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Combination Chemotherapy in Treating Women With Stage I Breast Cancer
This study has been completed.
Sponsor:
UNICANCER
Information provided by (Responsible Party):
UNICANCER
ClinicalTrials.gov Identifier:
NCT00055679
First received: March 6, 2003
Last updated: June 17, 2013
Last verified: June 2013
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Breast Cancer | Drug: cyclophosphamide Drug: epirubicin hydrochloride Drug: fluorouracil | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase III Randomized Study Of Adjuvant Fluourouracil, Epirubicin And Cyclophosphamide, In Women With Stage I Breast Cancer |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
MedlinePlus related topics:
Breast Cancer
U.S. FDA Resources
Further study details as provided by UNICANCER:
Primary Outcome Measures:
- Efficacy, in terms of 5-year survival [ Time Frame: 5 years from randomization ]
Secondary Outcome Measures:
- Event free survival [ Time Frame: 5 years from randomization ]
- Toxicity [ Time Frame: 5 years from randomization ]
- Biological factors significant for prognosis and prediction of survival [ Time Frame: 5 years from randomization ]
| Enrollment: | 1512 |
| Study Start Date: | August 2002 |
| Study Completion Date: | June 2013 |
| Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 |
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| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00055679
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00055679
Hide Study 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
| 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 |
| Study First Received: | March 6, 2003 |
| Last Updated: | June 17, 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 |
ClinicalTrials.gov processed this record on June 26, 2017