Combination Chemotherapy in Treating Women With Stage I Breast Cancer

• ClinicalTrials.gov Identifier: NCT00055679
• Recruitment Status: Completed
• First Posted: March 7, 2003
• Last Update Posted: June 18, 2013
• Sponsor: UNICANCER
• Information provided by (Responsible Party): UNICANCER

Study Description

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

• 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

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

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

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older 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

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

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
• 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