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Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer Clinical research trials and Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer. Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer clinical trial. Participants typically obtain the most effective healthcare available for their Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer  Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer
Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer
For Condition: stage 3A breast cancer,stage 2 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. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of chemotherapy plus radiation therapy with or without trastuzumab is more effective in treating breast cancer. PURPOSE: Randomizedphase III trial to compare two different chemotherapy regimens plus radiation therapy with or without trastuzumab in treating women who have breast cancer that has spread to lymph nodes in the axilla (under the arm).
Details: OBJECTIVES: - Compare the efficacy of adjuvant cyclophosphamide, epirubicin, and fluorouracil vs adjuvant docetaxel and epirubicin, in terms of 5-year survival without relapse, in women with nonmetastatic adenocarcinoma of the breast with lymph node invasion. - Determine survival of patients treated with these regimens. - Compare the tolerability of trastuzumab (Herceptin) in patients treated with these regimens. - Determine the efficacy and tolerability of trastuzumab in patients with hormone receptor-positive tumors. - Evaluate the quality of life of patients treated with these regimens. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center. Patients are treated in 2 parts. - Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive fluorouracil IV, or epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 3 weeks for 6 courses. Patients then undergo radiotherapy 5 days a week for 5 weeks. - Arm II: Patients receive epirubicin IV over 10 minutes and docetaxel IV over 1 hour on day 1. Treatment repeats every 3 weeks for 6 courses. Patients then undergo radiotherapy as in arm I. Patients with HER2/neu-positive tumors then proceed to part II. Patients with HER2/neu-negative tumors receive no further treatment. Patients with hormone (estrogen or progesterone) receptor-positive tumors also receive oral tamoxifen daily beginning after chemotherapy is completed and continuing for 5 years. - Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive trastuzumab (Herceptin) IV over 30-90 minutes every 3 weeks for 1 year. - Arm II: Patients are followed without treatment. Patients not receiving trastuzumab are followed at 4 months, 6 months, every 4 months for 1 year, and then every 6 months for 3 years. Patients receiving trastuzumab are followed at 4 months and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 2,600 patients will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/64 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed nonmetastatic, unilateral adenocarcinoma of the breast - Axillary lymph node invasion (N1, N2, or N3) - No cutaneous invasion - No T4a or greater disease - No clinically or radiologically suspected metastases - No clinically or radiologically suspected contralateral lesion - No deeply adherent or inflammatory disease - Complete surgical resection performed, including removal of at least 5 lymph nodes, and with no residual tumor, within the past 42 days - No prior breast cancer - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age - 18 to 64 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 - ALT and AST no greater than 1.5 times upper limit of normal (ULN) - Alkaline phosphatase no greater than 2.5 times ULN - Bilirubin no greater than ULN - Hepatitis B and hepatitis C negative - No hepatic dysfunction Renal - Creatinine less than 1.3 mg/dL OR - Creatinine clearance greater than 60 mL/min Cardiovascular - ECHO normal - LVEF at least 50% Pulmonary - FEV normal - No dyspnea at rest - No supplemental oxygen dependence Other - Not pregnant - Fertile patients must use effective contraception - HIV negative - No active infection - No other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix - No contraindication to anthracycline therapy - No chronic medical or psychological condition - No geographic or social reason that would preclude study therapy PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - At least 4 weeks since prior chemotherapy - No other concurrent chemotherapy - No contraindication to anthracycline therapy Endocrine therapy - No prior hormonal therapy Radiotherapy - No prior radiotherapy Surgery - See Disease Characteristics Other - At least 4 weeks since prior experimental therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MarcSpielmann, Study Chair, Institut Gustave Roussy
C.H. General Andre Boulloche *Recruiting*
Montbeliard, , 25209
France
Recruiting A. Monnier 03 81 31 35 54
Clinique Sainte Clotilde *Recruiting*
Sainte Clotilde, , 97492
France
Recruiting Regis Soleilhac 02 62 48 20 40
Institut Bergonie *Recruiting*
Bordeaux, , 33076
France
Recruiting Louis Mauriac 05 56 33 35 35
Institut Claudius Regaud *Recruiting*
Toulouse, , 31052
France
Recruiting Henri Roche 05 61 42 64
CMC Les Ormeaux *Recruiting*
Le Havre, , 76600
France
Recruiting Gilles Piot 02 32 74 33 62
C.H. Bourg En Bresse *Recruiting*
Bourg-en-Bresse, , 01012
France
Recruiting Hubert Orfeuvre 04 74 45 43 38
Institut Jean Godinot *Recruiting*
Reims, , 51056
France
Recruiting Jean Eymard 03 26 50 43 92
Hopital Andre Mignot *Recruiting*
Le Chesnay, , 78157
France
Recruiting Didier Mayeur 01 39 63 89 09
Centre Hospitalier de Lagny *Recruiting*
Lagny Sur Marne, , 77405
France
Recruiting Annie Bellaiche 01 64 30 70 48
Institut J. Paoli and I. Calmettes *Recruiting*
Marseille, , 13273
France
Recruiting Patrice Viens 33-4-91-223-537
Clinique Saint - Pierre *Recruiting*
Perpignan, ,
France
Recruiting Daniel Castera 04 68 34 01 42
Institut Gustave Roussy *Recruiting*
Villejuif, , F-94805
France
Recruiting Marc Spielmann 33-1-42-11-43-35
Centre Regional Francois Baclesse *Recruiting*
Caen, , 14076
France
Recruiting Thierry Delozier 02 31 45 50 15
Institut Prive de Cancerologie *Recruiting*
Grenoble, , 38100
France
Recruiting D. Assouline 04 76 33 55 50
Clinique du Petit Colmouilins *Recruiting*
Harfleur, , 76700
France
Recruiting Angel Moran 02 35 55 69 10
Hopital Intercommunal De Creteil *Recruiting*
Creteil, , 94010
France
Recruiting Michel Martin 01 45 17 52 10
Hopital Avicenne *Recruiting*
Paris, , 75674
France
Recruiting Loic Guillevin 01 48 95 54 55
Centre Jean Perrin *Recruiting*
Clermont-Ferrand, , 63011
France
Recruiting Philippe Chollet 04 73 27 80 80
Centre Hospitalier de Mulhouse *Recruiting*
Mulhouse, , 68051
France
Recruiting Magali Edel 03 89 64 75 21
Centre Paul Strauss *Recruiting*
Strasbourg, , 67065
France
Recruiting Thierry Petit 03 88 25 24 56
CHU Poitiers *Recruiting*
Poitiers, , 86021
France
Recruiting Hugues Bourgeois 05 49 44 45 38
Centre Hospitalier Regional Metz Thionville *Recruiting*
Metz, , 57038
France
Recruiting Christian Platini 03 87 55 35 54
Centre Paul Papin *Recruiting*
Angers, , 49036
France
Recruiting Alain Lortholary 02 41 35 27 00
Centre Hospitalier d'Annecy *Recruiting*
Annecy, , 74011 Cedex
France
Recruiting Jean Datchary 04 50 88 33 50
Centre Eugene Marquis *Recruiting*
Rennes, , 35042
France
Recruiting Pierre Kerbrat 02 99 25 32 80
Centre de Lutte Contre le Cancer, Georges-Francois Leclerc *Recruiting*
Dijon, , 21079
France
Recruiting Bruno Coudert 03 80 73 75 06
Hopitaux Universitaire de Strasbourg *Recruiting*
Strasbourg, , 67091
France
Recruiting Jean-Pierre Bergerat 03 88 11 62 20
Centre Regional Rene Gauducheau *Recruiting*
Nantes-Saint Herblain, , 44805
France
Recruiting Pierre Fumoleau 02 40 67 91 71
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle *Recruiting*
Montpellier, , 34298
France
Recruiting Gilles Romieu 04 67 61 31 51
Additional Information:
Study ID Numbers: CDR0000269909; FRE-FNCLCC-PACS-04/0005,EU-20236
Study Start Date:
Record last reviewed: January 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00054587
Other Stage 3a Breast Cancer Studies:
1. Trastuzumab and Chemotherapy Followed by Surgery and Combination Chemotherapy in Treating Women With Locally Advanced Breast Cancer
2. Combination Chemotherapy in Treating Women With Stage II or Stage III Breast Cancer
3. Edotecarin in Treating Women With Locally Advanced or Metastatic Breast Cancer That Has Not Responded to Anthracycline and Taxane Chemotherapy
4. Breast-Conserving Therapy Compared With Mastectomy Followed By Radiation Therapy in Treating Women With Locally Advanced Breast Cancer Previously Treated With Chemotherapy
5. Docetaxel or Paclitaxel in Treating Women With Unresectable Locally Advanced or Metastatic Breast Cancer
Related Studies:
Other stage 3A breast cancer Clinical Trials
Other Clinical Trials
Other Nantes-Saint Herblain Clinical Trials
Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer
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