Combination Chemotherapy in Treating Women With Stage I Breast Cancer

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Drug: cyclophosphamide; Drug: epirubicin hydrochloride; Drug: fluorouracil	Phase 3

Detailed Description:

OBJECTIVES:

• 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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	1512 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Phase III Randomized Study Of Adjuvant Fluourouracil, Epirubicin And Cyclophosphamide, In Women With Stage I Breast Cancer
Study Start Date :	August 2002
Actual Primary Completion Date :	June 2012
Actual Study Completion Date :	June 2013

Arms and Interventions

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Arm	Intervention/treatment
Active Comparator: 6 FEC; 6 cycles of CYCLOPHOSPHAMIDE + EPIRUBICINE + 5-FLUOROURACILE	Drug: cyclophosphamide Drug: epirubicin hydrochloride Drug: fluorouracil
Experimental: 4 FEC; 4 cycles of CYCLOPHOSPHAMIDE + EPIRUBICINE + 5-FLUOROURACILE	Drug: cyclophosphamide Drug: epirubicin hydrochloride Drug: fluorouracil

Outcome Measures

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Primary Outcome Measures :

1. Efficacy, in terms of 5-year survival [ Time Frame: 5 years from randomization ]

Secondary Outcome Measures :

1. Event free survival [ Time Frame: 5 years from randomization ]
2. Toxicity [ Time Frame: 5 years from randomization ]
3. Biological factors significant for prognosis and prediction of survival [ Time Frame: 5 years from randomization ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Locations

France
Clinique Claude Bernard
Albi, France, 81000
Centre Paul Papin
Angers, France, 49036
Centre Hospitalier d'Annecy
Annecy, France, 74011 Cedex
Centre Hospitalier Victor Dupouy
Argenteuil, France, 95107
Centre Hospital General Robert Ballanger
Aulnay Sous Bois, France, 93602
Centre Hospitalier d'Auxerre
Auxerre, France, 89011
Institut Sainte Catherine
Avignon, France, 84082
Centre Hospitalier de la Cote Basque
Bayonne, France, 64100
C.H.G. Beauvais
Beauvais, France, 60021
Centre Hospitalier General
Belfort, France, 90000
Institut Bergonie
Bordeaux, France, 33076
Clinique Tivoli
Bordeaux, France, F-33000
Polyclinique Bordeaux Nord Aquitaine
Boucher, France, 33300
Centre Hospitalier Docteur Duchenne
Boulogne Sur Mer, France, 62200
Centre Hospitalier de Fleyriat
Bourg En Bresse, France, 01012
Centre Hospitalier Jacques-Coeur
Bourges, France, 18016
CHU Hopital A. Morvan
Brest, France, 29609
Centre Hospitalier General
Brive, France, 19101
Polyclinique Du Parc Centre Maurice Tubiana
Caen, France, 14052
Centre Regional Francois Baclesse
Caen, France, 14076
Centre Hospitalier Regional de Chambery
Chambery, France, 73011
Clinique Prive Paul d'Egine
Champigny-Sur-Marne, France, 94500
Centre Jean Perrin
Clermont-Ferrand, France, 63011
Hopital Louis Pasteur
Colmar, France, 68024
Clinique des Cedres
Cornebarrieu, France, 31700
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
Dijon, France, 21079
Centre Hospitalier Draguignan
Draguignan, France, 83300
CHU de Grenoble - Hopital de la Tronche
Grenoble, France, 38043
Institut Prive de Cancerologie
Grenoble, France, 38100
Centre Hospitalier Departemental
La Roche Sur Yon, France, 85025
Centre Hospitalier de Lagny
Lagny Sur Marne, France, 77405
Hopital Andre Mignot
Le Chesnay, France, 78157
Centre Oscar Lambret
Lille, France, 59020
Centre Hospitalier Bretagne Sud
Lorient, France, 56322
Hopital Hotel Dieu
Lyon, France, 69288
Hopital de la Croix Rousse
Lyon, France, 69317
Centre Leon Berard
Lyon, France, 69373
Hopital Edouard Herriot
Lyon, France, 69437
Centre de Radiotherapie et Oncologie Saint-Faron
Mareuil Les Meaux, France, 77100
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, France, 13273
Hopital Notre-Dame de Bon Secours
Metz, France, 57038
Centre Hospitalier General Andre Boulloche
Montbeliard, France, 25209
Intercommunal Hospital
Montfermeil, France, 93370
Centre Azureen de Cancerologie
Mougins, France, 06250
Centre Hospitalier de Mulhouse
Mulhouse, France, 68051
Clinique D'Occitanie
Muret, France, 31600
Centre Regional Rene Gauducheau
Nantes-Saint-Herblain, France, 44805
Centre Catherine de Sienne
Nantes, France, 02
Clinique Les Genets
Narbonne, France, 11100
Clinique Hartmann
Neuilly sur Seine, France, 92200
Hopital Saint Antoine
Paris, France, 75571
Hopital Tenon
Paris, France, 75970
C.H.G. De Pau
Pau, France, 64046 Universite Cedex
Polyclinique Francheville
Perigueux, France, 24004
Clinique Saint - Pierre
Perpignan, France
Centre Hospitalier Lyon Sud
Pierre Benite, France, 69495
CHU Poitiers
Poitiers, France, 86021
Centre Hospitalier de Cornouaille
Quimper, France, 29107
Centre Eugene Marquis
Rennes, France, 35042
CHG Roanne
Roanne, France, F-42300
Centre Hospitalier de Rodez
Rodez, France, 12027
Clinique Armoricaine De Radiologie
Saint Brieuc, France, F-22015
Centre Rene Huguenin
Saint Cloud, France, 92211
Centre Paul Strauss
Strasbourg, France, 67065
Centre Medico-Chirurgical Foch
Suresnes, France, 92151
Polyclinique de L'Ormeau
Tarbes, France, 65000
Institut Claudius Regaud
Toulouse, France, 31052
Clinique Pasteur
Toulouse, France, 31076
Clinique Du Parc
Toulouse, France, 31078
Clinique du Chateau
Toulouse, France, 31080
Hopital J. Ducuing
Toulouse, France
Centre Alexis Vautrin
Vandoeuvre-les-Nancy, France, 54511

Sponsors and Collaborators

UNICANCER

Investigators

Study Chair:	Pierre Kerbrat, MD, PhD	Centre Eugene Marquis

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kerbrat P, Desmoulins I, Roca L, Levy C, Lortholary A, Marre A, Delva R, Rios M, Viens P, Brain É, Serin D, Edel M, Debled M, Campone M, Mourret-Reynier MA, Bachelot T, Foucher-Goudier MJ, Asselain B, Lemonnier J, Martin AL, Roché 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.

Responsible Party:	UNICANCER
ClinicalTrials.gov Identifier:	NCT00055679 History of Changes
Other Study ID Numbers:	PACS05 UC-0140-0106; FRE-FNCLCC-PACS-05/0106; EU-20239
First Posted:	March 7, 2003
Last Update Posted:	June 18, 2013
Last Verified:	June 2013

Keywords provided by UNICANCER:

stage I breast cancer

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Cyclophosphamide; Fluorouracil; Epirubicin; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Antirheumatic Agents	Antineoplastic Agents, Alkylating; Alkylating Agents; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Myeloablative Agonists; Antimetabolites; Antimetabolites, Antineoplastic; Antibiotics, Antineoplastic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Enzyme Inhibitors