Combination Chemotherapy in Treating Women With Stage I Breast Cancer

NCT00055679 | Completed Phase 3 DMC

• 3 other identifiers: PACS05 UC-0140-0106FRE-FNCLCC-PACS-05/0106EU-20239
• Study Type: interventional
• Target: 1,512
• Locations: 1 country
• Sites: 72

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating early breast cancer. PURPOSE: Randomized phase III trial to determine the effectiveness of different regimens of combination chemotherapy in treating women who have stage I breast cancer.

Conditions

Breast Cancer

Keywords

stage I breast cancer

Outcome Measures

Primary Outcomes (1)

• Efficacy, in terms of 5-year survival

  5 years from randomization

Secondary Outcomes (3)

• Event free survival

  5 years from randomization

• Toxicity

  5 years from randomization

• Biological factors significant for prognosis and prediction of survival

  5 years from randomization

Study Arms (2)

6 FEC

ACTIVE COMPARATOR

6 cycles of CYCLOPHOSPHAMIDE + EPIRUBICINE + 5-FLUOROURACILE

Drug: cyclophosphamide; Drug: epirubicin hydrochloride; Drug: fluorouracil

4 FEC

EXPERIMENTAL

4 cycles of CYCLOPHOSPHAMIDE + EPIRUBICINE + 5-FLUOROURACILE

Drug: cyclophosphamide; Drug: epirubicin hydrochloride; Drug: fluorouracil

Interventions

cyclophosphamide DRUG

4 FEC; 6 FEC

epirubicin hydrochloride DRUG

4 FEC; 6 FEC

fluorouracil DRUG

4 FEC; 6 FEC

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed nonmetastatic, unilateral adenocarcinoma of the breast * Stage I * No clinically or radiologically suspicious metastases * No positive sentinel lymph nodes by immunohistochemistry for tumors less than 2 cm * No clinically proven positive axillary lymph nodes * Tumor cells found on immunohistochemistry only allowed * No clinically or radiologically contralateral suspicious lesions * No deeply adherent disease * No cutaneous invasion * No inflammatory disease * Complete surgical resection within the past 42 days * At least 8 lymph nodes removed * Tumor at least 1 cm with no residual disease * Presenting with at least 1 of the following factors of a poor prognosis: * Tumor greater than 2 cm * Hormone receptor negative tumor * Grade II or III * 35 years old or under * Hormone receptor status: * Positive or negative PATIENT CHARACTERISTICS: Age * 18 to 65 Sex * Female Menopausal status * Not specified Performance status * WHO 0-1 Life expectancy * Not specified Hematopoietic * WBC at least 2,000/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * Bilirubin no greater than 1.25 times upper limit of normal (ULN) * AST and ALT no greater than 1.25 times ULN * Alkaline phosphatase no greater than 2.5 times ULN * No chronic hepatitis B * No active hepatitis C Renal * Creatinine no greater than 1.25 times ULN Pulmonary * FEV normal Other * Not pregnant or nursing * HIV negative * No prior breast cancer or other malignancy * No familial, social, or geographical reason that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy Endocrine therapy * No prior anticancer hormone therapy Radiotherapy * No prior radiotherapy Surgery * See Disease Characteristics

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

Sponsors & Collaborators

• UNICANCER: lead

Study Sites (72)

Clinique Claude Bernard

Albi, 81000, France

Location

Centre Paul Papin

Angers, 49036, France

Location

Centre Hospitalier d'Annecy

Annecy, 74011 Cedex, France

Location

Centre Hospitalier Victor Dupouy

Argenteuil, 95107, France

Location

Centre Hospital General Robert Ballanger

Aulnay-sous-Bois, 93602, France

Location

Centre Hospitalier d'Auxerre

Auxerre, 89011, France

Location

Institut Sainte Catherine

Avignon, 84082, France

Location

Centre Hospitalier de la Cote Basque

Bayonne, 64100, France

Location

C.H.G. Beauvais

Beauvais, 60021, France

Location

Centre Hospitalier General

Belfort, 90000, France

Location

Institut Bergonie

Bordeaux, 33076, France

Location

Clinique Tivoli

Bordeaux, F-33000, France

Location

Polyclinique Bordeaux Nord Aquitaine

Boucher, 33300, France

Location

Centre Hospitalier Docteur Duchenne

Boulogne-sur-Mer, 62200, France

Location

Centre Hospitalier de Fleyriat

Bourg-en-Bresse, 01012, France

Location

Centre Hospitalier Jacques-Coeur

Bourges, 18016, France

Location

CHU Hopital A. Morvan

Brest, 29609, France

Location

Centre Hospitalier General

Brivé, 19101, France

Location

Polyclinique Du Parc Centre Maurice Tubiana

Caen, 14052, France

Location

Centre Regional Francois Baclesse

Caen, 14076, France

Location

Centre Hospitalier Regional de Chambery

Chambéry, 73011, France

Location

Clinique Prive Paul d'Egine

Champigny-sur-Marne, 94500, France

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

Hopital Louis Pasteur

Colmar, 68024, France

Location

Clinique des Cedres

Cornebarrieu, 31700, France

Location

Centre de Lutte Contre le Cancer Georges-Francois Leclerc

Dijon, 21079, France

Location

Centre Hospitalier Draguignan

Draguignan, 83300, France

Location

CHU de Grenoble - Hopital de la Tronche

Grenoble, 38043, France

Location

Institut Prive de Cancerologie

Grenoble, 38100, France

Location

Centre Hospitalier Departemental

La Roche-sur-Yon, 85025, France

Location

Centre Hospitalier de Lagny

Lagny-sur-Marne, 77405, France

Location

Hopital Andre Mignot

Le Chesnay, 78157, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Centre Hospitalier Bretagne Sud

Lorient, 56322, France

Location

Hopital Hotel Dieu

Lyon, 69288, France

Location

Hopital de la Croix Rousse

Lyon, 69317, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

Hopital Edouard Herriot

Lyon, 69437, France

Location

Centre de Radiotherapie et Oncologie Saint-Faron

Mareuil-lès-Meaux, 77100, France

Location

Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

Marseille, 13273, France

Location

Hopital Notre-Dame de Bon Secours

Metz, 57038, France

Location

Centre Hospitalier General Andre Boulloche

Montbéliard, 25209, France

Location

Intercommunal Hospital

Montfermeil, 93370, France

Location

Centre Azureen de Cancerologie

Mougins, 06250, France

Location

Centre Hospitalier de Mulhouse

Mulhouse, 68051, France

Location

Clinique D'Occitanie

Muret, 31600, France

Location

Centre Catherine de Sienne

Nantes, 02, France

Location

Centre Regional Rene Gauducheau

Nantes-Saint-Herblain, 44805, France

Location

Clinique Les Genets

Narbonne, 11100, France

Location

Clinique Hartmann

Neuilly-sur-Seine, 92200, France

Location

Hopital Saint Antoine

Paris, 75571, France

Location

Hopital Tenon

Paris, 75970, France

Location

C.H.G. De Pau

Pau, 64046 Universite Cedex, France

Location

Clinique Saint - Pierre

Perpignan, France

Location

Polyclinique Francheville

Périgueux, 24004, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

CHU Poitiers

Poitiers, 86021, France

Location

Centre Hospitalier de Cornouaille

Quimper, 29107, France

Location

Centre Eugene Marquis

Rennes, 35042, France

Location

CHG Roanne

Roanne, F-42300, France

Location

Centre Hospitalier de Rodez

Rodez, 12027, France

Location

Clinique Armoricaine De Radiologie

Saint-Brieuc, F-22015, France

Location

Centre Rene Huguenin

Saint-Cloud, 92211, France

Location

Centre Paul Strauss

Strasbourg, 67065, France

Location

Centre Medico-Chirurgical Foch

Suresnes, 92151, France

Location

Polyclinique de L'Ormeau

Tarbes, 65000, France

Location

Institut Claudius Regaud

Toulouse, 31052, France

Location

Clinique Pasteur

Toulouse, 31076, France

Location

Clinique Du Parc

Toulouse, 31078, France

Location

Clinique du Chateau

Toulouse, 31080, France

Location

Hopital J. Ducuing

Toulouse, France

Location

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54511, France

Location

Related Publications (1)

• Kerbrat P, Desmoulins I, Roca L, Levy C, Lortholary A, Marre A, Delva R, Rios M, Viens P, Brain E, Serin D, Edel M, Debled M, Campone M, Mourret-Reynier MA, Bachelot T, Foucher-Goudier MJ, Asselain B, Lemonnier J, Martin AL, Roche H. Optimal duration of adjuvant chemotherapy for high-risk node-negative (N-) breast cancer patients: 6-year results of the prospective randomised multicentre phase III UNICANCER-PACS 05 trial (UCBG-0106). Eur J Cancer. 2017 Jul;79:166-175. doi: 10.1016/j.ejca.2017.03.004. Epub 2017 May 11.

  PMID: 28501763 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cyclophosphamide; Epirubicin; Fluorouracil

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; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Pierre Kerbrat, MD, PhD

  Centre Eugene Marquis

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2003
• First Posted: March 7, 2003
• Study Start: August 1, 2002
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2013
• Last Updated: June 18, 2013

Record last verified: 2013-06

Locations

FR (72)