Exemestane Compared With Tamoxifen in Treating Women With Locally Recurrent or Metastatic Breast Cancer

NCT00002777 | Completed Phase 3

• 2 other identifiers: EORTC-10951PHARMACIA-EORTC-10951
• Study Type: interventional
• Target: 342
• Locations: 12 countries
• Sites: 48

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.

Conditions

Breast Cancer

Keywords

stage IV breast cancer; recurrent breast cancer

Interventions

exemestane DRUG

tamoxifen citrate DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (48)

Liverpool Hospital

Liverpool, New South Wales, 2170, Australia

Location

Princess Alexandra Hospital

Brisbane, Queensland, 4102, Australia

Location

Austin Hospital

Heidelberg, Victoria, 3084, Australia

Location

Bankstown - Lidcombe Hospital

Bankstown, NSW 2200, Australia

Location

Algemeen Ziekenhuis Middelheim

Antwerp, 2020, Belgium

Location

Institut Jules Bordet

Brussels (Bruxelles), 1000, Belgium

Location

Centre Hospitalier Etterbeek Ixelles

Brussels (Bruxelles), B-1050, Belgium

Location

Hopital de Jolimont

Haine-Saint-Paul, 7100, Belgium

Location

Centre Hospitalier Universitaire de Tivoli

La Louvière, 7100, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

Clinique Sainte Elisabeth

Namur, 5000, Belgium

Location

Algemeen Ziekenhuis Sint-Augustinus

Wilrijk, 2610, Belgium

Location

Institut Bergonie

Bordeaux, 33076, France

Location

Centre Regional Francois Baclesse

Caen, 14076, France

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

Centre de Lutte Contre le Cancer, Georges-Francois Leclerc

Dijon, 21079, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

Centre Eugene Marquis

Rennes, 35064, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Centre Rene Huguenin

Saint-Cloud, 92211, France

Location

University of Malaysia Medical Center

Kuala Lumpur, 59100, Malaysia

Location

Leyenburg Ziekenhuis

's-Gravenhage (Den Haag, the Hague), 2545 CH, Netherlands

Location

Ziekenhuis Eemland de Lichtenberg

Amersfont, 3016 CP, Netherlands

Location

Antoni van Leeuwenhoekhuis

Amsterdam, 1066 CX, Netherlands

Location

Onze Lieve Vrouwe Gasthuis

Amsterdam, 1091 HA, Netherlands

Location

Catharina Ziekenhuis

Eindhoven, 5602 ZA, Netherlands

Location

Leiden University Medical Center

Leiden, 2300 CA, Netherlands

Location

Medisch Centrum Haaglanden Locatle Antoniushove

Leidschendam, 2262 BA, Netherlands

Location

Academisch Ziekenhuis Maastricht

Maastricht, 6202 AZ, Netherlands

Location

University Medical Center Nijmegen

Nijmegen, NL-6500 HB, Netherlands

Location

Waterlandziekenhuis

Purmerend, 1440 AG, Netherlands

Location

Saint Laurentius Ziekenhuis

Roermond, 6043 CV, Netherlands

Location

Rotterdam Cancer Institute

Rotterdam, 3075 EA, Netherlands

Location

Maasland Hospital

Sittard, 6131 BK, Netherlands

Location

St. Elisabeth Ziekenhuis

Tilburg, 5022 GC, Netherlands

Location

Diakonessenhuis Utrecht

Utrecht, 3508 TG, Netherlands

Location

Sint Joseph Ziekenhuis

Veldhoven, 5500 MB DB, Netherlands

Location

Chong Hua Medical Arts Center

Cebu City, 6000, Philippines

Location

Medical University of Gdansk

Gdansk, 80-211, Poland

Location

Russian Academy of Medical Sciences Cancer Research Center

Moscow, 115478, Russia

Location

Petrov Research Institute of Oncology

Saint Petersburg, 197758, Russia

Location

Institute of Oncology, Ljubljana

Ljubljana, Sl-1000, Slovenia

Location

Tri-Service General Hospital

Taipei, NEIHU- 114, Taiwan

Location

Siriraj Hospital

Bangkok, 10700, Thailand

Location

Guy's and St. Thomas' Hospitals Trust

London, England, SE1 9RT, United Kingdom

Location

South Tees Hospitals NHS Trust

Middlesbrough, Cleveland, England, TS4 3BW, United Kingdom

Location

Weston Park Hospital

Sheffield, England, S1O 2SJ, United Kingdom

Location

Western General Hospital

Edinburgh, Scotland, EH4 2XU, United Kingdom

Location

Related Publications (4)

• 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 Organisation for Research and Treatment of Cancer Breast Cancer Cooperative Group. J Clin Oncol. 2008 Oct 20;26(30):4883-90. doi: 10.1200/JCO.2007.14.4659. Epub 2008 Sep 15.

  PMID: 18794551 RESULT

• 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 EORTC Trial 10951, 'Randomized phase II study in first line hormonal treatment for metastatic breast cancer with exemestane or tamoxifen in postmenopausal patients'. Ann Oncol. 2004 Feb;15(2):211-7. doi: 10.1093/annonc/mdh064.

  PMID: 14760111 RESULT

• 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 Clin Oncol 22 (Suppl 14): A-515, 6s, 2004.

  RESULT

• 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 with the exemestane working group and NCIC Clinical Trials Group. [Abstract] Eur J Cancer 2 (Suppl 3): A-241, 126, 2004.

  RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

exemestane; Tamoxifen

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Robert Paridaens, MD, PhD

  University Hospital, Gasthuisberg

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: April 11, 2003
• Study Start: May 1, 1996
• Primary Completion: December 1, 2002
• Last Updated: July 2, 2012

Record last verified: 2012-06

Locations

GB (4); SL (1); TH (1); AU (4); NL (16); PL (1); RU (2); FR (8); BE (8); MY (1); PH (1); TW (1)