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Clinical Trial: Combination Chemotherapy in Treating Women With Stage I Breast Cancer
This study is currently recruiting patients.
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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 | Treatment or Intervention | Phase |
|---|---|---|
| stage I breast cancer | Drug: cyclophosphamide Drug: epirubicin Drug: fluorouracil Drug: tamoxifen Procedure: adjuvant therapy Procedure: antiestrogen therapy Procedure: chemotherapy Procedure: endocrine therapy Procedure: hormone therapy Procedure: radiation therapy | Phase III |
MedlinePlus related topics: Breast Cancer
Genetics Home Reference related topics: breast cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase III Randomized Study of Adjuvant Fluorouracil, Epirubicin, and Cyclophosphamide in Women With Stage I Breast Cancer
Further Study Details:
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 - 65 Years, Genders Eligible for Study: Both
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
Location and Contact Information
France
C.H.G. Beauvais, Beauvais, 60021, France; Recruiting
J.L. Dutel, MD 33-344-112-309 jl.dutel@ch_beauvais.fr
C.H.G. De Pau, Pau, 64046 Universite Cedex, France; Recruiting
Maxime Malet, MD 33-5-59-72-67-96
Centre Alexis Vautrin, Vandoeuvre-les-Nancy, 54511, France; Recruiting
Maria Rios, MD 33-3-8359-8461 m.rios@nancy.fnclcc.fr
Centre Antoine Lacassagne, Nice, 06189, France; Recruiting
Moise Namer, MD 33-93-492-031-351 moise.namer@wanadoo.fr
Centre Catherine de Sienne, Nantes, 02, France; Recruiting
Alain Lortholary, MD 33-40-02-28-272-000
Centre de Lutte Contre le Cancer Georges-Francois Leclerc, Dijon, 21079, France; Recruiting
Francoise Mayer 33-03-8073-7528
Centre de Radiotherapie et Oncologie Saint-Faron, Mareuil-les-Meaux, 77100, France; Recruiting
Jacques Mandet, MD 33-16-43-34-848 jacques.mandet@wanadoo.fr
Centre Eugene Marquis, Rennes, 35042, France; Recruiting
Pierre Kerbrat, MD, PhD 33-299-253-280 kerbrat@rennes.fnclcc.fr
Centre Hospital General Robert Ballanger, Aulnay-sous-Bois, 93602, France; Recruiting
Claude Boiron, MD 33-1-4936-7123
Centre Hospitalier Bretagne Sud, Lorient, 56322, France; Recruiting
Marie-Josephe Foucher-Goudier 33-02-9764-9193
Centre Hospitalier d'Annecy, Annecy, 74011 Cedex, France; Recruiting
Jocelyne Provencal, MD 33-50-88-33-28 jprovencal@ch-annecy.fr
Centre Hospitalier d'Auxerre, Auxerre, 89011, France; Recruiting
Isabelle Cauvin 33-03-8648-4848
Centre Hospitalier de Cornouaille, Quimper, 29107, France; Recruiting
Dominique Besson 33-02-9852-6060
Centre Hospitalier de Fleyriat, Bourg-en-Bresse, 01012, France; Recruiting
Hubert Orfeuvre, MD 33-04-7445-43-38 horfeuvre@ch-bourgo1.fr
Centre Hospitalier de la Cote Basque, Bayonne, 64100, France; Recruiting
Stephane Remy 33-05-5944-3535
Centre Hospitalier de Lagny, Lagny Sur Marne, 77405, France; Recruiting
Annie Bellaiche, MD 33-01-6430-7048
Centre Hospitalier de Mulhouse, Mulhouse, 68051, France; Recruiting
Anne-Marie Elgard 33-3-8964-6464
Centre Hospitalier de Rodez, Rodez, 12027, France; Recruiting
Alain Maare 33-05-6575-1760
Centre Hospitalier Departemental, La Roche-sur-Yon, 85025, France; Recruiting
Franck Priou 33-02-5144-6161 frank.priou@chd-vendee.fr
Centre Hospitalier Docteur Duchenne, Boulogne-sur-Mer, 62200, France; Recruiting
Zoher Merad-Boudia 33-3-21-99-3333
Centre Hospitalier Draguignan, Draguignan, 83300, France; Recruiting
Bruno Valenza, MD 33-04-9460-5000 bruno.valenza@ch_draguignan.fr
Centre Hospitalier General Andre Boulloche, Montbeliard, 25209, France; Recruiting
A. Monnier, MD 33-38-131-3515 oncomontbe@infonie.fr
Centre Hospitalier General, Belfort, 90000, France; Recruiting
Gerard Poulin, MD 33-384-574-049 oncobel@club-internet.fr
Centre Hospitalier General, Brive, 19101, France; Recruiting
Bernard Leduc, MD 0555-92-60-00 oncologie@ch-brive.fr
Centre Hospitalier Jacques-Coeur, Bourges, 18016, France; Recruiting
Christine Berger 33-02-4848-4848
Centre Hospitalier Lyon Sud, Pierre-Benite, 69495, France; Recruiting
Gilles Freyer, MD 33-04-7886-3324 gilles.freyer@chu-lyon.fr
Centre Hospitalier Regional de Chambery, Chambery, 73011, France; Recruiting
Cecile Agostini, MD 33-4-79-96-61-81
Centre Hospitalier Victor Dupouy, Argenteuil, 95107, France; Recruiting
Sophie Barthier 33-01-3423-2089
Centre Jean Perrin, Clermont-Ferrand, 63011, France; Recruiting
Herve Cure, MD, PhD 33-4-73-278-139
Centre Leon Berard, Lyon, 69373, France; Recruiting
Pierre Biron, MD 33-78-782-641 biron@lyon.fnclcc.fr
Centre Medico-Chirurgical Foch, Suresnes, 92151, France; Recruiting
Laurent Mignot, MD 33-146-252-168 ext. 2288
Centre Oscar Lambret, Lille, 59020, France; Recruiting
Veronique Servent, MD 33-03-2029-5262
Centre Paul Papin, Angers, 49036, France; Recruiting
Sophie Abadie-Lacourtoisie, MD 33-2-4135-2700
Centre Paul Strauss, Strasbourg, 67065, France; Recruiting
Thierry Petit, MD, PhD 33-3-8825-2424 tpetit@strasbourg.fnclcc.fr
Centre Regional Francois Baclesse, Caen, 14076, France; Recruiting
Thierry Delozier, MD 33-23-145-5015 t.delozier@baclesse.fr
Centre Regional Rene Gauducheau, Nantes-Saint Herblain, 44805, France; Recruiting
Mario Campone 33-02-4067-9977 m-campone@nantes-fnclcc.fr
Centre Rene Huguenin, Saint Cloud, 92211, France; Recruiting
E.G.C. Brain, MD 33-147-111-515 e.brain@stcloud-huguenin.org
CHG Roanne, Roanne, F-42300, France; Recruiting
M.C. Gouttebel, MD, PhD 33-4-77-44-33-96
CHU de Grenoble - Hopital de la Tronche, Grenoble, 38043, France; Recruiting
Mireille Mousseau, MD 33-76-765-451 mmousseau@chu.grenoble.fr
CHU Hopital A. Morvan, Brest, 29609, France; Recruiting
Jean-Paul Labat, MD 0298 22 3395
CHU Poitiers, Poitiers, 86021, France; Recruiting
Hugues Bourgeois, MD 33-05-4944-4538
Clinique Armoricaine De Radiologie, Saint-Brieuc, F-22015, France; Recruiting
Anne-Claire Hardy-Bessard, MD 33-2-96-75-22-16 ac.hardy@clin-armoricaine.fr
Clinique Claude Bernard, Albi, 81000, France; Recruiting
Phillipe Houyau, MD 33-05-6377-7750
Clinique des Cedres, Cornebarrieu, 31700, France; Recruiting
Veronique Fabre, MD 33-5-62-13-32-03
Clinique D'Occitanie, Muret, 31600, France; Recruiting
Marion Montastruc, MD 33-5-61-51-88-92
Clinique du Chateau, Toulouse, 31080, France; Recruiting
Martial Boisseau 33-05-6133-2228 martial.boisseau@laposte.net
Clinique Du Parc, Toulouse, 31078, France; Recruiting
Mathilde Martinez, MD 33-5-61-36-69-38
Clinique Hartmann, Neuilly-sur-Seine, 92200, France; Recruiting
Jean-Michel Vannetzel, MD 33-01-4759-0000
Clinique Les Genets, Narbonne, 11100, France; Recruiting
Andre Mathieu 33-4-68-65-10-52
Clinique Pasteur, Toulouse, 31076, France; Recruiting
Nicolas Albin, MD 33-05-6221-3131
Clinique Prive Paul d'Egine, Champigny-sur-Marne, 94500, France; Recruiting
Jean-Victor Chantelard 33-01-4270-6001
Clinique Saint - Pierre, Perpignan, France; Recruiting
Daniel Castera, MD 33-09-6839-0742
Clinique Tivoli, Bordeaux, F-33000, France; Recruiting
Dominique Jaubert, MD 33-556-116-087 dominique.jaubert@wanadoo.fr
Hopital Andre Mignot, Le Chesnay, 78157, France; Recruiting
Didier Mayeur, MD 33-1-3963-8909 dmayeur@ch_versailles.fr
Hopital de la Croix Rousse, Lyon, 69317, France; Recruiting
Pierre Jousselin de Saint-Hilaire 33-04-7207-1639 pierre.de-saint-hilare@chu-lyon.fr
Hopital Edouard Herriot, Lyon, 69437, France; Recruiting
Jean-Dominique Tigaud 33-472-117-401
Hopital Hotel Dieu, Lyon, 69288, France; Recruiting
Francois Golfier, MD, PhD 33-4-7241-3249 francois.sgolfier@chu-lyon.fr
Hopital J. Ducuing, Toulouse, France; Recruiting
Stephane Aczel, MD 0561 77 3439
Hopital Louis Pasteur, Colmar, 68024, France; Recruiting
Bruno Audhuy, MD 33-03-89-12-4102 bruno.audhuy@ch_colmar.rss.fr
Hopital Notre-Dame de Bon Secours, Metz, 57038, France; Recruiting
Sabine Walter, MD 33-387-553-554 s.walter@chr-metz-thionville.rss.fr
Hopital Saint Antoine, Paris, 75012, France; Recruiting
Christophe Tournigand 33-1-4928-2329 christophe.tournigand@sat.ap-hop-paris.fr
Hopital Tenon, Paris, 75970, France; Recruiting
Jean-Pierre Lotz, MD 33-01-5609-3476 jean-pierre.lotz@tnn.ap-hop-paris.fr
Institut Bergonie, Bordeaux, 33076, France; Recruiting
Louis Mauriac, MD 33-56-333-258 mauriac@bergonie.org
Institut Claudius Regaud, Toulouse, 31052, France; Recruiting
Henri Hubert Roche, MD, PhD 33-5-6142-4129 roche@icr.fnclcc.fr
Institut J. Paoli and I. Calmettes, Marseille, 13273, France; Recruiting
Patrice Viens, MD 33-4-91-223-537 oncomed@marseille.fnclcc.fr
Institut Prive de Cancerologie, Grenoble, 38100, France; Recruiting
D. Assouline, MD 33-76-33-55-50 david.assouline@groupe-du-mail.com
Institut Sainte Catherine, Avignon, 84082, France; Recruiting
Daniel Serin, MD 33-490-276-263 d.serin@institut-ste-catherine.rss.fr
Intercommunal Hospital, Montfermeil, 93370, France; Recruiting
Mostefa Bennamoun, MD 33-1-4850-1808
Polyclinique Bordeaux Nord Aquitaine, Boucher, 33300, France; Recruiting
Nadine Dohollou, MD 33-5-56-43-73-54
Polyclinique de L'Ormeau, Tarbes, 65000, France; Recruiting
Bernard Couderc, MD 33-056-293-5929
Polyclinique Du Parc Centre Maurice Tubiana, Caen, 14052, France; Recruiting
Patrick Allain 33-23-182-8282
Polyclinique Francheville, Perigueux, 24004, France; Recruiting
Charles-Briac Levache, MD 33-553-02-12-93
Study chairs or principal investigators
Pierre Kerbrat, MD, PhD, Study Chair, Centre Eugene Marquis
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Study ID Numbers: CDR0000270763; FRE-FNCLCC-PACS-05/0106; EU-20239; NCT00055679
Record last reviewed: January 2005
Last Updated: April 4, 2005
Record first received: March 6, 2003
ClinicalTrials.gov Identifier: NCT00055679
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Record last reviewed: January 2005
Last Updated: April 4, 2005
Record first received: March 6, 2003
ClinicalTrials.gov Identifier: NCT00055679
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
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