Combination Chemotherapy in Treating Women With Stage I Breast Cancer

Breast Cancer Clinical Trial

Official title:

Phase III Randomized Study Of Adjuvant Fluourouracil, Epirubicin And Cyclophosphamide, In Women With Stage I Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00055679
• Other study ID #: PACS05 UC-0140-0106
• Secondary ID: FRE-FNCLCC-PACS-
• Status: Completed
• Phase: Phase 3
• First received: March 6, 2003
• Last updated: June 17, 2013
• Start date: August 2002
• Est. completion date: June 2013

Study information

• Verified date: June 2013
• Source: UNICANCER
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1512
• Est. completion date: June 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• cyclophosphamide

• epirubicin hydrochloride

• fluorouracil

Locations

Country	Name	City	State
France	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	Clinique Tivoli	Bordeaux
France	Institut Bergonie	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	Brive
France	Centre Regional Francois Baclesse	Caen
France	Polyclinique Du Parc Centre Maurice Tubiana	Caen
France	Centre Hospitalier Regional de Chambery	Chambery
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	Centre Leon Berard	Lyon
France	Hopital de la Croix Rousse	Lyon
France	Hopital Edouard Herriot	Lyon
France	Hopital Hotel Dieu	Lyon
France	Centre de Radiotherapie et Oncologie Saint-Faron	Mareuil Les 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	Montbeliard
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	Polyclinique Francheville	Perigueux
France	Clinique Saint - Pierre	Perpignan
France	Centre Hospitalier Lyon Sud	Pierre Benite
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	Clinique du Chateau	Toulouse
France	Clinique Du Parc	Toulouse
France	Clinique Pasteur	Toulouse
France	Hopital J. Ducuing	Toulouse
France	Institut Claudius Regaud	Toulouse
France	Centre Alexis Vautrin	Vandoeuvre-les-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
UNICANCER

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy, in terms of 5-year survival		5 years from randomization	No
Secondary	Event free survival		5 years from randomization	No
Secondary	Toxicity		5 years from randomization	Yes
Secondary	Biological factors significant for prognosis and prediction of survival		5 years from randomization	No