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Home > "C" Clinical Trials Conditions > Combination Chemotherapy Compared With Observation After Surgery in Treating Women With Relapsed Nonmetastatic Breast Cancer  Combination Chemotherapy Compared With Observation After Surgery in Treating Women With Relapsed Nonmetastatic Breast Cancer
Combination Chemotherapy Compared With Observation After Surgery in Treating Women With Relapsed Nonmetastatic Breast Cancer
For Condition: recurrent breast cancer,stage 3A breast cancer,stage 2 breast cancer,stage 1 breast cancer
Status: Recruiting
Sponsor(s): Federation Nationale des Centres de Lutte Contre le Cancer ,
Synopsis: 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, and giving them after surgery, may kill any remaining tumor cells following surgery. It is not yet known whether combination chemotherapy is more effective than observation in treating relapsednonmetastatic breast cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of combination chemotherapy with that of observation in treating women who have undergone surgery for relapsed nonmetastatic breast cancer.
Details: OBJECTIVES: - Compare the efficacy of adjuvant cyclophosphamide, epirubicin, and fluorouracil vs observation, in terms of disease-free 5-year survival, in women who have undergone resection for relapsed nonmetastatic breast cancer after initial conservative surgery. - Compare the overall survival of women treated with these regimens. - Determine the tolerance of these women to the chemotherapy regimen. - Correlate prognostic factors of survival with efficacy of the chemotherapy regimen in these women. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to menopausal status and participating center. Patients are randomized to 1 of 2 treatment arms. Study begins within 42 days after resection of recurrent disease. - Arm I: Patients receive fluorouracil IV over 1 hour, epirubicin IV over 1 hour, and cyclophosphamide IV over 1 hour on day 1. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive docetaxel IV over 1 hour on day 1. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. - Arm II: Patients are examined on days 1 and 63. Patients who are hormone receptor positive also receive one of the following hormonal therapy regimens, depending on menopausal status: - Oral tamoxifen daily for 5 years - Oral tamoxifen daily for 5 years and oral luteinizing hormone-releasing hormone (LHRH) agonist therapy (e.g., goserelin) for 3 years - Oral LHRH agonist therapy (e.g., goserelin) for 3 years - Oral antiaromatase therapy (e.g., anastrozole) for 5 years Patients also undergo radiotherapy and may also undergo second complete resection. Patients are followed every 6 months for 5 years and then annually thereafter. PROJECTED ACCRUAL: A total of 370 patients (185 per treatment arm) will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the breast - No contralateral breast cancer - Local tumor recurrence more than 6 months after conservative surgery - Complete or conservative resection of the recurrent tumor NOTE: Initial complete surgical resection not allowed - No local inflammatory disease or disease that is not amenable to complete surgical resection - No positive axillary lymph nodes - No distant metastases, including subclavicular lymph nodes - Hormone receptor status: - Hormone receptor status known PATIENT CHARACTERISTICS: Age - 18 to 65 Sex - Female Menopausal status - Menopausal status known Performance status - ECOG 0-1 Life expectancy - Not specified Hematopoietic - Neutrophil count at least 2,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than upper limit of normal (ULN) - Transaminases no greater than 1.5 times ULN - Alkaline phosphatase no greater than 2.5 times ULN - No chronic hepatitis B - No active hepatitis C Renal - Not specified Cardiovascular - Cardiac function normal by echocardiogram or isotopes Other - No contraindications to anthracyclines such as any of the following: - Prior doxorubicin over 300 mg/m^2 - Prior epirubicin over 600 mg/m^2 - Prior mitoxantrone over 90 mg/m^2 - No other invasive malignancy - No chronic somatic or psychiatric condition that would preclude study participation - No familial, social, geographic, or psychological reason that would preclude study participation - Not pregnant - Fertile patients must use effective contraception - HIV negative - CA 153 no greater than 2 times ULN PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - See Patient Characteristics-Other - No prior neoadjuvant chemotherapy Endocrine therapy - No prior neoadjuvant hormonal therapy Radiotherapy - No prior neoadjuvant radiotherapy Surgery - See Disease Characteristics - At least 41 days since prior surgery
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GillesRomieu, Study Chair, Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Clinique du Petit Colmouilins *Recruiting*
Harfleur, , 76700
France
Recruiting Angel Moran 0235 55 6910
Centre Hospitalier Compiegne *Recruiting*
Compiegne, , 60321
France
Recruiting D. Zylberait 33-163-44-236-346
Hopital Notre-Dame de Bon Secours *Recruiting*
Metz, , 57038
France
Recruiting Sabine Walter 33-387-553-554
Clinique Saint - Pierre *Recruiting*
Perpignan, ,
France
Recruiting Daniel Castera 33-09-6839-0742
Centre Regional Rene Gauducheau *Recruiting*
Nantes-Saint Herblain, , 44805
France
Recruiting Pierre Fumoleau 0240 679977
Centre Hospitalier de Mulhouse *Recruiting*
Mulhouse, , 68051
France
Recruiting Gilles Prevot 0389 64 7521
CHU Hopital A. Morvan *Recruiting*
Brest, , 29609
France
Recruiting Jean-Paul Labat 0298 22 3395
Centre Jean Perrin *Recruiting*
Clermont-Ferrand, , 63011
France
Recruiting Philippe Chollet 33-04-73-278-198
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle *Recruiting*
Montpellier, , 34298
France
Recruiting Gilles Romieu 04 67 613151
Institut Bergonie *Recruiting*
Bordeaux, , 33076
France
Recruiting Louis Mauriac 33-56-333-258
Clinique Armoricaine De Radiologie *Recruiting*
Saint Brieux, , F-22015
France
Recruiting Anne-Claire Hardy-Bessard 33-2-96-75-22-16
Institut Sainte Catherine *Recruiting*
Avignon, , 84082
France
Recruiting Daniel Serin 33-490-276-263
Institut Gustave Roussy *Recruiting*
Villejuif, , F-94805
France
Recruiting Marc Spielmann 33-1-42-11-43-35
Institut Claudius Regaud *Recruiting*
Toulouse, , 31052
France
Recruiting Laurence Gladieff 56-162-4119
Centre Paul Papin *Recruiting*
Angers, , 49036
France
Recruiting Alain Lortholary 33-2-4135-2700
Centre Hospitalier General *Recruiting*
Brive, , 19101
France
Recruiting Bernard Leduc 0555-92-60-00
Clinique Claude Bernard *Recruiting*
Albi, , 81000
France
Recruiting Phillipe Houyau 33-05-6377-7750
Centre Regional Francois Baclesse *Recruiting*
Caen, , 14076
France
Recruiting Thierry Delozier 33-23-145-5015
C.H. Bourg En Bresse *Recruiting*
Bourg-en-Bresse, , 01012
France
Recruiting Hubert Orfeuvre 33-04-7445-43-38
Centre Eugene Marquis *Recruiting*
Rennes, , 35042
France
Recruiting Pierre Kerbrat 33-299-253-280
Institut J. Paoli and I. Calmettes *Recruiting*
Marseille, , 13273
France
Recruiting Patrice Viens 33-4-91-223-537
C.H. General Andre Boulloche *Recruiting*
Montbeliard, , 25209
France
Recruiting A. Monnier 33-38-131-3515
Polyclinique de L'Ormeau *Recruiting*
Tarbes, , 65000
France
Recruiting Bernard Couderc 33-056-293-5929
Hopital J. Ducuing *Recruiting*
Toulouse, ,
France
Recruiting Stephane Aczel 0561 77 3439
Centre Hospitalier d'Annecy *Recruiting*
Annecy, , 74011 Cedex
France
Recruiting C. Martin 33-50-88-33-28
Centre Oscar Lambret *Recruiting*
Lille, , 59020
France
Recruiting Veronique Servent 33-03-2029-5262
Additional Information:
Study ID Numbers: CDR0000269549; EU-20237,FRE-FNCLCC-PACS-03/003
Study Start Date:
Record last reviewed: January 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00053911
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3. Adjuvant Doxorubicin, Cyclophosphamide, and Paclitaxel in Treating Patients With Breast Cancer
4. Exemestane Compared With Tamoxifen in Treating Postmenopausal Women With Primary Breast Cancer
5. Prognostic Study of Sentinel Lymph Node and Bone Marrow Metastases in Women With Stage I or Stage IIA Breast Cancer
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Combination Chemotherapy Compared With Observation After Surgery in Treating Women With Relapsed Nonmetastatic Breast Cancer
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