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| Sponsor: | European Organization for Research and Treatment of Cancer |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002777 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: exemestane Drug: tamoxifen citrate |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | RANDOMIZED PHASE II STUDY IN FIRST LINE HORMONAL TREATMENT FOR METASTATIC BREAST CANCER WITH EXEMESTANE OR TAMOXIFEN IN POSTMENOPAUSAL PATIENTS |
| Estimated Enrollment: | 342 |
| Study Start Date: | May 1996 |
OBJECTIVES:
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
At least one bidimensionally measurable or evaluable lesion
The following are not considered evaluable:
Hormone receptor status:
Estrogen receptor positive or progesterone receptor positive, defined by 1 of the following:
Unknown receptor status eligible provided:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Postmenopausal by 1 of the following:
Chemotherapy induced menopause if:
Surgical castration
Performance status:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Hide Study Locations| Australia | |
| Bankstown - Lidcombe Hospital | |
| Bankstown, Australia, NSW 2200 | |
| Australia, New South Wales | |
| Liverpool Hospital | |
| Liverpool, New South Wales, Australia, 2170 | |
| Australia, Queensland | |
| Princess Alexandra Hospital | |
| Brisbane, Queensland, Australia, 4102 | |
| Australia, Victoria | |
| Austin Hospital | |
| Heidelberg, Victoria, Australia, 3084 | |
| Belgium | |
| Algemeen Ziekenhuis Middelheim | |
| Antwerp, Belgium, 2020 | |
| Algemeen Ziekenhuis Sint-Augustinus | |
| Wilrijk, Belgium, 2610 | |
| U.Z. Gasthuisberg | |
| Leuven, Belgium, B-3000 | |
| Centre Hospitalier Universitaire de Tivoli | |
| La Louviere, Belgium, 7100 | |
| Clinique Sainte Elisabeth | |
| Namur, Belgium, 5000 | |
| Hopital de Jolimont | |
| Haine Saint Paul, Belgium, 7100 | |
| Institut Jules Bordet | |
| Brussels (Bruxelles), Belgium, 1000 | |
| Centre Hospitalier Etterbeek Ixelles | |
| Brussels (Bruxelles), Belgium, B-1050 | |
| France | |
| Centre de Lutte Contre le Cancer, Georges-Francois Leclerc | |
| Dijon, France, 21079 | |
| Centre Eugene Marquis | |
| Rennes, France, 35064 | |
| Centre Henri Becquerel | |
| Rouen, France, 76038 | |
| Centre Jean Perrin | |
| Clermont-Ferrand, France, 63011 | |
| Centre Leon Berard | |
| Lyon, France, 69373 | |
| Centre Regional Francois Baclesse | |
| Caen, France, 14076 | |
| Centre Rene Huguenin | |
| Saint Cloud, France, 92211 | |
| Institut Bergonie | |
| Bordeaux, France, 33076 | |
| Malaysia | |
| University of Malaysia Medical Center | |
| Kuala Lumpur, Malaysia, 59100 | |
| Netherlands | |
| Academisch Ziekenhuis Maastricht | |
| Maastricht, Netherlands, 6202 AZ | |
| Antoni van Leeuwenhoekhuis | |
| Amsterdam, Netherlands, 1066 CX | |
| Catharina Ziekenhuis | |
| Eindhoven, Netherlands, 5602 ZA | |
| Diakonessenhuis Utrecht | |
| Utrecht, Netherlands, 3508 TG | |
| Leiden University Medical Center | |
| Leiden, Netherlands, 2300 CA | |
| Leyenburg Ziekenhuis | |
| 's-Gravenhage (Den Haag, The Hague), Netherlands, 2545 CH | |
| Maasland Hospital | |
| Sittard, Netherlands, 6131 BK | |
| Medisch Centrum Haaglanden Locatle Antoniushove | |
| Leidschendam, Netherlands, 2262 BA | |
| Onze Lieve Vrouwe Gasthuis | |
| Amsterdam, Netherlands, 1091 HA | |
| Waterlandziekenhuis | |
| Purmerend, Netherlands, 1440 AG | |
| Saint Laurentius Ziekenhuis | |
| Roermond, Netherlands, 6043 CV | |
| Sint Joseph Ziekenhuis | |
| Veldhoven, Netherlands, 5500 MB DB | |
| St. Elisabeth Ziekenhuis | |
| Tilburg, Netherlands, 5022 GC | |
| University Medical Center Nijmegen | |
| Nijmegen, Netherlands, NL-6500 HB | |
| Rotterdam Cancer Institute | |
| Rotterdam, Netherlands, 3075 EA | |
| Ziekenhuis Eemland de Lichtenberg | |
| Amersfont, Netherlands, 3016 CP | |
| Philippines | |
| Chong Hua Medical Arts Center | |
| Cebu City, Philippines, 6000 | |
| Poland | |
| Medical University of Gdansk | |
| Gdansk, Poland, 80-211 | |
| Russian Federation | |
| Petrov Research Institute of Oncology | |
| Saint Petersburg, Russian Federation, 197758 | |
| Russian Academy of Medical Sciences Cancer Research Center | |
| Moscow, Russian Federation, 115478 | |
| Slovenia | |
| Institute of Oncology, Ljubljana | |
| Ljubljana, Slovenia, Sl-1000 | |
| Taiwan | |
| Tri-Service General Hospital | |
| Taipei, Taiwan, NEIHU- 114 | |
| Thailand | |
| Siriraj Hospital | |
| Bangkok, Thailand, 10700 | |
| United Kingdom, England | |
| Guy's and St. Thomas' Hospitals Trust | |
| London, England, United Kingdom, SE1 9RT | |
| South Tees Hospitals NHS Trust | |
| Middlesbrough, Cleveland, England, United Kingdom, TS4 3BW | |
| Weston Park Hospital | |
| Sheffield, England, United Kingdom, S1O 2SJ | |
| United Kingdom, Scotland | |
| Western General Hospital | |
| Edinburgh, Scotland, United Kingdom, EH4 2XU | |
| Study Chair: | Robert Paridaens, MD, PhD | U.Z. Gasthuisberg |
More Information
| Study ID Numbers: | CDR0000064764, EORTC-10951, PHARMACIA-EORTC-10951 |
| Study First Received: | November 1, 1999 |
| Last Updated: | November 25, 2008 |
| ClinicalTrials.gov Identifier: | NCT00002777 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV breast cancer recurrent breast cancer |
|
Estrogen Antagonists Molecular Mechanisms of Pharmacological Action Skin Diseases Antineoplastic Agents, Hormonal Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Breast Neoplasms Enzyme Inhibitors Bone Density Conservation Agents |
Selective Estrogen Receptor Modulators Tamoxifen Pharmacologic Actions Estrogen Receptor Modulators Neoplasms Neoplasms by Site Therapeutic Uses Exemestane Aromatase Inhibitors Breast Diseases |