Clinical trial NCT00055679: Combination Chemotherapy in Treating Women With Stage I Breast Cancer
Official title: Phase III Randomized Study Of Adjuvant Fluourouracil, Epirubicin And Cyclophosphamide, In Women With Stage I Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: stage I breast cancer
Lead sponsor: UNICANCER
Sponsor class: OTHER
First posted: 2003-03-07
Enrollment: 1512
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Efficacy, in terms of 5-year survival
timeFrame: 5 years from randomization
Secondary outcomes:
measure: Event free survival
timeFrame: 5 years from randomization
measure: Toxicity
timeFrame: 5 years from randomization
measure: Biological factors significant for prognosis and prediction of survival
timeFrame: 5 years from randomization
Other outcomes:
Locations:
city: Albi
country: France
facility: Clinique Claude Bernard
city: Angers
country: France
facility: Centre Paul Papin
city: Annecy
country: France
facility: Centre Hospitalier d'Annecy
city: Argenteuil
country: France
facility: Centre Hospitalier Victor Dupouy
city: Aulnay Sous Bois
country: France
facility: Centre Hospital General Robert Ballanger
city: Auxerre
country: France
facility: Centre Hospitalier d'Auxerre
city: Avignon
country: France
facility: Institut Sainte Catherine
city: Bayonne
country: France
facility: Centre Hospitalier de la Cote Basque
city: Beauvais
country: France
facility: C.H.G. Beauvais
city: Belfort
country: France
facility: Centre Hospitalier General
city: Bordeaux
country: France
facility: Institut Bergonie
city: Bordeaux
country: France
facility: Clinique Tivoli
city: Boucher
country: France
facility: Polyclinique Bordeaux Nord Aquitaine
city: Boulogne Sur Mer
country: France
facility: Centre Hospitalier Docteur Duchenne
city: Bourg En Bresse
country: France
facility: Centre Hospitalier de Fleyriat
city: Bourges
country: France
facility: Centre Hospitalier Jacques-Coeur
city: Brest
country: France
facility: CHU Hopital A. Morvan
city: Brive
country: France
facility: Centre Hospitalier General
city: Caen
country: France
facility: Polyclinique Du Parc Centre Maurice Tubiana
city: Caen
country: France
facility: Centre Regional Francois Baclesse
city: Chambery
country: France
facility: Centre Hospitalier Regional de Chambery
city: Champigny-Sur-Marne
country: France
facility: Clinique Prive Paul d'Egine
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Colmar
country: France
facility: Hopital Louis Pasteur
city: Cornebarrieu
country: France
facility: Clinique des Cedres
city: Dijon
country: France
facility: Centre de Lutte Contre le Cancer Georges-Francois Leclerc
city: Draguignan
country: France
facility: Centre Hospitalier Draguignan
city: Grenoble
country: France
facility: CHU de Grenoble - Hopital de la Tronche
city: Grenoble
country: France
facility: Institut Prive de Cancerologie
city: La Roche Sur Yon
country: France
facility: Centre Hospitalier Departemental
city: Lagny Sur Marne
country: France
facility: Centre Hospitalier de Lagny
city: Le Chesnay
country: France
facility: Hopital Andre Mignot
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lorient
country: France
facility: Centre Hospitalier Bretagne Sud
city: Lyon
country: France
facility: Hopital Hotel Dieu
city: Lyon
country: France
facility: Hopital de la Croix Rousse
city: Lyon
country: France
facility: Centre Leon Berard
city: Lyon
country: France
facility: Hopital Edouard Herriot
city: Mareuil Les Meaux
country: France
facility: Centre de Radiotherapie et Oncologie Saint-Faron
city: Marseille
country: France
facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
city: Metz
country: France
facility: Hopital Notre-Dame de Bon Secours
city: Montbeliard
country: France
facility: Centre Hospitalier General Andre Boulloche
city: Montfermeil
country: France
facility: Intercommunal Hospital
city: Mougins
country: France
facility: Centre Azureen de Cancerologie
city: Mulhouse
country: France
facility: Centre Hospitalier de Mulhouse
city: Muret
country: France
facility: Clinique D'Occitanie
city: Nantes-Saint-Herblain
country: France
facility: Centre Regional Rene Gauducheau
city: Nantes
country: France
facility: Centre Catherine de Sienne
city: Narbonne
country: France
facility: Clinique Les Genets
city: Neuilly sur Seine
country: France
facility: Clinique Hartmann
city: Paris
country: France
facility: Hopital Saint Antoine
city: Paris
country: France
facility: Hopital Tenon
city: Pau
country: France
facility: C.H.G. De Pau
city: Perigueux
country: France
facility: Polyclinique Francheville
city: Perpignan
country: France
facility: Clinique Saint - Pierre
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon Sud
city: Poitiers
country: France
facility: CHU Poitiers
city: Quimper
country: France
facility: Centre Hospitalier de Cornouaille
city: Rennes
country: France
facility: Centre Eugene Marquis
city: Roanne
country: France
facility: CHG Roanne
city: Rodez
country: France
facility: Centre Hospitalier de Rodez
city: Saint Brieuc
country: France
facility: Clinique Armoricaine De Radiologie
city: Saint Cloud
country: France
facility: Centre Rene Huguenin
city: Strasbourg
country: France
facility: Centre Paul Strauss
city: Suresnes
country: France
facility: Centre Medico-Chirurgical Foch
city: Tarbes
country: France
facility: Polyclinique de L'Ormeau
city: Toulouse
country: France
facility: Institut Claudius Regaud
city: Toulouse
country: France
facility: Clinique Pasteur
city: Toulouse
country: France
facility: Clinique Du Parc
city: Toulouse
country: France
facility: Clinique du Chateau
city: Toulouse
country: France
facility: Hopital J. Ducuing
city: Vandoeuvre-les-Nancy
country: France
facility: Centre Alexis Vautrin
Study officials:
affiliation: Centre Eugene Marquis
name: Pierre Kerbrat, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.