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Home > "T" Clinical Trials Conditions > Trastuzumab in Treating Women With Breast Cancer  Trastuzumab in Treating Women With Breast Cancer
Trastuzumab in Treating Women With Breast Cancer
For Condition: stage 2 breast cancer,stage 3A breast cancer,stage 1 breast cancer
Status: Recruiting
Sponsor(s): Breast International Group , EORTC Breast Cancer Cooperative Group,National Cancer Institute of Canada,International Breast Cancer Study Group
Synopsis: RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether trastuzumab is effective in treating breast cancer. PURPOSE: Randomizedphase III trial to determine the effectiveness of trastuzumab in treating women who have breast cancer.
Details: OBJECTIVES: - Compare the disease-free survival of women with HER2-positive primary breast cancer treated with trastuzumab (Herceptin®) for 1 year vs trastuzumab for 2 years vs standard supportive care. - Compare the overall survival of patients treated with these regimens. - Compare the relapse-free survival of patients treated with these regimens. - Compare the distant disease-free survival of patients treated with these regimens. - Compare the incidence of cardiac dysfunction in patients treated with these regimens. - Evaluate the safety and tolerability of these regimens in these patients. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to nodal status (any nodal status and prior neoadjuvant chemotherapy vs no positive nodes and no prior neoadjuvant chemotherapy vs 1-3 positive nodes and no prior neoadjuvant chemotherapy vs 4 or more positive nodes and no prior neoadjuvant chemotherapy), prior adjuvant chemotherapy regimen (no anthracyclines or taxanes vs anthracyclines only vs anthracyclines and taxanes), receptor status and endocrine therapy (negative vs positive and no prior endocrine therapy vs positive and prior endocrine therapy), age (18 to 34 vs 35 to 49 vs 50 to 59 vs 60 and over), and participating center. Patients are randomized to 1 of 3 treatment arms. - Arm I: Patients receive trastuzumab (Herceptin®) IV over 1.5 hours on day 1. Courses repeat every 3 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. - Arm II: Patients receive trastuzumab as in arm I. Courses repeat every 3 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. - Arm III: Patients receive no trastuzumab. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: Approximately 4,482 patients (1,494 per treatment arm) will be accrued for this study within 4 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed nonmetastatic primary invasive adenocarcinoma of the breast - Adequately excised - Axillary nodes positive or negative - No positive or suspicious internal mammary nodes identified by sentinel node technique that have not been irradiated - No supraclavicular lymph node involvement - HER2-positive disease with one of the following: - 3+ overexpression by immunohistochemistry (IHC) - 2+ overexpression by IHC and fluorescence in situ hybridization (FISH) with c-erbB2 gene amplification - c-erbB2 gene amplification by FISH - Previously treated with at least 3 months or 4 courses of approved neoadjuvant or adjuvant chemotherapy with or without radiotherapy - No synchronous bilateral or multifocal breast cancer that is not HER2-positive - No locally advanced or inflammatory breast cancer - No clinical T4 primary breast tumor - Prior curatively treated ipsilateral ductal carcinoma in situ of the breast is allowed - Hormone receptor status: - Estrogen receptor and progesterone receptor status known OR - Estrogen receptor status known PATIENT CHARACTERISTICS: Age - 18 and over Sex - Female Menopausal status - Not specified Performance status - ECOG 0-1 Life expectancy - Not specified Hematopoietic - WBC at least 2,500/mm^3 - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000 Hepatic - Bilirubin no greater than 2 times upper limit of normal (ULN) - AST and ALT no greater than 2.5 times ULN - Alkaline phosphatase no greater than 2.5 times ULN Renal - Creatinine no greater than 2 times ULN Cardiovascular - LVEF at least 55% by echocardiography or MUGA - No serious cardiac illness - No documented congestive heart failure - No high-risk uncontrolled arrhythmias - No angina pectoris requiring antianginal medication - No clinically significant valvular heart disease - No evidence of transmural infarction on EKG - No poorly controlled hypertension (i.e., systolic greater than 180 mm Hg or diastolic greater than 100 mm Hg) Pulmonary - No severe pulmonary disease/illness Other - No other malignancy except for curatively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other cancer that has been curatively treated, with no evidence of disease, and has less than 15% risk of recurrence over the next 10 years - No other concurrent serious disease that would preclude study participation - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective barrier contraception PRIOR CONCURRENT THERAPY: Biologic therapy - No prior peripheral stem cell or bone marrow stem cell transplantation as part of prior neoadjuvant or adjuvant chemotherapy regimen - No prior biologic therapy or immunotherapy for breast cancer - No prior anti-HER2 therapy for any reason - No concurrent immunotherapy for breast cancer Chemotherapy - See Disease Characteristics - See Biologic therapy - No prior cumulative dose of doxorubicin more than 360 mg/m^2 or epirubicin more than 720 mg/m^2 - No prior anthracyclines for another malignancy - No more than 7 weeks since day 1 of last chemotherapy course - No concurrent adjuvant chemotherapy Endocrine therapy - No concurrent hormonal therapy, including aromatase inhibitors, pure antiestrogens, or progestational agents, for breast cancer - Concurrent systemic adjuvant hormonal therapy for estrogen receptor-positive patients allowed - Concurrent tamoxifen allowed Radiotherapy - See Disease Characteristics - No more than 6 weeks since completion of prior radiotherapy - No prior mediastinal irradiation except for internal mammary node irradiation for the present breast cancer Surgery - See Disease Characteristics - No more than 6 weeks since prior definitive surgery - Concurrent ovarian ablation allowed Other - No other concurrent investigational therapy for breast cancer - Concurrent bisphosphonate therapy allowed if started prior to study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
KarenGelmon, Study Chair, British Columbia Cancer Agency
Innsbruck Universitaetsklinik *Recruiting*
Innsbruck, , A-6020
Austria
Recruiting Guenther Gastl 43-512-504-4003
Umea Universitet *Recruiting*
Umea, , 90185
Sweden
Recruiting Nils Bengtsson 46-90-785-0000
Landeskrankenhaus Feldkirch *Recruiting*
Feldkirch-Tisis, , 6807
Austria
Recruiting Alois Lang 43-5522-2300
Northern Centre for Cancer Treatment at Newcastle General Hospital *Recruiting*
Newcastle upon Tyne, England, NE4 6BE
United Kingdom
Recruiting A. Branson 44-191-219-4380
Tuen Mun Hospital *Recruiting*
Hong Kong, ,
China
Recruiting Yuk Tung 852-2468-5087
Saint John of God Hospital *Recruiting*
Geelong, Australian Capital Territory, 3220
Australia
Recruiting Karen White 61-3-5226-7855
Institut Jules Bordet *Recruiting*
Brussels, , B-1000
Belgium
Recruiting Martine Piccart-Gebhart 32-2-5413206
LKH Voecklabruck *Recruiting*
Voecklabruck, , 4840
Austria
Recruiting Ferdinand Haslbauer 43-7672-700
Herning Central Hospital *Recruiting*
Herning, , 7400
Denmark
Recruiting Knud Moeller 45-9927-2727
Bradford Hospitals NHS Trust *Recruiting*
Bradford, England, BD9 6RJ
United Kingdom
Recruiting Chris Bradley 44-1274-542-200
Huddersfield Royal Infirmary *Recruiting*
Huddersfield, West Yorks, England, HD3 3EA
United Kingdom
Recruiting Jonathan Joffe 44-1484-342-150
Allan Blair Cancer Centre *Recruiting*
Regina, Saskatchewan, S4T 7T1
Canada
Recruiting Haji Chalchal 306-766-2691
Hopital Universitaire Erasme *Recruiting*
Brussels, , 1070
Belgium
Recruiting Thierry Velu 32 2 555 4193
Princess Margaret Hospital *Recruiting*
Toronto, Ontario, M5G 2M9
Canada
Recruiting Michael Crump 416-946-4567
Krankenhaus Barmherzige Schwestern *Recruiting*
Linz Donau, , 4010
Austria
Recruiting Ernst Rechberger 43-732-76-770
Centralsygehuset I Naestved *Recruiting*
Naestved, , 4700
Denmark
Recruiting Preben Philip 45-5572-1401
Oncologic Center *Recruiting*
Gliwice, , 44-101
Poland
Recruiting Contact Person 32-8172-0411
CHU Liege - Domaine Universitaire du Sart Tilman *Recruiting*
LIEGE, , B-4000
Belgium
Recruiting Guy Jerusalem 32-4-366-7111
U.Z. Gasthuisberg *Recruiting*
Leuven, , B-3000
Belgium
Recruiting Ignace Vergote 31-16-344635
Medical University of Gdansk *Recruiting*
Gdansk, , 80-211
Poland
Recruiting Contact Person 48-58520-3899
Mount Sinai Hospital - Toronto *Recruiting*
Toronto, Ontario, M5G 1X5
Canada
Recruiting Martin Blackstein 416-586-5371
University Hospital of Linkoping *Recruiting*
Linkoping, , S-581 85
Sweden
Recruiting Bo Nordenskjold 46-13-222-012
Tongji Medical University *Recruiting*
Wuhan, , 430030
China
Recruiting Shi-Ying Yu 86-27-8366-3437
Universita Degli Studi Di Firenze *Recruiting*
Firenze (Florence), , 50121
Italy
Recruiting Contact Person 39-55-411-6083
Saskatoon Cancer Centre *Recruiting*
Saskatoon, Saskatchewan, S7N 4H4
Canada
Recruiting Amer Sami 306-655-2604
Ospedale Beata Vergine *Recruiting*
Mendrisio, , CH-6850
Switzerland
Recruiting Olivia Pagani 41-91-811-3467
Chulalongkorn University Hospital *Recruiting*
Bangkok, , 10330
Thailand
Recruiting Narin Voravud 66-2-256-4533
Landeskrankenanstalten - Salzburg *Recruiting*
Salzburg, , A-5020
Austria
Recruiting Hubert Hausmaninger 43-662-4482-2881
Weston Park Hospital *Recruiting*
Sheffield, England, S1O 2SJ
United Kingdom
Recruiting Contact Person 44-114-226-5213
Cancer Care Ontario - Windsor Regional Cancer Centre *Recruiting*
Windsor, Ontario, N8W 2X3
Canada
Recruiting Caroline Hamm 519-253-5253 ext. 58504
Cookridge Hospital at Leeds Teaching Hospital NHS Trust *Recruiting*
Leeds, England, LS16 6QB
United Kingdom
Recruiting D. Dodwell 44-113-392-6788
Universitats Klinikum Freiburg *Recruiting*
Freiburg, , D-79106
Germany
Recruiting Gerald Gitsch 49-761-270-3024
Sonderborg Sygehus *Recruiting*
Sonderborg, , 6400
Denmark
Recruiting Ebbe Madsen 45-7418-2500
Karolinska Hospital *Recruiting*
Stockholm, , S-171 76
Sweden
Recruiting Jonas Bergh 46-8-517-76279
Hospital Distrital De Faro *Recruiting*
Faro, , 8000
Portugal
Recruiting Irene Furtado 351-389-891-100
Hospital Roosevelt *Recruiting*
Guatemala City, , 01010
Guatemala
Recruiting Luis Zetina Toachie 502-331-5342
Margaret and Charles Juravinski Cancer Centre *Recruiting*
Hamilton, Ontario, L8V 5C2
Canada
Recruiting Richard Tozer 905-387-9495 ext. 64604
Evangelismos Hospital *Recruiting*
Athens, , 10676
Greece
Recruiting Contact Person 30-210-7201-824
Mount Hospital *Recruiting*
Perth, Western Australia, 6000
Australia
Recruiting Guy Van Hazel 08-9481-3072
Reseau Hospitalier De Medecine Sociale *Recruiting*
Baudour, , 7331
Belgium
Recruiting Vincent Richard 32-6576-8111
British Columbia Cancer Agency *Recruiting*
Vancouver, British Columbia, V5Z 4E6
Canada
Recruiting Caroline Lohrisch 604-877-6000
Fraser Valley Cancer Centre at British Columbia Cancer Agency *Recruiting*
Surrey, British Columbia, V3V 1Z2
Canada
Recruiting Brian Norris 604-930-4064
Hospital Santa Rita Irmandade Santa Casa De Porto Alegre *Recruiting*
Porto Alegre, , 91330-490
Brazil
Recruiting Jeferson Vinholes 55-51-3214-8143
Prince Edward Island Cancer Center at Queen Elizabeth Hospital *Recruiting*
Charlottetown, Prince Edward Island, C1A 8T5
Canada
Recruiting Dagny Dryer 902-894-2027
Cazk Groeninghe - Campus St-Niklaas *Recruiting*
Kortrijk, , B-8500
Belgium
Recruiting Contact Person 32-5623-4211
Algoma Reginal Cancer Program at Sault Area Hospital *Recruiting*
Sault Sainte Marie, Ontario, P6B 1Y5
Canada
Recruiting Paul D. Walde 705-759-1234
Wilhelminenspital der Stadt Wien *Recruiting*
Vienna, , A-1160
Austria
Recruiting Heinrich Salzer 43-149-150-4708
Medical Oncology Centre of Rosebank *Recruiting*
Johannesburg, , 2193
South Africa
Recruiting Contact Person 27-11-880-4169
Istituto Clinico Humanitas *Recruiting*
Rozzano (MI), , 20089
Italy
Recruiting Armando Santoro 39-028-224-4584
Trillium Health Centre *Recruiting*
Mississauga, Ontario, L5B 1B8
Canada
Recruiting John Gapski 905-270-3842
Centre Regional Francois Baclesse *Recruiting*
Caen, , 14076
France
Recruiting Contact Person 33-231-45-5050
Hospitais da Universidade de Coimbra (HUC) *Recruiting*
Coimbra, , 3000
Portugal
Recruiting Contact Person 351-239-703-067
Royal Victoria Hospital, Barrie *Recruiting*
Barrie, Ontario, L4M 6M2
Canada
Recruiting Bryn Pressnail 705-728-9802
James Cook University Hospital *Recruiting*
Middlesbrough, England, TS4 3BW
United Kingdom
Recruiting John Hardman 44-1642-85-4616
A. OE. KH Der Statuarstadt Wiener Neustadt *Recruiting*
Wiener Neustadt, , 2700
Austria
Recruiting Werner Kwasny 43-2622-235-210
Ospedale San Filippo Neri *Recruiting*
Rome, , 00135
Italy
Recruiting Giampietro Gasparini 39-06-3306-2237
Clinique Sainte Elisabeth *Recruiting*
Namur, , 5000
Belgium
Recruiting Contact Person 32-8172-0411
Primario U.O. di Oncologia Medica *Recruiting*
Trento, , 38100
Italy
Recruiting Enzo Galligioni 0039-0461-903451/904416
Tokai University School Of Medicine *Recruiting*
Kanagawa, , 259-1193
Japan
Recruiting Yutaka Tokuda 81-463-93-1121
Airedale General Hospital *Recruiting*
West Yorkshire, England, BD20 6TD
United Kingdom
Recruiting S. Crawford 01535-652511
Hotel Dieu Health Sciences Hospital - Niagara *Recruiting*
St. Catharines, Ontario, L2R 5K3
Canada
Recruiting Brian Findlay 905-682-6451
LKH Villach *Recruiting*
Villach, , 9500
Austria
Recruiting Joerg Keckstein 43-4242-2080
Algemeen Ziekenhuis Middelheim *Recruiting*
Antwerp, , 2020
Belgium
Recruiting Contact Person 32-3280-3111
British Columbia Cancer Agency - Vancouver Island Cancer Centre *Recruiting*
Victoria, British Columbia, V8R 6V5
Canada
Recruiting Vanessa Bernstein 250-519-5570
Princess Royal Hospital *Recruiting*
Hull, England, HU8 9HE
United Kingdom
Recruiting M.J. Lind 44-482-676-736
University Hospital of Malmoe *Recruiting*
Malmoe, , 20502
Sweden
Recruiting Gunnar Westman 46-40-331-000
Hopital du Saint-Sacrement, Quebec *Recruiting*
Quebec City, Quebec, G1S 4L8
Canada
Recruiting Jean Robert 418-682-7511
Tom Baker Cancer Center - Calgary *Recruiting*
Calgary, Alberta, T2N 4N2
Canada
Recruiting Barbara Walley 403-670-1013
British Columbia Cancer Agency - Centre for the Southern Interior *Recruiting*
Kelowna, British Columbia, V1Y 5L3
Canada
Recruiting Susan Ellard 250-712-3996
Krankenhaus des Landes Kaernten *Recruiting*
Klagenfurt, , 9026
Austria
Recruiting Ernst Forsthuber 43-463-538-0
Uppsala University Hospital *Recruiting*
Uppsala, , SE-75185
Sweden
Recruiting Carl Blomquist 46-18-611-0000
Landeskrankenhaus St. Poelten *Recruiting*
St. Poelten, , 3100
Austria
Recruiting Peter Balcke 43-2742-300-2971
C.H.C - Asbl *Recruiting*
LIEGE, , B 4000
Belgium
Recruiting Christian Focan 32-4-224-8990
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology *Recruiting*
Warsaw, , 02-781
Poland
Recruiting Contact Person 48-22-644-0024
AKH - Vienna *Recruiting*
Vienna, , 1090
Austria
Recruiting Ernst Kubista 43-1-40400-2881
Instituto Portugues de Oncologia, Centro Regional de Coimbra *Recruiting*
Coimbra, , 3000-075
Portugal
Recruiting Contact Person 351-239-400-200
Toronto East General Hospital *Recruiting*
Toronto, Ontario, M4C 3E7
Canada
Recruiting Yasmin Rahim 416-469-3325
Rebecca Sief Oncology *Recruiting*
Safed, , 13110
Israel
Recruiting Jamal Zidan 972-682-8951
Ospedale Maggiore Ca'Granda *Recruiting*
Milano (Milan), , 20162
Italy
Recruiting Salvatore Siena 39-02-6444-2291
Centre Hospitalier Peltzer-La Tourelle *Recruiting*
Verviers, , B-4800
Belgium
Recruiting Jean Salmon 32-87-212-111
Diana Princess of Wales Hospital *Recruiting*
Grimsby, England, DN33 2BA
United Kingdom
Recruiting Paul Mack 44-1472-874-111
Instituto Portugues de Oncologia de Francisco Gentil - Centro de Lisboa *Recruiting*
Lisbon, , 1099-023 Codex
Portugal
Recruiting Contact Person 351-21-722-9892
Medical University *Recruiting*
Poznan, , 61-878
Poland
Recruiting Contact Person 48-61-854-9019
CancerCare Manitoba *Recruiting*
Winnipeg, Manitoba, R2H 2A6
Canada
Recruiting Debjani Grenier 204-237-2006
Tokyo Metropolitan - Komagome Hospital *Recruiting*
Tokyo, , 113-8677
Japan
Recruiting Masakazu Toi 81-3-3823-2101
Southend NHS Trust Hospital *Recruiting*
Westcliff-On-Sea, England, SS0 0RY
United Kingdom
Recruiting Contact Person 44-1702-22-1039
Clinical Hospital Center Split *Recruiting*
Split, , 21000
Croatia
Recruiting Eduard Vrdoljak 385-21-556-129
Additional Information:
Study ID Numbers: CDR0000256320; EORTC-10011,BIG-01-01,EU-20216,CAN-NCIC-MA24,ROCHE-B016348B,IBCSG-28-02,ROCHE-B016348C
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00045032
Other Stage 1 Breast Cancer Studies:
1. Tamoxifen Compared With LY353381 in Treating Women With Newly Diagnosed Breast Cancer
2. HER-2 Protein Vaccine in Treating Women With Breast Cancer
3. Doxorubicin and Cyclophosphamide Plus Paclitxael With or Without Trastuzumab in Treating Women With Node-Positive Breast Cancer That Overexpresses HER2
4. Prolonged Tamoxifen Compared With Shorter Tamoxifen in Treating Patients Who Have Breast Cancer
5. Surgery to Remove Sentinel Lymph Nodes With or Without Removing Lymph Nodes in the Armpit in Treating Women With Breast Cancer
Related Studies:
Other stage 1 breast cancer Clinical Trials
Other Clinical Trials
Other Kortrijk Clinical Trials
Trastuzumab in Treating Women With Breast Cancer
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