Spots Global Cancer Trial Database for Exemestane Compared With Tamoxifen in Treating Women With Locally Recurrent or Metastatic Breast Cancer
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Trial Identification
Brief Title: Exemestane Compared With Tamoxifen in Treating Women With Locally Recurrent or Metastatic Breast Cancer
Official Title: RANDOMIZED PHASE II STUDY IN FIRST LINE HORMONAL TREATMENT FOR METASTATIC BREAST CANCER WITH EXEMESTANE OR TAMOXIFEN IN POSTMENOPAUSAL PATIENTS
Study ID: NCT00002777
Conditions
Study Description
Brief Summary: RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using exemestane or tamoxifen may fight cancer by blocking the uptake of estrogen. PURPOSE: Randomized phase II/III trial to compare the effectiveness of exemestane with that of tamoxifen in treating postmenopausal women who have locally recurrent or metastatic breast cancer.
Detailed Description: OBJECTIVES: * Compare the efficacy of exemestane vs tamoxifen, in terms of progression-free survival, in postmenopausal women with locally recurrent or metastatic breast cancer. * Determine the safety profile of exemestane in these patients. * Compare the overall survival of these patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. (Phase II of this study closed as of 6/14/00). Patients are stratified by participating center, prior adjuvant tamoxifen (yes vs no), prior chemotherapy for metastatic disease (yes vs no), and dominant site of metastasis (visceral with or without others vs bone only vs bone and soft tissue vs soft tissue only). Patients are randomized to receive either oral exemestane or oral tamoxifen daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 18 months and then at least every 6 months thereafter. PROJECTED ACCRUAL: A total of 342 patients will be accrued for this study within 4.7 years.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Liverpool Hospital, Liverpool, New South Wales, Australia
Princess Alexandra Hospital, Brisbane, Queensland, Australia
Austin Hospital, Heidelberg, Victoria, Australia
Bankstown - Lidcombe Hospital, Bankstown, , Australia
Algemeen Ziekenhuis Middelheim, Antwerp, , Belgium
Institut Jules Bordet, Brussels (Bruxelles), , Belgium
Centre Hospitalier Etterbeek Ixelles, Brussels (Bruxelles), , Belgium
Hopital de Jolimont, Haine Saint Paul, , Belgium
Centre Hospitalier Universitaire de Tivoli, La Louviere, , Belgium
U.Z. Gasthuisberg, Leuven, , Belgium
Clinique Sainte Elisabeth, Namur, , Belgium
Algemeen Ziekenhuis Sint-Augustinus, Wilrijk, , Belgium
Institut Bergonie, Bordeaux, , France
Centre Regional Francois Baclesse, Caen, , France
Centre Jean Perrin, Clermont-Ferrand, , France
Centre de Lutte Contre le Cancer, Georges-Francois Leclerc, Dijon, , France
Centre Leon Berard, Lyon, , France
Centre Eugene Marquis, Rennes, , France
Centre Henri Becquerel, Rouen, , France
Centre Rene Huguenin, Saint Cloud, , France
University of Malaysia Medical Center, Kuala Lumpur, , Malaysia
Leyenburg Ziekenhuis, 's-Gravenhage (Den Haag, The Hague), , Netherlands
Ziekenhuis Eemland de Lichtenberg, Amersfont, , Netherlands
Antoni van Leeuwenhoekhuis, Amsterdam, , Netherlands
Onze Lieve Vrouwe Gasthuis, Amsterdam, , Netherlands
Catharina Ziekenhuis, Eindhoven, , Netherlands
Leiden University Medical Center, Leiden, , Netherlands
Medisch Centrum Haaglanden Locatle Antoniushove, Leidschendam, , Netherlands
Academisch Ziekenhuis Maastricht, Maastricht, , Netherlands
University Medical Center Nijmegen, Nijmegen, , Netherlands
Waterlandziekenhuis, Purmerend, , Netherlands
Saint Laurentius Ziekenhuis, Roermond, , Netherlands
Rotterdam Cancer Institute, Rotterdam, , Netherlands
Maasland Hospital, Sittard, , Netherlands
St. Elisabeth Ziekenhuis, Tilburg, , Netherlands
Diakonessenhuis Utrecht, Utrecht, , Netherlands
Sint Joseph Ziekenhuis, Veldhoven, , Netherlands
Chong Hua Medical Arts Center, Cebu City, , Philippines
Medical University of Gdansk, Gdansk, , Poland
Russian Academy of Medical Sciences Cancer Research Center, Moscow, , Russian Federation
Petrov Research Institute of Oncology, Saint Petersburg, , Russian Federation
Institute of Oncology, Ljubljana, Ljubljana, , Slovenia
Tri-Service General Hospital, Taipei, , Taiwan
Siriraj Hospital, Bangkok, , Thailand
Guy's and St. Thomas' Hospitals Trust, London, England, United Kingdom
South Tees Hospitals NHS Trust, Middlesbrough, Cleveland, England, United Kingdom
Weston Park Hospital, Sheffield, England, United Kingdom
Western General Hospital, Edinburgh, Scotland, United Kingdom
Contact Details
Name: Robert Paridaens, MD, PhD
Affiliation: University Hospital, Gasthuisberg
Role: STUDY_CHAIR
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