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Combination Chemotherapy After Surgery in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Combination Chemotherapy After Surgery in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Combination Chemotherapy After Surgery in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer Clinical research trials and Combination Chemotherapy After Surgery in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Combination Chemotherapy After Surgery in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer. Combination Chemotherapy After Surgery in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Combination Chemotherapy After Surgery in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer clinical trial. Subjects typically recieve the finest healthcare available for their Combination Chemotherapy After Surgery in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy After Surgery in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer  Combination Chemotherapy After Surgery in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer
Combination Chemotherapy After Surgery in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer
For Condition: stage 3B breast cancer,stage 1 breast cancer,stage 2 breast cancer,stage 3C breast cancer,stage 3A breast cancer
Status: Recruiting
Sponsor(s): International Breast Cancer Study Group ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapyregimen is more effective after surgery in treating breast cancer. PURPOSE: Randomizedphase III trial to compare different combination chemotherapy regimens in treating patients who have stage I, stage II, or stage III breast cancer.
Details: OBJECTIVES: - Determine the efficacy of adjuvant induction chemotherapy with or without cyclophosphamide and methotrexate as maintenance chemotherapy in patients with stage I, II, or III breast cancer. - Compare the disease-free survival, overall survival, and systemic disease-free survival of patients treated with these regimens. - Compare the toxic effects of these regimens in these patients. - Compare 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, menopausal status (pre vs post), and induction chemotherapy (doxorubicin and cyclophosphamide vs other agents). Patients are randomized to one of two treatment arms. - Patients receive one of the following adjuvant induction chemotherapy regimens: - AC comprising doxorubicin and cyclophosphamide IV on day 1 every 21 days for 4 courses - EC comprising epirubicin and cyclophosphamide IV on day 1 every 21 days for 4 courses - CMF comprising oral cyclophosphamide once daily on days 1-14 and methotrexate and fluorouracil IV on days 1 and 8 every 28 days for 6 courses - AC OR EC for 4 courses followed by CMF for 3 courses - CEF comprising oral cyclophosphamide once daily on days 1-14 and epirubicin and fluorouracil IV on days 1 and 8 every 28 days for 6 courses - CAF comprising oral cyclophosphamide once daily on days 1-14 and doxorubicin and fluorouracil IV on days 1 and 8 every 28 days for 6 courses - Arm II: Patients receive adjuvant induction chemotherapy as in arm I. Beginning 28 days after the completion of induction chemotherapy, patients receive maintenance chemotherapy comprising oral cyclophosphamide once daily and oral methotrexate two times a day twice weekly for 1 year. Patients with breast-conserving surgery receive radiotherapy following completion of induction chemotherapy. Quality of life is assessed at baseline, at the beginning of each course of induction chemotherapy, and at months 6, 12, 18, 24, 36, 48, 60, and 72. Patients are followed every 6 months for 5 years and then annually thereafter. PROJECTED ACCRUAL: Approximately 1,330 patients will be accrued for this study within 5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed stage I, II, or III breast cancer - T1-3, N0-1, M0 - T4 disease with minimal dermal invasion allowed - No T4 disease with ulceration of skin, infiltration of skin (except pathologically minimal dermal involvement), peau d'orange, or inflammatory breast cancer - No bilateral breast cancer (except in situ carcinoma) or suspicious mass in opposite breast that has not been proven benign - No distant metastases - No skeletal pain of unknown cause, elevated alkaline phosphatase, or bone scan showing hot spots that cannot be ruled out as metastases by x-ray, MRI, and/or CT - Prior total mastectomy OR breast-conserving procedure (e.g., lumpectomy, quadrantectomy, or partial mastectomy with negative margins) within past 6 weeks - Negative surgical margins - Axillary clearance with at least 8 lymph nodes examined OR - Negative sentinel node biopsy OR - Positive lymph nodes and unsuitable for taxane-based chemotherapy - Hormone receptor status: - Estrogen and progesterone receptor negative - Less than 10% positive tumor cells by immunohistochemistry PATIENT CHARACTERISTICS: Age: - Not specified Sex: - Not specified Menopausal status: - Premenopausal, defined as less than 6 months since last menstrual period (LMP) AND no prior bilateral ovariectomy AND not on estrogen replacement (OR under age 50) OR - Postmenopausal, defined as prior bilateral ovariectomy OR more than 12 months since LMP without prior hysterectomy (OR age 50 and over) Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - WBC greater than 4,000/mm3 - Platelet count greater than 100,000/mm3 Hepatic: - See Disease Characteristics - Bilirubin less than 1.17 mg/dL - ALT less than 1.5 times upper limit of normal OR - AST less than 60 IU/L Renal: - Creatinine less than 1.36 mg/dL Other: - Not pregnant or lactating within the past 6 months - Fertile patients must use effective barrier contraception - No other prior or concurrent malignancy except adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or contralateral or ipsilateral in situ breast carcinoma - No psychiatric or addictive disorders that would preclude study - No non-malignant systemic disease that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - See Disease Characteristics - No prior adjuvant or neoadjuvant chemotherapy for breast cancer Endocrine therapy: - No prior endocrine therapy for breast cancer - No prior tamoxifen or raloxifene for breast cancer Radiotherapy: - No prior radiotherapy for breast cancer Surgery: - See Disease Characteristics Other: - No prior preventative therapy for breast cancer
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MarcoColleoni, Study Chair, European Institute of Oncology
Ashford Cancer Centre *Recruiting*
Ashford, South Australia, 5035
Australia
Recruiting Dusan Kotasek 61-8-351-0211
Townsville General Hospital *Recruiting*
Townsville, Queensland, 4810
Australia
Recruiting P Donnelly 61-7-4796-1634
Institute of Oncology at Prince of Wales Hospital *Recruiting*
Randwick, New South Wales, 2031
Australia
Recruiting Michael Friedlander 61-2-9382-2606
Centre Hospitalier Universitaire Vaudois *Recruiting*
Lausanne, , CH-1011
Switzerland
Recruiting Lucien Perey 41-21-314-041-68
Groote Schuur Hospital *Recruiting*
Cape Town, , 7925
South Africa
Recruiting E Murray 021 4044267
Royal Melbourne Hospital *Recruiting*
Parkville, Victoria, 3050
Australia
Recruiting John Collins 61-3-9349-4688
Ospedale B. Ramazzini *Recruiting*
Carpi, , 41012
Italy
Recruiting Fabrizio Artioli 39-059-659-313
Dunedin Hospital *Recruiting*
Dunedin, ,
New Zealand
Recruiting David Perez 03-474-7947
Liverpool Hospital *Recruiting*
Liverpool, New South Wales, 2170
Australia
Recruiting Eugene Moylan 61-2-9828-5283
Newcastle Mater Misericordiae Hospital *Recruiting*
Waratah, New South Wales, 2298
Australia
Recruiting John Forbes 61-2-4985-0113
Ospedale Sant' Eugenio *Recruiting*
Rome, , 00144
Italy
Recruiting Mauro Antimi 39-06-5100-2569
Sahlgrenska University Hospital *Recruiting*
Gothenburg (Goteborg), , S-413 45
Sweden
Recruiting S.B. Holmberg 46-31-342-22-44
Peter MacCallum Cancer Centre *Recruiting*
East Melbourne, Victoria, 3002
Australia
Recruiting Guy Toner 61-3-9656-1111
Instituto de Enfermedades Neoplasicas *Recruiting*
Lima, , 34
Peru
Recruiting Henry Gomez 511 271 1143
Sandton Oncology Centre *Recruiting*
Johannesburg, , 2121
South Africa
Recruiting Daniel Vorobiof 27-11-8830900
Spedali Civili *Recruiting*
Brescia, , 25124
Italy
Recruiting Edda Simoncini 39-030-39-951
Russian Academy of Medical Sciences Cancer Research Center *Recruiting*
Moscow, , 115478
Russian Federation
Recruiting K.P. Laktionov 7-095-324-2224
Instituto de Radiomedicina *Recruiting*
Santiago, , 34
Chile
Recruiting Rodrigo Arriagada 56-2-754-1700
National Institute of Oncology *Recruiting*
Budapest, , 1125
Hungary
Recruiting Istvan Lang 36-1-22-48-763
St. Vincent's Hospital *Recruiting*
Fitzroy, Victoria, 3065
Australia
Recruiting Raymond Snyder 61-3-9288-3155
Austin Hospital *Recruiting*
Heidelberg, Victoria, 3084
Australia
Recruiting Mitchell Chipman 61-3-9457-6933
King's College Hospital *Recruiting*
London, England, SE5 9RS
United Kingdom
Recruiting Paul Ellis 44-207-346-4849
Beatson Oncology Centre *Recruiting*
Glasgow, Scotland, G11 6NT
United Kingdom
Recruiting A Rodger 44-141-211-2548
Canberra Hospital *Recruiting*
Garran, , 2605
Australia
Recruiting Paul Craft 61-2-6244-2220
European Institute of Oncology *Recruiting*
Milano, , 20141
Italy
Recruiting Marco Colleoni 39-2-574-89439
Institut Central des Hopitaux Valaisans *Recruiting*
Sion, , CH1951
Switzerland
Recruiting Reto Obrist 41-27-603-4786
Ospedale Generale Gorizia *Recruiting*
Gorizia, , 34170
Italy
Recruiting Silva Foladore 39-0481-592-295
Frankston Hospital *Recruiting*
Frankston, Victoria, 3199
Australia
Recruiting Vinod Ganju 61-3-9784-7777
Istituto Oncologico della Svizzera Italiana *Recruiting*
Lugano, , CH-6900
Switzerland
Recruiting Aron Goldhirsch 41-91-811-6111
Box Hill Hospital *Recruiting*
Box Hill, Victoria, 3128
Australia
Recruiting J. Chirgwin 61-3-9897-4688
Mater Public Hospital *Recruiting*
South Brisbane, Queensland, 4101
Australia
Recruiting Kerry Taylor 61-7-3840-8943
Launceston General Hospital *Recruiting*
Launceston, Tasmania, 7250
Australia
Recruiting David Boadle 61-3-327-111
Fremantle Hospital *Recruiting*
Fremantle, Western Australia, 6160
Australia
Recruiting A Davidson 0894312580
Hopital des Cadolles, Neuchatel *Recruiting*
Neuchatel, , 2000
Switzerland
Recruiting D. Piguet 0041 32 722 9464
Institute of Oncology, Ljubljana *Recruiting*
LJUBLJANA, , Sl-1000
Slovenia
Recruiting J. Lindtner 386-1-431-4225
Royal Perth Hospital *Recruiting*
Perth, Western Australia, 6000
Australia
Recruiting David Ranson 61-8-9224-2334
Caboolture Hospital *Recruiting*
Caboolture, Queensland, 4510
Australia
Recruiting W. Premaratne 61-7-5433-8846
Ospedale degli Infermi - ASL 12 *Recruiting*
Biella, , 13900
Italy
Recruiting Mario Clerico 39-015-350-3705
Princess Alexandra Hospital *Recruiting*
Brisbane, Queensland, 4102
Australia
Recruiting Euan Walpole 61-7-3240-2555
Hospital Universitario 12 de Octubre *Recruiting*
Madrid, , 28041
Spain
Recruiting Hernan Cortes-Funes 3491-390-8349
Murray Valley Private Hospital *Recruiting*
Wodonga, Victoria, 3690
Australia
Recruiting Craig Underhill 61-2-6055-3200
Hopital Cantonal Universitaire de Geneve *Recruiting*
Geneva, , CH-1211
Switzerland
Recruiting Herve Bonnefoi 41-22-382-3311
Ospedali Riuniti di Bergamo *Recruiting*
Bergamo, , 24100
Italy
Recruiting Carlo Tondini 39-035-269-859 ext. 931
Auckland Hospital *Recruiting*
Auckland, , 1
New Zealand
Recruiting Vernon Harvey 9-3797440
Westmead Hospital *Recruiting*
Westmead, New South Wales, 2145
Australia
Recruiting P. Harnett 61-2-9845-6954
Queensland Radium Institute *Recruiting*
Brisbane, Queensland, 4029
Australia
Recruiting Simon Durrant 61-7-3636-8756
Oesterreichisches Forum Gegen Krebs *Recruiting*
Porto Alegre, Rio Grande do Sul, 90035-003
Brazil
Recruiting C. Menke 55-51-3316-8849
Sunnybrook and Women's College Health Sciences Centre *Recruiting*
Toronto, Ontario, M4N 3M5
Canada
Recruiting Kathleen Pritchard 416-480-4616
Queen Elizabeth Hospital *Recruiting*
Adelaide, South Australia, 5011
Australia
Recruiting K Patterson 61-8-8222-6847
Royal North Shore Hospital *Recruiting*
St. Leonards, New South Wales, 2065
Australia
Recruiting Helen Wheeler 61-2-9926-7184
Andrew Love Cancer Centre *Recruiting*
Geelong, Victoria, 3220
Australia
Recruiting R. McLennan 61-3-5226-7855
Royal Hospital for Women *Recruiting*
Randwick, New South Wales, 2031
Australia
Recruiting J Eden 61 2 9382 6777
Ospedale Civile Rimini *Recruiting*
Rimini, , 47900
Italy
Recruiting Alberto Ravaioli 39-0541-705-409
Cabrini Hospital *Recruiting*
Malvern, Victoria, 3144
Australia
Recruiting Gary Richardson 61-3-9509-6988
Landeskrankenhaus/Universitatskliniken Graz *Recruiting*
Graz, , A-8036
Austria
Recruiting Irene Thiel 43-0316-385-3129
Ospedale San Giovanni *Recruiting*
Bellinzona, , CH-6500
Switzerland
Recruiting Franco Cavalli 41-91-250-333
Port Mcquarie Base Hospital *Recruiting*
Port Macquarie, New South Wales, 2444
Australia
Recruiting Stephen Begbie 61-2-6580-1116
Universitatsklinken Basel *Recruiting*
Basel, , CH-4031
Switzerland
Recruiting Richard Herrmann 41-61-265-5075
Sir Charles Gairdner Hospital - Perth *Recruiting*
Perth, Western Australia, 6009
Australia
Recruiting Michael Byrne 61-8-9346-3841
Petrov Research Institute of Oncology *Recruiting*
Saint Petersburg, , 197758
Russian Federation
Recruiting V.F. Semiglazov 812-596-89-18
Royal Hobart Hospital *Recruiting*
Hobart, Tasmania, 7000
Australia
Recruiting Raymond Lowenthal + 61-3-6222-8157
Kantonspital Aarau *Recruiting*
AARAU, , 5001
Switzerland
Recruiting Astrid Schonenberger 0041-62-838-60-53
Mount Medical Centre *Recruiting*
Perth, Western Australia, 6000
Australia
Recruiting Guy Van Hazel 61-8-9481-2118
Tampere University School of Medicine *Recruiting*
Tampere, , FIN-33014
Finland
Recruiting Holli Kaija 358-3-3116-4524
Waikato Hospital *Recruiting*
Hamilton, , 2020
New Zealand
Recruiting Ian Campbell 64-7864-3665
Ospedale San Bortolo *Recruiting*
Vicenza, , 36100
Italy
Recruiting M. Magazu 39-0444-993-906
Inselspital, Bern *Recruiting*
Bern, , CH-3010
Switzerland
Recruiting Martin Fey 41-31-632-2243
Christchurch Hospital *Recruiting*
Christchurch, , 1
New Zealand
Recruiting Grahame Jeffery 643-364-0020
Palmerston North Hospital *Recruiting*
Palmerston North, ,
New Zealand
Recruiting Simon Allan 06-356-9169
National Cancer Centre - Singapore *Recruiting*
Singapore, , 169610
Singapore
Recruiting Karmen Wong 65-436-8000
Ratisches Kantons und Regionalspital *Recruiting*
Chur, , CH-7000
Switzerland
Recruiting Fritz Egli 41-81-256-6111
Kantonsspital - St. Gallen *Recruiting*
St. Gallen, , CH-9007
Switzerland
Recruiting Thomas Cerny 41-71-494-1062
St. George Hospital *Recruiting*
Sydney, New South Wales, 2217
Australia
Recruiting Paul Souza 61-2-9350-3910
Centro di Riferimento Oncologico - Aviano *Recruiting*
Aviano, , 33081
Italy
Recruiting Andrea Veronesi 636-434-659-653
Dubbo Base Hospital *Recruiting*
Dubbo, New South Wales, 2830
Australia
Recruiting J. Beith 61-2-6882-2333
Wesley Medical Centre *Recruiting*
Auchenflower, Queensland, 4066
Australia
Recruiting C. Furnival 61-7-3870-4422
Additional Information:
Study ID Numbers: CDR0000068827; EU-20119,IBCSG-22-00
Study Start Date:
Record last reviewed: August 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00022516
Other Stage 3a Breast Cancer Studies:
1. Correlation of Menstrual Cycle Phase at Time of Primary Surgery With 5-Year Disease-Free Survival in Women With Stage I or Stage II Breast Cancer
2. Ductal Lavage in Assessing Women With Early Breast Cancer or at High Risk of Developing Breast Cancer Who Are Eligible For Tamoxifen Therapy
3. Vaccine Therapy in Treating Patients With Breast Cancer
4. Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer
5. Comparison of Three Combination Chemotherapy Regimens in Treating Women With Stage I or Stage II Breast Cancer
Related Studies:
Other stage 3A breast cancer Clinical Trials
Other Victoria Clinical Trials
Other East Melbourne Clinical Trials
Combination Chemotherapy After Surgery in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer
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