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| Sponsor: | Hoffmann-La Roche |
|---|---|
| Information provided by: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00022672 |
Purpose
This 2 arm study will assess the safety and efficacy of adding intravenous Herceptin to daily oral anastrozole (Arimidex) tablets as first- and second-line treatment in postmenopausal patients with HER2 overexpressing metastatic breast cancer (ER+ve and/or PR+ve). Patients will be randomized to receive either anastrazole 1mg po daily,or anastrazole 1mg po daily + a loading dose of Herceptin 4mg/kg iv followed by weekly doses of Herceptin 2mg/kg iv. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: trastuzumab [Herceptin] Drug: Anastrazole |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Open-label Study of the Effect of Herceptin Plus Arimidex Compared With Arimidex Alone on Progression-free Survival in Patients With HER2-positive and Hormone-receptor Positive Metastatic Breast Cancer |
| Estimated Enrollment: | 202 |
| Study Start Date: | January 2001 |
| Estimated Study Completion Date: | July 2006 |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: trastuzumab [Herceptin]
4mg/kg iv loading dose, followed by 2mg/kg iv weekly
Drug: Anastrazole
1mg po daily
|
| 2: Active Comparator |
Drug: Anastrazole
1mg po daily
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| PHOENIX, Arizona, United States, 85006 | |
| United States, Arkansas | |
| LITTLE ROCK, Arkansas, United States, 72205-7199 | |
| United States, California | |
| LOS ANGELES, California, United States, 90048 | |
| VALLEJO, California, United States, 94589 | |
| United States, Florida | |
| PLANTATION, Florida, United States, 33324 | |
| GAINESVILLE, Florida, United States, 32605 | |
| MIAMI, Florida, United States, 33176 | |
| United States, Illinois | |
| CHICAGO, Illinois, United States, 60637 | |
| CHICAGO, Illinois, United States, 60612 | |
| United States, Kansas | |
| KANSAS CITY, Kansas, United States, 66160 | |
| United States, Maine | |
| SCARBOROUGH, Maine, United States, 04074 | |
| United States, Michigan | |
| DETROIT, Michigan, United States, 48202-2689 | |
| United States, New Jersey | |
| HACKENSACK, New Jersey, United States, 07601 | |
| United States, New Mexico | |
| ALBUQUERQUE, New Mexico, United States, 87131-5636 | |
| SANTA FE, New Mexico, United States, 87505 | |
| United States, New York | |
| ROCHESTER, New York, United States, 14642 | |
| United States, North Carolina | |
| CHAPEL HILL, North Carolina, United States, 27599 | |
| United States, Ohio | |
| CINCINNATI, Ohio, United States, 45267-0562 | |
| CLEVELAND, Ohio, United States, 44106 | |
| United States, Pennsylvania | |
| HERSHEY, Pennsylvania, United States, 17033-0850 | |
| Australia | |
| MELBOURNE, Australia, 3128 | |
| DARLINGHURST, Australia, 2010 | |
| WARATAH, Australia, 2298 | |
| Brazil | |
| PORTO ALEGRE, Brazil, 90610-000 | |
| Bulgaria | |
| SOFIA, Bulgaria, 1527 | |
| STARA ZAGORA, Bulgaria, 8000 | |
| PLOVDIV, Bulgaria, 4000 | |
| Canada, Alberta | |
| CALGARY, Alberta, Canada, T2N 4N2 | |
| EDMONTON, Alberta, Canada, T6G 1Z2 | |
| Canada, British Columbia | |
| VICTORIA, British Columbia, Canada, V8R 6V5 | |
| Canada, Manitoba | |
| WINNIPEG, Manitoba, Canada, R3E 0V9 | |
| Canada, Ontario | |
| TORONTO, Ontario, Canada, M5G 2M9 | |
| TORONTO, Ontario, Canada, M4N 3M5 | |
| OSHAWA, Ontario, Canada, L1G 2B9 | |
| Canada, Quebec | |
| QUEBEC CITY, Quebec, Canada, G1S 4L8 | |
| MONTREAL, Quebec, Canada, H1T 2M4 | |
| China | |
| BEIJING, China, 100021 | |
| SHANGHAI, China, 200025 | |
| WUHAN, China, 430030 | |
| SHANGHAI, China, 200032 | |
| BEIJING, China, 100071 | |
| France | |
| NICE, France, 06189 | |
| AVIGNON, France, 84082 | |
| Germany | |
| MÜNCHEN, Germany, 80673 | |
| FRANKFURT AM MAIN, Germany, 60596 | |
| KIEL, Germany, 24105 | |
| TRIER, Germany, 54290 | |
| Hong Kong | |
| HONG KONG, Hong Kong, 852 | |
| Hungary | |
| BUDAPEST, Hungary, 1122 | |
| India | |
| CUTTACK, India, 753 007 | |
| NEW DELHI, India, 110 029 | |
| LUDHIANA, India, 141 001 | |
| AHMEDABAD, India, 380 016 | |
| NEW DELHI, India, 110 085 | |
| MUMBAI, India, 400 012 | |
| BANGALORE, India, 560 029 | |
| CHENNAI, India, 600 020 | |
| NEW DELHI, India, 110 060 | |
| Israel | |
| REHOVOT, Israel, 76100 | |
| PETACH TIKVA, Israel, 49100 | |
| TEL AVIV, Israel, 64239 | |
| RAMAT GAN, Israel, 52621 | |
| HAIFA, Israel | |
| HAIFA, Israel, 31096 | |
| Italy | |
| GENOVA, Italy, 16132 | |
| Lithuania | |
| VILNIUS, Lithuania, 2600 | |
| Mexico | |
| MEXICO CITY, Mexico, 14000 | |
| GUADALAJARA, Mexico, 44340 | |
| Netherlands | |
| ROTTERDAM, Netherlands, 3075 EA | |
| AMSTERDAM, Netherlands, 1081 HV | |
| Norway | |
| TRONDHEIM, Norway, 7006 | |
| Poland | |
| SZCZECIN, Poland, 71-730 | |
| WARSZAWA, Poland, 02-781 | |
| LODZ, Poland, 94-306 | |
| BYDGOSZCZ, Poland, 85-796 | |
| GLIWICE, Poland, 44-101 | |
| BIALYSTOK, Poland, 15-027 | |
| KRAKOW, Poland, 31-115 | |
| WARSZAWA, Poland, 00-909 | |
| Russian Federation | |
| MOSCOW, Russian Federation, 115478 | |
| MOSCOW, Russian Federation, 125284 | |
| MOSCOW, Russian Federation, 107005 | |
| MOSCOW, Russian Federation, 121356 | |
| ST PETERSBURG, Russian Federation, 197758 | |
| KAZAN, Russian Federation, 420029 | |
| BARNAUL, Russian Federation, 656049 | |
| IZHEVSK, Russian Federation, 426009 | |
| ST PETERSBURG, Russian Federation, 197022 | |
| KRASNODAR, Russian Federation, 350080 | |
| ST PETERSBURG, Russian Federation, 189646 | |
| MOSCOW, Russian Federation, 117837 | |
| UFA, Russian Federation, 450054 | |
| South Africa | |
| PRETORIA, South Africa | |
| FLORACLIFFE, South Africa, 1715 | |
| Spain | |
| MADRID, Spain, 28007 | |
| MADRID, Spain, 28041 | |
| VALENCIA, Spain, 46009 | |
| CÓRDOBA, Spain, 14004 | |
| MADRID, Spain, 28034 | |
| REUS, Spain, 43201 | |
| BARCELONA, Spain, 08036 | |
| MATARO, Spain, 08304 | |
| GIRONA, Spain, 17007 | |
| Sweden | |
| BORAS, Sweden, 50182 | |
| STOCKHOLM, Sweden, 17176 | |
| OEREBRO, Sweden, 70185 | |
| GAEVLE, Sweden, 80187 | |
| Taiwan | |
| TAIPEI, Taiwan, 112 | |
| TAIPEI, Taiwan, 105 | |
| Turkey | |
| ANKARA, Turkey, 06500 | |
| ANKARA, Turkey, 06100 | |
| ISTANBUL, Turkey, 34300 | |
| ISTANBUL, Turkey, 34390 | |
| IZMIR, Turkey, 35100 | |
| Ukraine | |
| SUMY, Ukraine, 40005 | |
| ODESSA, Ukraine, 65055 | |
| LVOV, Ukraine, 79031 | |
| KIEV, Ukraine, 03022 | |
| KIEV, Ukraine | |
| ZAPOROZHYE, Ukraine, 69104 | |
| United Kingdom | |
| GUILDFORD, United Kingdom, GU2 5XX | |
| SWANSEA, United Kingdom, SA2 8QA | |
| CARDIFF, United Kingdom, CF14 2TL | |
| EDINBURGH, United Kingdom, EH4 2XU | |
| MANCHESTER, United Kingdom, M20 4BX | |
| LONDON, United Kingdom, SE1 9RT | |
| NEWCASTLE UPON TYNE, United Kingdom, NE4 6BE | |
| MERSEYSIDE, United Kingdom, CH63 45Y | |
| IPSWICH, United Kingdom, IP4 5PD | |
| SOUTHAMPTON, United Kingdom, SO16 6YD | |
| LONDON, United Kingdom, NW3 2QG | |
| Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
More Information
| Responsible Party: | Hoffmann-La Roche ( Clinical Trials, Study Director ) |
| Study ID Numbers: | BO16216 |
| Study First Received: | August 10, 2001 |
| Last Updated: | September 16, 2009 |
| ClinicalTrials.gov Identifier: | NCT00022672 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Anastrozole Molecular Mechanisms of Pharmacological Action Skin Diseases Antineoplastic Agents, Hormonal Antineoplastic Agents Breast Neoplasms Enzyme Inhibitors |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Trastuzumab Aromatase Inhibitors Breast Diseases |
