AzTrials
AzTrials

Breast NeoplasmsPhase 3IESNCT00038467

Randomized Trial Of Exemestane Versus Continued Tamoxifen In Postmenopausal Women With Early Breast Cancer

A Phase 3 study testing Tamoxifen and Exemestane in people with Breast Neoplasms, run by Pfizer at 377 sites in 37 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

To compare the sequential administration of exemestane with administration of further tamoxifen until 5 years in postmenopausal women with operable breast cancer who have already received 2-3 years of adjuvant tamoxifen, in terms of disease-free survival (DFS), overall survival (OS), incidence of contralateral breast… Read more about this study

Who is it for?
Ages 30 years and older, women only
Conditions the study is for
Breast Neoplasms
What is being tested?
Tamoxifen and Exemestane
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,740 participants
Where
377 sitesin 37 countries
Study dates
Feb 1998to Mar 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • postmenopausal women with histologically or cytologically confirmed primary breast adenocarcinoma, receiving tamoxifen and have been treated with tamoxifen continuously for between 2 and 3 years and one month, and still free of disease

Who cannot join

  • unresectable breast cancer
  • ER negative primary tumor

Trial locations and contacts

377 sites in 37 countries.

377 sites in 37 countries

United States57 sites

  • Pfizer Investigational Site

    Albany, New York, 12206

  • Pfizer Investigational Site

    Arlington, Texas, 76014-2084

  • Pfizer Investigational Site

    Bedford, Texas, 76022

  • Pfizer Investigational Site

    Birmingham, Alabama, 35205

  • Pfizer Investigational Site

    Birmingham, Alabama, 35213

  • Pfizer Investigational Site

    Birmingham, Alabama, 35235

  • Pfizer Investigational Site

    Boulder, Colorado, 80304

  • Pfizer Investigational Site

    Cedar Rapids, Iowa, 52403

  • Pfizer Investigational Site

    Colorado Springs, Colorado, 80909

  • Pfizer Investigational Site

    Dallas, Texas, 75230-2510

  • Pfizer Investigational Site

    Dallas, Texas, 75231

  • Pfizer Investigational Site

    Dallas, Texas, 75246

  • Pfizer Investigational Site

    Denver, Colorado, 80218

  • Pfizer Investigational Site

    El Paso, Texas, 79902

  • Pfizer Investigational Site

    El Paso, Texas, 79915

  • Pfizer Investigational Site

    Fishers, Indiana, 46037

  • Pfizer Investigational Site

    Fishers, Indiana, 46038

  • Pfizer Investigational Site

    Fort Collins, Colorado, 80528

  • Pfizer Investigational Site

    Garland, Texas, 75042

  • Pfizer Investigational Site

    Green Valley, Arizona, 85614

  • Pfizer Investigational Site

    Green Velley, Arizona, 85614

  • Pfizer Investigational Site

    Houston, Texas, 77024

  • Pfizer Investigational Site

    Houston, Texas, 77029

  • Pfizer Investigational Site

    Houston, Texas, 77030

  • Pfizer Investigational Site

    Houston, Texas, 77074

  • Pfizer Investigational Site

    Indianapolis, Indiana, 46219

  • Pfizer Investigational Site

    Indianapolis, Indiana, 46227

  • Pfizer Investigational Site

    Indianapolis, Indiana, IN 46219

  • Pfizer Investigational Site

    Jacksonville, Florida, 32204

  • Pfizer Investigational Site

    Jacksonville, Florida, 32207

  • Pfizer Investigational Site

    Jacksonville Beach, Florida, 32250

  • Pfizer Investigational Site

    Lakewood, Colorado, 80228

  • Pfizer Investigational Site

    Latham, New York, 12110-0610

  • Pfizer Investigational Site

    Longview, Texas, 75601

  • Pfizer Investigational Site

    McAllen, Texas, 78503

  • Pfizer Investigational Site

    Mesquite, Texas, 75150

  • Pfizer Investigational Site

    Ocala, Florida, 34474

  • Pfizer Investigational Site

    Odessa, Texas, 79761

  • Pfizer Investigational Site

    Orange Park, Florida, 32073

  • Pfizer Investigational Site

    Pasadena, Texas, 77502

  • Pfizer Investigational Site

    Pittsfield, Massachusetts, 01201

  • Pfizer Investigational Site

    Plano, Texas, 75075-7787

  • Pfizer Investigational Site

    Portland, Oregon, 97225

  • Pfizer Investigational Site

    Portland, Oregon, 97227

  • Pfizer Investigational Site

    San Antonio, Texas, 78217

  • Pfizer Investigational Site

    Sherman, Texas, 75090

  • Pfizer Investigational Site

    Spokane, Washington, 99202

  • Pfizer Investigational Site

    Spokane, Washington, 99218

  • Pfizer Investigational Site

    Sugar Land, Texas, 77479

  • Pfizer Investigational Site

    Thornton, Colorado, 80260

  • Pfizer Investigational Site

    Tucson, Arizona, 85704

  • Pfizer Investigational Site

    Tucson, Arizona, 85710

  • Pfizer Investigational Site

    Tucson, Arizona, 85712

  • Pfizer Investigational Site

    Tucson, Arizona, 85715

  • Pfizer Investigational Site

    Tucson, Arizona, 85745

  • Pfizer Investigational Site

    Tyler, Texas, 75702

  • Pfizer Investigational Site

    Weslaco, Texas, 78596

Other trials in United States

Italy41 sites

  • Pfizer Investigational Site

    Alba (CN), 12051

  • Pfizer Investigational Site

    Aviano (PN), 33081

  • Pfizer Investigational Site

    Bergamo, 24128

  • Pfizer Investigational Site

    Biella, 13900

  • Pfizer Investigational Site

    Cagliari, 09121

  • Pfizer Investigational Site

    Carpi, Modena, 41012

  • Pfizer Investigational Site

    Casale Monferrato, AL, 15033

  • Pfizer Investigational Site

    Correggio, 42015

  • Pfizer Investigational Site

    Cremona, 26100

  • Pfizer Investigational Site

    Cuneo, 12100

  • Pfizer Investigational Site

    Fermo FM, 63023

  • Pfizer Investigational Site

    Florence, 50134

  • Pfizer Investigational Site

    Genova, 16128

  • Pfizer Investigational Site

    Genova, 16132

  • Pfizer Investigational Site

    Lecco, 23900

  • Pfizer Investigational Site

    Lodi, 20075

  • Pfizer Investigational Site

    Mantua, 46100

  • Pfizer Investigational Site

    Milan, 20121

  • Pfizer Investigational Site

    Milan, 20133

  • Pfizer Investigational Site

    Milan, 20141

  • Pfizer Investigational Site

    Milan, 21053

  • Pfizer Investigational Site

    Modena, 41100

  • Pfizer Investigational Site

    Monserrato (CA), 09042

  • Pfizer Investigational Site

    Monza, 20052

  • Pfizer Investigational Site

    Naples, 80131

  • Pfizer Investigational Site

    Palermo, 90139

  • Pfizer Investigational Site

    Parma, 43100

  • Pfizer Investigational Site

    Perugia, 06132

  • Pfizer Investigational Site

    Piacenza, 29100

  • Pfizer Investigational Site

    Pietra Ligure (SV), 17027

  • Pfizer Investigational Site

    Pisa, 56100

  • Pfizer Investigational Site

    Reggio Emilia, 42100

  • Pfizer Investigational Site

    Roma, 00148

  • Pfizer Investigational Site

    Sassari, 07100

  • Pfizer Investigational Site

    Terni, 05100

  • Pfizer Investigational Site

    Thiene (VI), 36016

  • Pfizer Investigational Site

    Torino, 10126

  • Pfizer Investigational Site

    Tortona, 15057

  • Pfizer Investigational Site

    Trescore Balneario BG, 24069

  • Pfizer Investigational Site

    Treviglio (BG), 24047

  • Pfizer Investigational Site

    Varese, 21100

Other trials in Italy

United Kingdom40 sites

  • Pfizer Investigational Site

    Bangor, Gwynedd, LL57 2PW

  • Pfizer Investigational Site

    Belfast, BT97AB

  • Pfizer Investigational Site

    Bournemouth, Dorset, BH7 7DW

  • Pfizer Investigational Site

    Bradford, BD9 6RJ

  • Pfizer Investigational Site

    Bristol, BS10 5NB

  • Pfizer Investigational Site

    Cardiff, CF14 2TL

  • Pfizer Investigational Site

    Coventry, CV2 2DX

  • Pfizer Investigational Site

    East Kilbride, G75 8RG

  • Pfizer Investigational Site

    Epping, Essex, CM166TN

  • Pfizer Investigational Site

    Gosport, Hants, PO12 2AA

  • Pfizer Investigational Site

    Harrogate, N. Yorkshire, HG2 7SX

  • Pfizer Investigational Site

    Huddersfield, HD3 3EA

  • Pfizer Investigational Site

    Hull, East Yorkshire, HU16 5JQ

  • Pfizer Investigational Site

    Huntingdon, Cambs, PE18 8NT

  • Pfizer Investigational Site

    Leeds, LS1 3EX

  • Pfizer Investigational Site

    Leeds, LS9 7TF

  • Pfizer Investigational Site

    Lincoln

  • Pfizer Investigational Site

    London, N18 1QX

  • Pfizer Investigational Site

    London, N19 5NF

  • Pfizer Investigational Site

    London, NW3 2QG

  • Pfizer Investigational Site

    London, SW17 0QT

  • Pfizer Investigational Site

    London, W6 8RF

  • Pfizer Investigational Site

    Londonderry, Northern Ireland, BT47 1SB

  • Pfizer Investigational Site

    Luton, LU4 0DZ

  • Pfizer Investigational Site

    Manchester, M20 4BX

  • Pfizer Investigational Site

    Newport, Gwent, NP6 2UB

  • Pfizer Investigational Site

    Northwood, Middlesex, HA6 2RN

  • Pfizer Investigational Site

    Salterhebble, Halifax, HX6 0PW

  • Pfizer Investigational Site

    Sheffield, S10 2SJ

  • Pfizer Investigational Site

    Shrewsbury

  • Pfizer Investigational Site

    Somerset, BA21 4AT

  • Pfizer Investigational Site

    Southampton, S016 6YD

  • Pfizer Investigational Site

    Steeton, BD20 6TD

  • Pfizer Investigational Site

    Stoke-on-Trent, ST4 6QG

  • Pfizer Investigational Site

    Swansea, South Wales, SA2 8QA

  • Pfizer Investigational Site

    Taunton, Somerset, TA1 5DA

  • Pfizer Investigational Site

    Telford, TF1 6TF

  • Pfizer Investigational Site

    Westcliff-on-Sea, Essex, SS0 0RY

  • Pfizer Investigational Site

    Wythenshawe, Manchester, M23 9LT

  • Pfizer Investigational Site

    York, Yorkshire, Y03 7He

Other trials in United Kingdom

France29 sites

  • Pfizer Investigational Site

    Angers, 49033 Cedex 01

  • Pfizer Investigational Site

    Annecy, 74011

  • Pfizer Investigational Site

    Avignon, 84082

  • Pfizer Investigational Site

    Bordeaux, France, 33030 Cedex

  • Pfizer Investigational Site

    Bordeaux, France, 33300 Cedex

  • Pfizer Investigational Site

    Brest, 29609 Cedex

  • Pfizer Investigational Site

    Caen, 14052 Cedex

  • Pfizer Investigational Site

    Caen, 14076

  • Pfizer Investigational Site

    Clermont-Ferrand, 63011

  • Pfizer Investigational Site

    Évreux, 27000

  • Pfizer Investigational Site

    Lagny-sur-Marne, 77405 Cedex

  • Pfizer Investigational Site

    Le Havre, 76600

  • Pfizer Investigational Site

    Le Mans, 72000

  • Pfizer Investigational Site

    Lille, 59020 Cedex

  • Pfizer Investigational Site

    Lyon, 69373

  • Pfizer Investigational Site

    Marseille, 13273

  • Pfizer Investigational Site

    Meaux, 77100

  • Pfizer Investigational Site

    Montbéliard, 25209 Cedex

  • Pfizer Investigational Site

    Mulhouse, 68070 Cedex

  • Pfizer Investigational Site

    Nice, 06189

  • Pfizer Investigational Site

    Paris, 75248 Cedex 5

  • Pfizer Investigational Site

    Paris, 75970 Cedex 20

  • Pfizer Investigational Site

    Perpignan, 66046

  • Pfizer Investigational Site

    Rennes, 35042

  • Pfizer Investigational Site

    Rouen, 76038 Cedex

  • Pfizer Investigational Site

    Saint-Cloud, 92210

  • Pfizer Investigational Site

    Saint-Herblain, 44805

  • Pfizer Investigational Site

    Strasbourg, 67091 Cedex

  • Pfizer Investigational Site

    Toulouse, 31502

Other trials in France

Netherlands23 sites

  • Pfizer Investigational Site

    Amersfoort, 3818 ES

  • Pfizer Investigational Site

    Amsterdam, 1061 AE

  • Pfizer Investigational Site

    Amsterdam, 1066 CX

  • Pfizer Investigational Site

    Amsterdam, 1105 AZ

  • Pfizer Investigational Site

    Apeldoorn, 7300 DS

  • Pfizer Investigational Site

    Blaricum, 1261 AN

  • Pfizer Investigational Site

    Breda, 4818 CK

  • Pfizer Investigational Site

    Delft, 2625 AD

  • Pfizer Investigational Site

    Eindhoven, 5623 EJ

  • Pfizer Investigational Site

    Enschede, 7513 ER

  • Pfizer Investigational Site

    Groningen, 9700 RM

  • Pfizer Investigational Site

    Groningen, 9728 NZ

  • Pfizer Investigational Site

    Hengelo, 7555 DL

  • Pfizer Investigational Site

    Leeuwarden, 8934 AD

  • Pfizer Investigational Site

    Leiden, 2333 ZA

  • Pfizer Investigational Site

    Leidschendam, 2262 BA

  • Pfizer Investigational Site

    Podybus 90153, 5200 ME Den Bosch

  • Pfizer Investigational Site

    Roermond, 6043 CV

  • Pfizer Investigational Site

    Sittard, 6131 BK

  • Pfizer Investigational Site

    The Hague, 2545 CH

  • Pfizer Investigational Site

    Utrecht, 3582 KE

  • Pfizer Investigational Site

    Veldhoven, 5504 DB

  • Pfizer Investigational Site

    Zaandam, 1502 DV

Other trials in Netherlands

Spain22 sites

  • Pfizer Investigational Site

    Albacete, Albacete, 02006

  • Pfizer Investigational Site

    Alcoy, Alicante, 03804

  • Pfizer Investigational Site

    Alicante, Alicante, 03010

  • Pfizer Investigational Site

    Badajoz, Badajoz, 06008

  • Pfizer Investigational Site

    Badajoz, Badajoz, 06080

  • Pfizer Investigational Site

    Badalona, Barcelona, 08911

  • Pfizer Investigational Site

    Badalona, Barcelona, 08916

  • Pfizer Investigational Site

    Barbastro, Huesca, 22300

  • Pfizer Investigational Site

    Córdoba, Cordoba, 14004

  • Pfizer Investigational Site

    Donostia / San Sebastian, Guipuzcoa, 20014

  • Pfizer Investigational Site

    Elche, Alicante, 03203

  • Pfizer Investigational Site

    Guadalajara, Guadalajara, 19002

  • Pfizer Investigational Site

    Lleida, Lleida, 25198

  • Pfizer Investigational Site

    Madrid, Madrid, 28034

  • Pfizer Investigational Site

    Madrid, Madrid, 28040

  • Pfizer Investigational Site

    Madrid, Madrid, 28041

  • Pfizer Investigational Site

    Reus, Tarragona, 43201

  • Pfizer Investigational Site

    Sant Joan d'Alacant, Alicante, 03550

  • Pfizer Investigational Site

    Terrassa, Barcelona, 08221

  • Pfizer Investigational Site

    Terrassa, Barcelona, 08227

  • Pfizer Investigational Site

    Valencia, Valencia, 46014

  • Pfizer Investigational Site

    Zaragoza, Zaragoza, 50009

Other trials in Spain

Belgium19 sites

  • Pfizer Investigational Site

    Antwerp, 2020

  • Pfizer Investigational Site

    Arlon, 6700

  • Pfizer Investigational Site

    Baudour, 7331

  • Pfizer Investigational Site

    Brasschaat, 2930

  • Pfizer Investigational Site

    Brussels, 1000

  • Pfizer Investigational Site

    Brussels, 1180

  • Pfizer Investigational Site

    Charleroi, 6000

  • Pfizer Investigational Site

    Edegem, 2650

  • Pfizer Investigational Site

    Genk, 3600

  • Pfizer Investigational Site

    Haine-Saint-Paul, 7100

  • Pfizer Investigational Site

    Hasselt, 3500

  • Pfizer Investigational Site

    Kraainem, 1950

  • Pfizer Investigational Site

    La Louvière, 7100

  • Pfizer Investigational Site

    Leuven, 3000

  • Pfizer Investigational Site

    Liège, 4000

  • Pfizer Investigational Site

    Merksem, 2170

  • Pfizer Investigational Site

    Namur, 5000

  • Pfizer Investigational Site

    Verviers, 4800

  • Pfizer Investigational Site

    Wilrijk, 2610

Other trials in Belgium

Germany19 sites

  • Pfizer Investigational Site

    Berlin, 10117

  • Pfizer Investigational Site

    Berlin, 13353

  • Pfizer Investigational Site

    Chemnitz, 09126

  • Pfizer Investigational Site

    Erlangen, 91054

  • Pfizer Investigational Site

    Freiburg im Breisgau, 79106

  • Pfizer Investigational Site

    Gera, 07548

  • Pfizer Investigational Site

    Greiz, 07973

  • Pfizer Investigational Site

    Halle, 06110

  • Pfizer Investigational Site

    Halle, 06120

  • Pfizer Investigational Site

    Hamburg, 22081

  • Pfizer Investigational Site

    Hildburghausen, 98646

  • Pfizer Investigational Site

    Leipzig, 04129

  • Pfizer Investigational Site

    Lübeck, 23538

  • Pfizer Investigational Site

    München, 80335

  • Pfizer Investigational Site

    Riesa, 01589

  • Pfizer Investigational Site

    Rodewisch, 08228

  • Pfizer Investigational Site

    Saarbrücken, 66113

  • Pfizer Investigational Site

    Suhl, 98527

  • Pfizer Investigational Site

    Weiden, 92637

Other trials in Germany

Sweden16 sites

  • Pfizer Investigational Site

    Borås, Sweden, 50182

  • Pfizer Investigational Site

    Borås, 501 82

  • Pfizer Investigational Site

    Gothenburg, 413 45

  • Pfizer Investigational Site

    Halmstad, 301 85

  • Pfizer Investigational Site

    Helsingborg, 251 87

  • Pfizer Investigational Site

    Kristianstad, 291 85

  • Pfizer Investigational Site

    Linköping, 581 85

  • Pfizer Investigational Site

    Lund, 221 85

  • Pfizer Investigational Site

    Malmö, 205 02

  • Pfizer Investigational Site

    Motala, 591 85

  • Pfizer Investigational Site

    Nässjö, 575 81

  • Pfizer Investigational Site

    Norrköping, 601 82

  • Pfizer Investigational Site

    Värnamo, 331 85

  • Pfizer Investigational Site

    Västerås, 721 89

  • Pfizer Investigational Site

    Västervik, 59381

  • Pfizer Investigational Site

    Vaxjo, 351 85

Other trials in Sweden

Norway14 sites

  • Pfizer Investigational Site

    Bergen, 5021

  • Pfizer Investigational Site

    Bodø, 8092

  • Pfizer Investigational Site

    Fredrikstad, 1603

  • Pfizer Investigational Site

    Haugesund, 5390

  • Pfizer Investigational Site

    Levanger, 7600

  • Pfizer Investigational Site

    Mo i Rana, 8607

  • Pfizer Investigational Site

    Molde, 6407

  • Pfizer Investigational Site

    Notodden, 3674

  • Pfizer Investigational Site

    Oslo

  • Pfizer Investigational Site

    Rissa, 7100

  • Pfizer Investigational Site

    Rjukan, 3660

  • Pfizer Investigational Site

    Sandefjord

  • Pfizer Investigational Site

    Tønsberg, 3103

  • Pfizer Investigational Site

    Tromsø, 9038

Other trials in Norway

Argentina12 sites

  • Pfizer Investigational Site

    Buenos Aires, Buenos Aires F.D., 1406

  • Pfizer Investigational Site

    Buenos Aires, Buenos Aires F.D., 1417

  • Pfizer Investigational Site

    Buenos Aires, Buenos Aires F.D., 1425

  • Pfizer Investigational Site

    Buenos Aires, Buenos Aires F.D., 1426

  • Pfizer Investigational Site

    Buenos Aires, Buenos Aires F.D.

  • Pfizer Investigational Site

    Buenos Aires, 1181

  • Pfizer Investigational Site

    Córdoba, X5000AA1

  • Pfizer Investigational Site

    Haedo, Buenos Aires, 1706

  • Pfizer Investigational Site

    Rosario, Pcia. de Santa Fe

  • Pfizer Investigational Site

    Rosario, Santa Fe Province, 2000

  • Pfizer Investigational Site

    San Isidro, Buenos Aires, 1642

  • Pfizer Investigational Site

    San Martín, Buenos Aires, 1650

Other trials in Argentina

Denmark10 sites

  • Pfizer Investigational Site

    Aarhus C, 8000

  • Pfizer Investigational Site

    Esbjerg, 6700

  • Pfizer Investigational Site

    Herlev, 2730

  • Pfizer Investigational Site

    Herning, 7400

  • Pfizer Investigational Site

    Hilleroed, 3400

  • Pfizer Investigational Site

    Koebenhavn OE, 2100

  • Pfizer Investigational Site

    Næstved, 4700

  • Pfizer Investigational Site

    Roskilde, 4000

  • Pfizer Investigational Site

    Vejle, 7100

  • Pfizer Investigational Site

    Viborg, 8800

Other trials in Denmark

Poland9 sites

  • Pfizer Investigational Site

    Gdansk, 80-952

  • Pfizer Investigational Site

    Gliwice, 44-101

  • Pfizer Investigational Site

    Krakow, 31-115

  • Pfizer Investigational Site

    Krakow, 31-826

  • Pfizer Investigational Site

    Lodz, 93-509

  • Pfizer Investigational Site

    Opole, 45-060

  • Pfizer Investigational Site

    Poznan, 61-878

  • Pfizer Investigational Site

    Sopot, 81-756

  • Pfizer Investigational Site

    Warsaw, 02-781

Other trials in Poland

Australia8 sites

  • Pfizer Investigational Site

    Adelaide, South Australia, 5000

  • Pfizer Investigational Site

    Bendigo, Victoria, 3552

  • Pfizer Investigational Site

    Box Hill, Victoria, 3128

  • Pfizer Investigational Site

    Camperdown, New South Wales, 2050

  • Pfizer Investigational Site

    Dubbo, New South Wales, 2830

  • Pfizer Investigational Site

    Liverpool, New South Wales, 2170

  • Pfizer Investigational Site

    Ringwood East, Victoria, 3135

  • Pfizer Investigational Site

    Waratah, New South Wales, 2298

Other trials in Australia

Israel7 sites

  • Pfizer Investigational Site

    Haifa, 34362

  • Pfizer Investigational Site

    Haifa

  • Pfizer Investigational Site

    Jerusalem, 91120

  • Pfizer Investigational Site

    Jerusalem

  • Pfizer Investigational Site

    Kfar Saba

  • Pfizer Investigational Site

    Petah Tikva

  • Pfizer Investigational Site

    Rehovot

Other trials in Israel

Bulgaria5 sites

  • Pfizer Investigational Site

    Plovdiv, 4004

  • Pfizer Investigational Site

    Sofia, 1504

  • Pfizer Investigational Site

    Sofia, 1756

  • Pfizer Investigational Site

    Sofia, 1784

  • Pfizer Investigational Site

    Stara Zagora, 6003

Other trials in Bulgaria

Switzerland5 sites

  • Pfizer Investigational Site

    Basel, CH-4031

  • Pfizer Investigational Site

    Bellinzona, CH-6500

  • Pfizer Investigational Site

    Bern, 3010

  • Pfizer Investigational Site

    Bern, CH-3012

  • Pfizer Investigational Site

    Geneva, CH-1211

Other trials in Switzerland

Croatia4 sites

  • Pfizer Investigational Site

    Osijek

  • Pfizer Investigational Site

    Split

  • Pfizer Investigational Site

    Zagreb, 10000

  • Pfizer Investigational Site

    Zagreb

Other trials in Croatia

Ireland4 sites

  • Pfizer Investigational Site

    Cork

  • Pfizer Investigational Site

    Cork, Ireland

  • Pfizer Investigational Site

    Dublin

  • Pfizer Investigational Site

    Galway

Other trials in Ireland

Czechia3 sites

  • Pfizer Investigational Site

    Brno, 656 53

  • Pfizer Investigational Site

    České Budějovice, 370 87

  • Pfizer Investigational Site

    Prague, 12808

Other trials in Czechia

Greece3 sites

  • Pfizer Investigational Site

    Athens, Attica, 115 22

  • Pfizer Investigational Site

    Athens, Attica, 115 28

  • Pfizer Investigational Site

    Heraklion, Crete, 71 110

Other trials in Greece

Hungary3 sites

  • Pfizer Investigational Site

    Budapest, 1082

  • Pfizer Investigational Site

    Budapest, 1122

  • Pfizer Investigational Site

    Budapest, 1145

Other trials in Hungary

Portugal3 sites

  • Pfizer Investigational Site

    Coimbra, 3040

  • Pfizer Investigational Site

    Coimbra

  • Pfizer Investigational Site

    Evora, 7000-811

Other trials in Portugal

Romania3 sites

  • Pfizer Investigational Site

    Bucharest, 72435

  • Pfizer Investigational Site

    Cluj-Napoca, 400015

  • Pfizer Investigational Site

    Timișoara, 300223

Other trials in Romania

Slovakia3 sites

  • Pfizer Investigational Site

    Banská Bystrica, 97517

  • Pfizer Investigational Site

    Bratislava, SK-83310

  • Pfizer Investigational Site

    Košice, 041 90

Other trials in Slovakia

New Zealand2 sites

  • Pfizer Investigational Site

    Auckland, 1142

  • Pfizer Investigational Site

    Hamilton, Waikato Region, 2021

Other trials in New Zealand

Serbia2 sites

  • Pfizer Investigational Site

    Belgrade, 11000

  • Pfizer Investigational Site

    Kamenitz, Serbia, 21204

Other trials in Serbia

South Africa2 sites

  • Pfizer Investigational Site

    Johannesburg, Gauteng, 2196

  • Pfizer Investigational Site

    Observatory, 7925

Other trials in South Africa

Bosnia and Herzegovina1 site

  • Pfizer Investigational Site

    Sarajevo, 71000

Other trials in Bosnia and Herzegovina

Egypt1 site

  • Pfizer Investigational Site

    Cairo

Other trials in Egypt

Estonia1 site

  • Pfizer Investigational Site

    Tartu, 51014

Other trials in Estonia

Hong Kong1 site

  • Pfizer Investigational Site

    New Territories

Other trials in Hong Kong

Luxembourg1 site

  • Pfizer Investigational Site

    Luxembourg, 1210

Other trials in Luxembourg

Malta1 site

  • Pfizer Investigational Site

    Floriana, VLT 14

Other trials in Malta

Peru1 site

  • Pfizer Investigational Site

    Lima, Lima Province, L34

Other trials in Peru

Russia1 site

  • Pfizer Investigational Site

    Saint Petersburg, 197758

Other trials in Russia

Slovenia1 site

  • Pfizer Investigational Site

    Ljubljana, 1000

Other trials in Slovenia

About this study

Official title: Randomized Double-Blind Trial In Postmenopausal Women With Primary Breast Cancer Who Have Received Adjuvant Tamoxifen For 2-3 Years, Comparing Subsequent Adjuvant Exemestane Treatment With Further Tamoxifen

To compare the sequential administration of exemestane with administration of further tamoxifen until 5 years in postmenopausal women with operable breast cancer who have already received 2-3 years of adjuvant tamoxifen, in terms of disease-free survival (DFS), overall survival (OS), incidence of contralateral breast cancer and long-term tolerability.

Being tested
Tamoxifen, Exemestane
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TamoxifenDrug

    Tamoxifen 20 mg/day tablets administered p.o. for a period ranging from 2.5 to 3 years.

  • ExemestaneDrug

    Exemestane 25 mg/day tablets administered p.o. for a period ranging from 2.5 to 3 years.

Study groups in NCT00038467
Study groupRoleWhat they receive
BActive comparatorNot described
Receives: Drug: Tamoxifen
AExperimentalNot described
Receives: Drug: Exemestane

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease-Free Survival (DFS) at Month 36 Post-Randomization: Main Study

    DFS defined as time from randomization to earliest documentation of breast cancer relapse or death from any cause. DFS at Month 36 post-randomization was defined as probability of participants alive and disease-free at 36 months after the randomization. Participants withdrawn from the study for any reason in the absence of relapse were censored at the date they were last seen. Relapse was categorized as follows: loco-regional: ipsilateral breast or axillary nodal relapse; distant: distant relapse, including supraclavicular nodes; second primary breast cancer: contralateral breast cancer, excluding ductal carcinoma in situ.

    Measured: Baseline up to Month 36

Secondary outcomes (27)

  1. Overall Survival (OS) at Month 36 Post-Randomization: Main Study

    OS was defined as the duration from randomization to death (due to any cause). OS at Month 36 post-randomization was defined as probability of participants' survival at 36 months after the randomization. For participants who were alive, OS was censored at the last available assessment. Probability of OS at Month 36 post-randomization was reported using Kaplan-Meier estimates at Month 36 post-randomization based on 120-month follow-up data.

    Measured: Baseline up to Month 120

  2. Number of Events of Second Breast Cancer in Contralateral Breast: Main Study

    Number of events of second primary breast cancer in contralateral breast (excluding ductal carcinoma in situ) were reported.

    Measured: Baseline up to Month 120

  3. Percent Change From Baseline in Lumbar Spine and Proximal Femur (Total Hip) Bone Mineral Density (BMD) at 6, 12, 24 Months On-treatment and 24 Months Post-treatment: Bone Metabolism Sub-study

    BMD measurements for Lumbar spine (LS) and Proximal Femur (Total Hip [TH]) were performed using dual energy X-ray absorptiometry (DXA) for participants who entered the bone-metabolism sub-study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.

    Measured: Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment

  4. Percent Change From Baseline in Femoral Neck and Femoral Wards Bone Mineral Density (BMD) at 6, 12 and 24 Months On-treatment and 24 Months Post-treatment: Bone Metabolism Sub-study

    BMD measurements for femoral neck (FN) and femoral wards (FW) were performed using dual energy X-ray absorptiometry (DXA) for participants who entered the bone-metabolism sub-study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.

    Measured: Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment

  5. Change From Baseline in Lumbar Spine and Proximal Femur (Total Hip) Bone Mineral Density (BMD) T-scores at 6, 12 and 24 Months On-treatment and 24 Months Post-treatment: Bone Metabolism Sub-study

    BMD measurements for Lumbar spine (LS) and Proximal Femur (Total Hip [TH]) were performed using dual energy X-ray absorptiometry (DXA) for participants who entered the bone-metabolism sub-study. Results were scored as T-score. T-score indicated how many standard deviations higher or lower participant's value was when compared to the young normal reference mean. Using the World Health Organization (WHO) criteria for osteoporosis, a T-score of greater than or equal to (>=)-1.0 was classified as normal, a T-score of greater than -2.5 to less than -1.0 as osteopenic, and a T-score less than or equal to (<=)-2.5 as osteoporotic. Here 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.

    Measured: Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment

  6. Percentage of Bone Specific Alkaline Phosphatase (BAP) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study

    Bone specific alkaline phosphatase (BAP) serum concentration analyzed using enzyme immuno assay (EIA) at post-baseline time points was expressed as percentage of baseline BAP serum concentration. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.

    Measured: Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment

  7. Percentage of C-Terminal Telopeptide (CTX) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study

    C-terminal telopeptide (CTX) serum concentration analyzed using competitive enzyme-linked immunosorbent assay (ELISA) at post-baseline time points was expressed as percentage of baseline CTX serum concentration. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.

    Measured: Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment

  8. Percentage of Osteocalcin (OC) and Procollagen T1 C-Peptide (PICP) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study

    Osteocalcin (OC) serum concentration analyzed using ELISA and procollagen T1 c-peptide (PICP) serum concentration analyzed using sandwich EIA at post-baseline time points was expressed as percentage of baseline OC serum concentration and baseline PICP serum concentration, respectively. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points, for each group respectively.

    Measured: Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment

  9. Percentage of Deoxy-pyridinoline (DPD) Urine Concentration Relative to Baseline: Bone Metabolism Sub-study

    Deoxy-pyridinoline (DPD) urine concentration (adjusted for urinary creatinine) analyzed using competitive EIA at post-baseline time points was expressed as percentage of baseline DPD urine concentration. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.

    Measured: Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment

  10. Percentage of N-telopeptide of Type 1 Collagen (NTX) Urine Concentration Relative to Baseline: Bone Metabolism Sub-study

    N-telopeptide of Type 1 collagen (NTX) urine concentration (adjusted for urinary creatinine) analyzed using competitive inhibition EIA at post-baseline time points was expressed as percentage of baseline NTX urine concentration. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.

    Measured: Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment

  11. Number of Participants With Fracture: Bone Metabolism Sub-study

    Measured: Baseline up to 24 months post-treatment

  12. Change From Baseline in Treatment Outcome Index (TOI) at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study

    The TOI was defined as the sum of 23 items based on following Functional Assessment of Cancer Therapy - Breast version [FACT-B] subscales: Physical well-being (7 items), Functional well-being (7 items), Breast cancer subscale (9 items). Each item was scaled from 0='Not at all' to 4='Very much'. Total TOI score ranged from 0 to 92, where higher TOI score indicated better health-related quality of life (QoL). A change of five points in the TOI scores was considered clinically meaningful. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.

    Measured: Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization

  13. Change From Baseline in Functional Assessment of Cancer Therapy - Endocrine Subscale (FACT-ES) Total Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study

    The FACT-ES assessed health-related QoL in participants with breast cancer. ES subscale comprised of 18 items (hot flushes,cold sweats,night sweats, vaginal discharge,vaginal irritation,vaginal bleeding,vaginal dryness,discomfort with intercourse,lost interest in sex,gained weight,light headed/dizzy,vomiting,had diarrhea,headaches,felt bloated,breast tenderness,mood swings, felt irritable).Participants indicated how true a statement was for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equated to a good QoL. Total FACT-ES score was calculated as sum of all the 18 items and ranged from 0 to 72, where higher score indicated better QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.

    Measured: Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization

  14. Change From Baseline in Total Functional Assessment of Cancer Therapy - General Breast and Endocrine (FACT-GBE) Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study

    FACT-GBE assessed health-related quality of life (QoL) in participants with breast cancer. It consisted of 56 items,summarized to 7 subscales(subscale 1 to 6 constituted total FACT-B and subscale 7 constituted total ES):physical well-being(7 items), social/family well-being(7 items),relationship with doctor (2 items),emotional well-being(6 items),functional well-being(7 items),breast cancer subscale(9 items),endocrine symptoms(18 items). Participants indicated how true a statement had been for them using 5-point scale from 0(not at all) to 4(very much). For items that were negatively framed,scores were reversed for analysis so that higher scores equated to good QoL. Total FACT-GBE score=sum of all 56 items(range 0 to 224, where higher score indicated better QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.

    Measured: Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization

  15. Change From Baseline in Physical Well-Being (PWB) Subscale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study

    The PWB subscale assessed physical well-being related QoL in participants with breast cancer. PWB subscale comprised of 7 items (energy lack, nausea, family needs, pain, side effects, felt ill, forced to stay in bed). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equated to a good QoL. Total PWB score was calculated as the sum of all the 7 items and ranged from 0 to 28, where higher score indicated better physical well-being related QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.

    Measured: Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization

  16. Change From Baseline in Social/Family Well-Being (SWB) Sub-scale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study

    The SWB subscale assessed social/family well-being related QoL in participants with breast cancer. SWB subscale comprised of 7 items (distant from friends, emotional support, support from friends, family acceptance, family communication, close to main support, sexual satisfaction). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equated to a good QoL. Total SWB score was calculated as the sum of all the 7 items and ranged from 0 to 28, where higher score indicated better social/family well-being related QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.

    Measured: Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization

  17. Change From Baseline in Relationship With Doctor (RWD) Subscale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Substudy

    The RWD subscale assessed relationship with doctor in participants with breast cancer. RWD subscale comprised of 2 items (confidence in doctors, doctor answered questions). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). Total RWD score was calculated as the sum of the 2 items and ranged from 0 to 8, where higher score indicated better relationship with doctor. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.

    Measured: Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization

  18. Change From Baseline in Emotional Well-Being (EWB) Subscale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study

    The EWB subscale assessed emotional well-being related QoL in participants with breast cancer. EWB subscale comprised of 6 items (felt sad, proud of coping, lost hope, felt nervous, worried about dying, worried about condition worsening). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equate to a good QoL. Total EWB score was calculated as the sum of the 6 items and ranged from 0 to 24, where higher score indicated better emotional well-being related QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.

    Measured: Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization

  19. Change From Baseline in Functional Well-Being (FWB) Sub-scale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study

    The FWB subscale assessed functional well-being related QoL in participants with breast cancer. FWB subscale comprised of 7 items (able to work, work fulfilled, able to enjoy life, acceptance of illness, sleeping well, enjoyed normal fun activities, contented with QoL). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). Total FWB score was calculated as the sum of the 7 items and ranged from 0 to 28, where higher score indicated better functional well-being related QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.

    Measured: Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization

  20. Change From Baseline in Breast Cancer Subscale (BCS) Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study

    The BCS subscale assessed health related QoL in participants with breast cancer. BCS subscale comprised of 9 items (short of breath, self-conscious dress, tender/swollen arms, sexually attractive, bothered by hair loss, worried about familial risk, worried about family stress, bothered by weight change, able to feel like a woman). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equated to a good QoL. Total BCS score was calculated as the sum of the 9 items and ranged from 0 to 36, where higher score indicated better QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.

    Measured: Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization

  21. Number of Participants With Severe Endocrine Symptoms: QoL Sub-study

    Participants indicated prevalence of an endocrine subscale items using a 5-point scale, where 0 (not at all), 1 (a little bit), 2 (somewhat), 3 (quite a bit), 4 (very much). Endocrine items were grouped in five categories vasomotor (hot flushes, cold sweats, night sweats, sleeping difficulties), neuropsychological (lack of energy, nervous feeling, lightheaded/dizzy, headaches, mood swings, feeling irritable), gastrointestinal symptoms (nausea, gained weight, vomiting, diarrhea, bloated feeling), gynecological symptoms (vaginal discharge, vaginal irritation, vaginal bleeding, vaginal dryness, discomfort with intercourse, lost interest in sex, breast tenderness) and other symptoms (pain, feeling ill, side effects). Number of participants who reported severe endocrine symptoms (defined as response categories "quite a bit" and "very much") were presented.

    Measured: Baseline up to 24 months after randomization

  22. Percentage of Participants With Endometrial Thickness Greater Than or Equal to (>=) 5 Millimeter (mm): Endometrial Sub-study

    Endometrial thickness was assessed using transvaginal ultrasound examination. 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.

    Measured: 6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment

  23. Endometrial Thickness: Endometrial Sub-study

    Endometrial thickness was assessed using transvaginal ultrasound examination. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.

    Measured: Baseline, 6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment

  24. Uterine and Overall Ovary Volume: Endometrial Sub-study

    Uterine volume (UV) and ovarian volume was estimated using ultrasonography. Uterine volume = (longitudinal diameter * transverse diameter * anteroposterior diameter of uterus)/(2*1000). Ovary volume = [(longitudinal diameter * transverse diameter * anteroposterior diameter of ovary) * 3.14]/(6*1000). Overall ovary volume (OV) is calculated as the sum of the right and left ovary volume. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.

    Measured: 6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment

  25. Number of Participants With Polyps, Fibroids and Ovarian Cysts: Endometrial Sub-study

    Number of participants with presence of polyps (POL) and fibroids (FIB) at post-baseline time points compared to the baseline (BL) status of 'yes', 'no' or 'missing' (that is, participants reporting POL/FIB at post-baseline time points who had yes, no or missing POL/FIB status at baseline, respectively) were presented. Result for number of participants with ovarian cysts was not analyzed at post-baseline time points as very few participants reported ovarian cysts at baseline.

    Measured: 6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment

  26. Percentage of Participants With at Least 1 Gynecological Symptoms: Endometrial Sub-study

    Gynecological symptoms included bleeding/spotting, pelvic pain, leucorrhoea and vaginal itching.

    Measured: Baseline up to 24 months post-treatment

  27. Number of Participants With Histological Findings: Endometrial Sub-study

    Measured: Baseline up to 24 months post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2002 (estimated)
  2. Study startFeb 1998
  3. Primary completionJun 2003
  4. Study completionMar 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
4,740 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00038467
Sponsor's protocol ID
96-OEXE-031
Other IDs
A5991012
Acronym
IES
Status last verified
Apr 2014
First submitted
31 May 2002
Last updated
7 May 2014
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tamoxifen and Exemestane in people with Breast Neoplasms, run by Pfizer at 377 sites in 37 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 377 sites in United States, Italy, United Kingdom, France, Netherlands and 32 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-Free Survival (DFS) at Month 36 Post-Randomization: Main Study (time frame: Baseline up to Month 36). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00038467.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2014.

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