 2009 Mar 30.

  PMID: 19332727 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

CMF regimen; Cyclophosphamide; Doxorubicin; Fluorouracil; Methotrexate; Paclitaxel; Tamoxifen; Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Therapeutics

Study Officials

• Gianni Bonadonna, MD

  Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: October 1, 1996
• Study Completion: March 1, 2009
• Last Updated: September 17, 2013

Record last verified: 2000-06

Locations

HU (2); PL (4); IT (5); SL (1); ES (1); RU (5); CZ (1); LA (1); AU (1); DE (1)