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Search / Trial NCT00045032

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.

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

0 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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