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Home > "E" Clinical Trials Conditions > Exemestane Compared With Tamoxifen in Treating Women With Locally Recurrent or Metastatic Breast Cancer  Exemestane Compared With Tamoxifen in Treating Women With Locally Recurrent or Metastatic Breast Cancer
Exemestane Compared With Tamoxifen in Treating Women With Locally Recurrent or Metastatic Breast Cancer
For Condition: stage 4 breast cancer,recurrent breast cancer
Status: No longer recruiting
Sponsor(s): EORTC Breast Cancer Cooperative Group ,
Synopsis: 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.
Details: OBJECTIVES: I. Compare the efficacy of exemestane vs tamoxifen, in terms of progression-free survival, in postmenopausal women with locally recurrent or metastatic breast cancer. II. Determine the safety profile of exemestane in these patients. III. Compare the overall survival of these patients treated with these regimens. PROTOCOL 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 768 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Female
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically or cytologically proven adenocarcinoma of the breast that is metastatic and progressive or locally recurrent and inoperable At least one bidimensionally measurable or evaluable lesion - Lytic bone lesions on x-ray/CT scan, surrounded by calcified bone, and at least 1 cm - Bidimensionally measurable extraosseous disease required for patients on bisphosphonates - The following are not considered evaluable: *Previously irradiated lesions *Lymphangitic spread *Ascites *Blastic bone lesions *Pleural effusions No rapidly progressive disease for which hormonal therapy is not indicated No massive visceral disease (i.e., more than one third of any organ) No brain metastases Hormone receptor status: - Estrogen receptor positive or progesterone receptor positive, defined by 1 of the following: *At least 10 femtomoles H3-estrogen or at least 20 femtomoles *H3 progesterone binding per mg of cytosol protein by DCC or sucrose density method *At least 0.10 femtomoles H3-estrogen or at least 0.20 femtomoles *H3-progesterone binding per mg of DNA by IF/EIA technique *Positive immunohistochemistry noted on pathology report - Unknown receptor status eligible provided: Disease-free interval of at least 2 years since adjuvant therapy or initial surgery (if no adjuvant therapy), including most recently treated tumor in bilateral breast cancer if status unknown in one primary tumor --Prior/Concurrent Therapy-- Biologic therapy: No concurrent immunotherapy Chemotherapy: - See Disease Characteristics - At least 3 weeks since chemotherapy for metastatic disease and recovered - No more than 1 prior chemotherapy regimen for metastatic disease - Prior adjuvant chemotherapy allowed if disease free for at least 6 months - No concurrent chemotherapy Endocrine therapy: - No prior hormonal therapy for advanced disease (e.g., tamoxifen or LHRH agonists) - Prior adjuvant tamoxifen allowed if disease free for at least 6 months - No other concurrent hormonal therapy, including steroids Radiotherapy: - Recovered from toxic effects of prior radiotherapy - Concurrent palliative radiotherapy, including whole brain irradiation, allowed Surgery: - See Disease Characteristics - No prior ovariectomy for advanced disease Other: - No other concurrent investigational drugs - Concurrent bisphosphonates allowed if short term (7 days) for hypercalcemia due to suspect tumor flare or if on prior bisphosphonates with bidimensionally measurable extraosseous lesion --Patient Characteristics-- Age: 18 and over Sex: Female Menopausal status: Postmenopausal by 1 of the following: - Natural menopause and more than 1 year since last menstrual period (LMP) - Radiation-induced oophorectomy and more than 1 year since LMP - Chemotherapy induced menopause if: *At least 1 year since LMP (+ 1 year post-tamoxifen) *Serum FSH and LH and plasma estradiol levels in postmenopausal range *LHRH-induced amenorrhea - Surgical castration - Patients under age 56 with prior hysterectomy and 1 or both ovaries intact or tamoxifen-induced amenorrhea with at least 12 months since prior tamoxifen must have postmenopausal serum FSH and LH and plasma estradiol concentrations Performance status: ECOG (WHO) 0-2 Hematopoietic: - Absolute neutrophil count at least 1,500/mm3 - Platelet count at least 100,000/mm3 Hepatic: - Bilirubin less than 1.5 times upper limit of normal (ULN) - SGOT/SGPT less than 2.5 times ULN (less than 5 times ULN with liver metastases) Renal: Creatinine less than 1.5 times ULN Cardiovascular: No deep venous thrombosis Other: - No mental incapacitation - No severe concurrent disease - No prior or concurrent malignancy except curatively treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertParidaens, Study Chair, EORTC Breast Cancer Cooperative Group
Algemeen Ziekenhuis Sint-Augustinus
Wilrijk, , 2610
Belgium
Sint Joseph Ziekenhuis
Veldhoven, , 5500 MB DB
Netherlands
U.Z. Gasthuisberg
Leuven, , B-3000
Belgium
Petrov Research Institute of Oncology
Saint Petersburg, , 197758
Russian Federation
Bankstown - Lidcombe Hospital
Bankstown, , NSW 2200
Australia
Institut Bergonie
Bordeaux, , 33076
France
Ziekenhuis Eemland de Lichtenberg
Amersfont, , 3016 CP
Netherlands
Centre Leon Berard
Lyon, , 69373
France
Princess Alexandra Hospital
Brisbane, Queensland, 4102
Australia
Chong Hua Medical Arts Center
Cebu City, , 6000
Philippines
Centre Eugene Marquis
Rennes, , 35064
France
Saint Laurentius Ziekenhuis
Roermond, , 6043 CV
Netherlands
Antoni van Leeuwenhoekhuis
Amsterdam, , 1066 CX
Netherlands
Siriraj Hospital
Bangkok, , 10700
Thailand
Centre Jean Perrin
Clermont-Ferrand, , 63011
France
Centre Regional Francois Baclesse
Caen, , 14076
France
St. Elisabeth Ziekenhuis
Tilburg, , 5022 GC
Netherlands
Onze Lieve Vrouwe Gasthuis
Amsterdam, , 1091 HA
Netherlands
Centre Hospitalier Universitaire de Tivoli
La Louviere, , 7100
Belgium
Tri-Service General Hospital
Taipei, , NEIHU- 114
Taiwan, Province of China
Medical University of Gdansk
Gdansk, , 80-211
Poland
Waterlandziekenhuis
Purmerend, , 1440 AG
Netherlands
Austin Hospital
Heidelberg, Victoria, 3084
Australia
Russian Academy of Medical Sciences Cancer Research Center
Moscow, , 115478
Russian Federation
Catharina Ziekenhuis
Eindhoven, , 5602 ZA
Netherlands
Clinique Sainte Elisabeth
Namur, , 5000
Belgium
Guy's and St. Thomas' Hospitals Trust
London, England, SE1 9RT
United Kingdom
Western General Hospital
Edinburgh, Scotland, EH4 2XU
United Kingdom
Centre Rene Huguenin
Saint Cloud, , 92211
France
University Medical Center Nijmegen
Nijmegen, , NL-6500 HB
Netherlands
South Tees Hospitals NHS Trust
Middlesbrough, Cleveland, England, TS4 3BW
United Kingdom
Hopital de Jolimont
Haine-Saint-Paul, , 7100
Belgium
Maasland Hospital
Sittard, , 6131 BK
Netherlands
Rotterdam Cancer Institute
Rotterdam, , 3075 EA
Netherlands
University of Malaysia Medical Center
Kuala Lumpur, , 59100
Malaysia
Medisch Centrum Haaglanden Locatle Antoniushove
Leidschendam, , 2262 BA
Netherlands
Leiden University Medical Center
Leiden, , 2300 CA
Netherlands
Leyenburg Ziekenhuis
's-Gravenhage (Den Haag, The Hague), , 2545 CH
Netherlands
Centre Hospitalier Etterbeek Ixelles
Brussels (Bruxelles), , B-1050
Belgium
Centre de Lutte Contre le Cancer, Georges-Francois Leclerc
Dijon, , 21079
France
Diakonessenhuis Utrecht
Utrecht, , 3508 TG
Netherlands
Algemeen Ziekenhuis Middelheim
Antwerp, , 2020
Belgium
Institut Jules Bordet
Brussels (Bruxelles), , 1000
Belgium
Liverpool Hospital
Liverpool, New South Wales, 2170
Australia
Weston Park Hospital
Sheffield, England, S1O 2SJ
United Kingdom
Centre Henri Becquerel
Rouen, , 76038
France
Academisch Ziekenhuis Maastricht
Maastricht, , 6202 AZ
Netherlands
Institute of Oncology, Ljubljana
Ljubljana, , Sl-1000
Slovenia
Additional Information:
Study ID Numbers: CDR0000064764; EORTC-10951,PHARMACIA-EORTC-10951
Study Start Date: June 2001
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002777
Other Stage 4 Breast Cancer Studies:
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2. Monoclonal Antibody Therapy and Docetaxel in Treating Women With Metastatic or Recurrent Breast Cancer
3. Radiolabeled SMT-487 in Treating Patients With Refractory Small Cell Lung Cancer or Metastatic Breast Cancer
4. Allogeneic Peripheral Stem Cell Transplantation After Antithymocyte Globulin, High-Dose Melphalan, and Fludarabine in Treating Women With Metastatic Adenocarcinoma of the Breast
5. Comparison of Two Regimens of Liposomal Doxorubicin in Treating Women with Metastatic Breast Cancer
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Exemestane Compared With Tamoxifen in Treating Women With Locally Recurrent or Metastatic Breast Cancer
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