Breast Cancer Clinical Trial
Official title:
RANDOMIZED PHASE II STUDY IN FIRST LINE HORMONAL TREATMENT FOR METASTATIC BREAST CANCER WITH EXEMESTANE OR TAMOXIFEN IN POSTMENOPAUSAL PATIENTS
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.
Status | Completed |
Enrollment | 342 |
Est. completion date | |
Est. primary completion date | December 2002 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 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/mm^3 - Platelet count at least 100,000/mm^3 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 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 |
Allocation: Randomized, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Bankstown - Lidcombe Hospital | Bankstown | |
Australia | Princess Alexandra Hospital | Brisbane | Queensland |
Australia | Austin Hospital | Heidelberg | Victoria |
Australia | Liverpool Hospital | Liverpool | New South Wales |
Belgium | Algemeen Ziekenhuis Middelheim | Antwerp | |
Belgium | Centre Hospitalier Etterbeek Ixelles | Brussels (Bruxelles) | |
Belgium | Institut Jules Bordet | 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 | |
France | 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 | |
Malaysia | University of Malaysia Medical Center | Kuala Lumpur | |
Netherlands | 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 | |
Philippines | Chong Hua Medical Arts Center | Cebu City | |
Poland | Medical University of Gdansk | Gdansk | |
Russian Federation | Russian Academy of Medical Sciences Cancer Research Center | Moscow | |
Russian Federation | Petrov Research Institute of Oncology | Saint Petersburg | |
Slovenia | Institute of Oncology, Ljubljana | Ljubljana | |
Taiwan | Tri-Service General Hospital | Taipei | |
Thailand | Siriraj Hospital | Bangkok | |
United Kingdom | Western General Hospital | Edinburgh | Scotland |
United Kingdom | 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 |
Lead Sponsor | Collaborator |
---|---|
European Organisation for Research and Treatment of Cancer - EORTC |
Australia, Belgium, France, Malaysia, Netherlands, Philippines, Poland, Russian Federation, Slovenia, Taiwan, Thailand, United Kingdom,
Atalay G, Dirix L, Biganzoli L, Beex L, Nooij M, Cameron D, Lohrisch C, Cufer T, Lobelle JP, Mattiaci MR, Piccart M, Paridaens R. The effect of exemestane on serum lipid profile in postmenopausal women with metastatic breast cancer: a companion study to E — View Citation
Paridaens R, Therasse P, Dirix L, et al.: First line hormonal treatment (HT) for metastatic breast cancer (MBC) with exemestane (E) or tamoxifen (T) in postmenopausal patients (pts): A randomized phase III trial of the EORTC Breast group. [Abstract] J Cli
Paridaens R, Therasse P, Dirix L, et al.: First results of a randomized phase III trial comparing exemestane versus tamoxifen as first-line hormone therapy (HT) for postmenopausal women with metastatic breast cancer (MBC) : EORTC 10951 in collaboration wi
Paridaens RJ, Dirix LY, Beex LV, Nooij M, Cameron DA, Cufer T, Piccart MJ, Bogaerts J, Therasse P. Phase III study comparing exemestane with tamoxifen as first-line hormonal treatment of metastatic breast cancer in postmenopausal women: the European Organ — View Citation
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