Herceptin (Trastuzumab) in Treating Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Primary Breast Cancer
Launched by HOFFMANN-LA ROCHE · Jan 26, 2003
Trial Information
Current as of July 24, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- • Non-metastatic primary invasive breast cancer overexpressing HER2 (determined by immunohistochemistry 3+ or positive fluorescence in situ hybridization test) that has been histologically confirmed, adequately excised, axillary node positive or negative, and tumor size at least T1c according to Tumor/Node/Metastasis (TNM) staging
- • Completion of at least 4 cycles of (neo-)adjuvant systemic chemotherapy, definitive surgery, and radiotherapy, if applicable
- • Known hormone receptor status
- • Baseline left ventricular ejection fraction (LVEF) greater than or equal to (≥) 55 percent (%)
- Exclusion Criteria:
- • Prior invasive breast carcinoma
- • Other malignancies except for curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix
- • Clinical T4 tumors
- • Cumulative doxorubicin exposure greater than (\>) 360 milligrams per meter-squared (mg/m\^2) or epirubicin \>720 mg/m\^2 or any prior anthracyclines unrelated to the present breast cancer
- • Peripheral stem cell or bone marrow stem cell support
- • Prior mediastinal irradiation except for internal mammary node irradiation for the present breast cancer
- • Non-irradiated internal mammary nodes or supraclavicular lymph node involvement
- • Prior anti-HER2 therapy for any other reason or other prior biologic or immunotherapy for breast cancer
- • Concurrent anti-cancer treatment in another investigational trial
- • Serious cardiac or pulmonary conditions/illness, or any other conditions that could interfere with planned treatment
- • Poor hematologic, hepatic, or renal function
- • Pregnancy or lactation
- • Women of childbearing potential or less than 1 year post-menopause unwilling to use adequate contraceptive measures
About Hoffmann La Roche
Hoffmann-La Roche, commonly known as Roche, is a global leader in biotechnology and pharmaceuticals, committed to advancing healthcare through innovative research and development. With a strong focus on oncology, immunology, infectious diseases, and central nervous system disorders, Roche leverages cutting-edge science to deliver transformative therapies and diagnostics. The company is dedicated to improving patient outcomes by conducting rigorous clinical trials and collaborating with healthcare professionals and organizations worldwide. Roche's unwavering commitment to precision medicine and personalized healthcare positions it at the forefront of the industry, driving progress in the quest for effective treatments and improved patient care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Leuven, , Belgium
Pavia, , Italy
Maastricht, , Netherlands
Gdansk, , Poland
Linkoping, , Sweden
Brussels, , Belgium
Huddersfield, West Yorks, England, United Kingdom
Brussels, , Belgium
La Louviere, , Belgium
Caen, , France
Aviano, , Italy
Warsaw, , Poland
Carpi, , Italy
Brussels, , Belgium
Namur, , Belgium
Limoges, , France
Lausanne, , Switzerland
Toronto, Ontario, Canada
Cuneo, , Italy
Parma, , Italy
Perugia, , Italy
Toronto, Ontario, Canada
Utrecht, , Netherlands
Victoria, British Columbia, Canada
St. Gallen, , Switzerland
Calgary, Alberta, Canada
Saskatoon, Saskatchewan, Canada
Salzburg, , Austria
Kelowna, British Columbia, Canada
St. Catharines, Ontario, Canada
Toronto, Ontario, Canada
Quebec City, Quebec, Canada
Verviers, , Belgium
Innsbruck, , Austria
Turin, , Italy
Aarau, , Switzerland
Regina, Saskatchewan, Canada
Charleroi, , Belgium
Heidelberg, , Germany
Sittard, , Netherlands
Surrey, British Columbia, Canada
Vancouver, British Columbia, Canada
Hamilton, Ontario, Canada
Bogota, , Colombia
Rome, , Italy
Johannesburg, , South Africa
Berlin, , Germany
Brescia, , Italy
Milan, , Italy
Freiburg, , Germany
Munich, , Germany
Budapest, , Hungary
Bradford, England, United Kingdom
Genoa, , Italy
Barcelona, , Spain
Sevilla, , Spain
Munich, , Germany
Shatin, New Territories, , Hong Kong
Como, , Italy
Mantova, , Italy
Reggio Emilia, , Italy
Johannesburg, , South Africa
Klagenfurt, , Austria
Bergamo, , Italy
Las Palmas, , Spain
Wiesbaden, , Germany
Madrid, , Spain
West Yorkshire, England, United Kingdom
Lisbon, , Portugal
Stockholm, , Sweden
Umea, , Sweden
Middlesbrough, England, United Kingdom
Barrie, Ontario, Canada
Windsor, Ontario, Canada
Magdeburg, , Germany
Sheffield, England, United Kingdom
Metz, , France
Antwerp, , Belgium
Liege, , Belgium
Cork, , Ireland
Bern, , Switzerland
Uppsala, , Sweden
Split, , Croatia
Mississauga, Ontario, Canada
Sault Sainte Marie, Ontario, Canada
Charlottetown, , Canada
Essen, , Germany
Alba, , Italy
Guadalajara, , Spain
La Laguna, , Spain
Sabadell, , Spain
Grimsby, England, United Kingdom
Basel, , Switzerland
Bologna, , Italy
Milan, , Italy
Zurich, , Switzerland
Newcastle Upon Tyne, England, United Kingdom
Westcliff On Sea, England, United Kingdom
Liege, , Belgium
Athens, , Greece
Turin, , Italy
Vigo Pontevedra, , Spain
Hull, England, United Kingdom
Perth, Western Australia, Australia
Kortrijk, , Belgium
Leeds, England, United Kingdom
Porto Alegre, Rio Grande Do Sul, Brazil
Budapest, , Hungary
Molndal, , Sweden
Rome, , Italy
Kiel, , Germany
Ulm, , Germany
Halle, , Germany
Santiago, , Chile
Santiago, , Chile
Biella, , Italy
Karlsruhe, , Germany
Hong Kong, , China
Moscow, , Russian Federation
Mendrisio, , Switzerland
Bangkok, , Thailand
Modena, , Italy
Bangkok, , Thailand
Budapest, , Hungary
Seoul, , Korea, Republic Of
Budapest, , Hungary
Uppsala, , Sweden
Winnipeg, Manitoba, Canada
Cape Town, , South Africa
Buenos Aires, , Argentina
Geelong, Australian Capital Territory, Australia
Toowoomba, Queensland, Australia
Geelong, Victoria, Australia
Feldkirch Tisis, , Austria
Linz Donau, , Austria
St. Poelten, , Austria
Vienna, , Austria
Vienna, , Austria
Villach, , Austria
Voecklabruck, , Austria
Wiener Neustadt, , Austria
Baudour, , Belgium
Oostende, , Belgium
Porto Alegre, , Brazil
Porto Alegre, , Brazil
Rio De Janeiro, , Brazil
Santo Andre, , Brazil
Santiago, , Chile
Santiago, , Chile
Santiago, , Chile
Hong Kong, , China
Wuhan, , China
Esbjerg, , Denmark
Herning, , Denmark
Hillerod, , Denmark
Naestved, , Denmark
Sonderborg, , Denmark
Hanover, , Germany
Leonberg, , Germany
Rostock, , Germany
Heraklion, Crete, Greece
Guatemala City, , Guatemala
Guatemala City, , Guatemala
Safed, , Israel
Alzano Lombardo, , Italy
Cagliari, , Italy
Firenze (Florence), , Italy
Florence, , Italy
Forli, , Italy
Lecco, , Italy
Livorno, , Italy
Rozzano, , Italy
Sassari, , Italy
Trento, , Italy
Kanagawa, , Japan
Tokyo, , Japan
Seoul, , Korea, Republic Of
Gliwice, , Poland
Poznan, , Poland
Coimbra, , Portugal
Coimbra, , Portugal
Coimbra, , Portugal
Faro, , Portugal
Lisboa, , Portugal
Moscow, , Russian Federation
Singapore, , Singapore
Durban, , South Africa
Lynnwood, , South Africa
Alzira, , Spain
Granada, , Spain
Huelva, , Spain
Jaen, , Spain
La Coruna, , Spain
Las Palmas De Gran Canaria, , Spain
Orense, , Spain
Pontevedra, , Spain
Santa Cruz De Tenerife, , Spain
Toledo, , Spain
Valencia, , Spain
Zaragoza, , Spain
Malmo, , Sweden
Chur, , Switzerland
Chelmsford, Essex, England, United Kingdom
Epping Essex, England, United Kingdom
London, England, United Kingdom
Charlottetown, Prince Edward Island, Canada
Patients applied
Trial Officials
Martine J. Piccart-Gebhart, MD, PhD
Study Chair
Jules Bordet Institute
Robert E. Coleman, MD, FRCP
Study Chair
Cancer Research Centre at Weston Park Hospital
Karen A. Gelmon, MD
Study Chair
British Columbia Cancer Agency
Kathleen I. Pritchard, MD
Study Chair
Toronto Sunnybrook Regional Cancer Centre
Olivia Pagani, MD
Study Chair
Ospedale Beata Vergine
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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