Combination Chemotherapy in Treating Women With Stage I Breast Cancer
NCT ID: NCT00055679
Last Updated: 2013-06-18
Study Results
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Basic Information
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COMPLETED
PHASE3
1512 participants
INTERVENTIONAL
2002-08-31
2013-06-30
Brief Summary
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PURPOSE: Randomized phase III trial to determine the effectiveness of different regimens of combination chemotherapy in treating women who have stage I breast cancer.
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Detailed Description
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* Compare the efficacy of 4 vs 6 courses of adjuvant fluorouracil, epirubicin, and cyclophosphamide, in terms of 5-year survival, in women with stage I breast cancer.
* Compare the toxicity of these regimens in these patients.
* Determine the correlation of length of survival with biological factors in patients treated with these regimens.
* Determine biological factors significant for prognosis and prediction of survival of patients treated with these regimens.
* Determine the overall survival of patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive the same regimen as in arm I for up to 4 courses. After completion of chemotherapy, patients undergo radiotherapy 5 days a week for 6 weeks. Patients who are estrogen or progesterone receptor positive also receive oral tamoxifen daily for 5 years, beginning after completion of chemotherapy.
Patients are followed every 6 months for 5 years.
PROJECTED ACCRUAL: A total of 1,512 patients (756 per treatment arm) will be accrued for this study within 3 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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6 FEC
6 cycles of CYCLOPHOSPHAMIDE + EPIRUBICINE + 5-FLUOROURACILE
cyclophosphamide
epirubicin hydrochloride
fluorouracil
4 FEC
4 cycles of CYCLOPHOSPHAMIDE + EPIRUBICINE + 5-FLUOROURACILE
cyclophosphamide
epirubicin hydrochloride
fluorouracil
Interventions
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cyclophosphamide
epirubicin hydrochloride
fluorouracil
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
65 Years
FEMALE
No
Sponsors
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UNICANCER
OTHER
Responsible Party
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Principal Investigators
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Pierre Kerbrat, MD, PhD
Role: STUDY_CHAIR
Centre Eugene Marquis
Locations
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Clinique Claude Bernard
Albi, , France
Centre Paul Papin
Angers, , France
Centre Hospitalier d'Annecy
Annecy, , France
Centre Hospitalier Victor Dupouy
Argenteuil, , France
Centre Hospital General Robert Ballanger
Aulnay-sous-Bois, , France
Centre Hospitalier d'Auxerre
Auxerre, , France
Institut Sainte Catherine
Avignon, , France
Centre Hospitalier de la Cote Basque
Bayonne, , France
C.H.G. Beauvais
Beauvais, , France
Centre Hospitalier General
Belfort, , France
Institut Bergonie
Bordeaux, , France
Clinique Tivoli
Bordeaux, , France
Polyclinique Bordeaux Nord Aquitaine
Boucher, , France
Centre Hospitalier Docteur Duchenne
Boulogne-sur-Mer, , France
Centre Hospitalier de Fleyriat
Bourg-en-Bresse, , France
Centre Hospitalier Jacques-Coeur
Bourges, , France
CHU Hopital A. Morvan
Brest, , France
Centre Hospitalier General
Brivé, , France
Polyclinique Du Parc Centre Maurice Tubiana
Caen, , France
Centre Regional Francois Baclesse
Caen, , France
Centre Hospitalier Regional de Chambery
Chambéry, , France
Clinique Prive Paul d'Egine
Champigny-sur-Marne, , France
Centre Jean Perrin
Clermont-Ferrand, , France
Hopital Louis Pasteur
Colmar, , France
Clinique des Cedres
Cornebarrieu, , France
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
Dijon, , France
Centre Hospitalier Draguignan
Draguignan, , France
CHU de Grenoble - Hopital de la Tronche
Grenoble, , France
Institut Prive de Cancerologie
Grenoble, , France
Centre Hospitalier Departemental
La Roche-sur-Yon, , France
Centre Hospitalier de Lagny
Lagny-sur-Marne, , France
Hopital Andre Mignot
Le Chesnay, , France
Centre Oscar Lambret
Lille, , France
Centre Hospitalier Bretagne Sud
Lorient, , France
Hopital Hotel Dieu
Lyon, , France
Hopital de la Croix Rousse
Lyon, , France
Centre Leon Berard
Lyon, , France
Hopital Edouard Herriot
Lyon, , France
Centre de Radiotherapie et Oncologie Saint-Faron
Mareuil-lès-Meaux, , France
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, , France
Hopital Notre-Dame de Bon Secours
Metz, , France
Centre Hospitalier General Andre Boulloche
Montbéliard, , France
Intercommunal Hospital
Montfermeil, , France
Centre Azureen de Cancerologie
Mougins, , France
Centre Hospitalier de Mulhouse
Mulhouse, , France
Clinique D'Occitanie
Muret, , France
Centre Catherine de Sienne
Nantes, , France
Centre Regional Rene Gauducheau
Nantes-Saint-Herblain, , France
Clinique Les Genets
Narbonne, , France
Clinique Hartmann
Neuilly-sur-Seine, , France
Hopital Saint Antoine
Paris, , France
Hopital Tenon
Paris, , France
C.H.G. De Pau
Pau, , France
Clinique Saint - Pierre
Perpignan, , France
Polyclinique Francheville
Périgueux, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
CHU Poitiers
Poitiers, , France
Centre Hospitalier de Cornouaille
Quimper, , France
Centre Eugene Marquis
Rennes, , France
CHG Roanne
Roanne, , France
Centre Hospitalier de Rodez
Rodez, , France
Clinique Armoricaine De Radiologie
Saint-Brieuc, , France
Centre Rene Huguenin
Saint-Cloud, , France
Centre Paul Strauss
Strasbourg, , France
Centre Medico-Chirurgical Foch
Suresnes, , France
Polyclinique de L'Ormeau
Tarbes, , France
Institut Claudius Regaud
Toulouse, , France
Clinique Pasteur
Toulouse, , France
Clinique Du Parc
Toulouse, , France
Clinique du Chateau
Toulouse, , France
Hopital J. Ducuing
Toulouse, , France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, , France
Countries
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References
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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.
Other Identifiers
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FRE-FNCLCC-PACS-05/0106
Identifier Type: -
Identifier Source: secondary_id
EU-20239
Identifier Type: -
Identifier Source: secondary_id
PACS05 UC-0140-0106
Identifier Type: -
Identifier Source: org_study_id
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