Randomized Trial Of Exemestane Versus Continued Tamoxifen In Postmenopausal Women With Early Breast Cancer (IES)
This study has been completed.
Sponsor:
Pfizer
Collaborator:
International Collaborative Cancer Group (ICCG)
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00038467
First received: May 31, 2002
Last updated: May 9, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Neoplasms |
Drug: Tamoxifen Drug: Exemestane |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Disease Free Survival (DFS) [ Time Frame: June 2003, February 2006, December 2009, February 2013 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall survival (OS) [ Time Frame: June 2003, February 2006, December 2009, February 2013 ] [ Designated as safety issue: No ]
- Incidence of second breast cancer (in contralateral breast) [ Time Frame: June 2003, February 2006, December 2009, February 2013 ] [ Designated as safety issue: No ]
- Long term tolerability of the regimens [ Time Frame: February 2006 ] [ Designated as safety issue: Yes ]
| Enrollment: | 4738 |
| Study Start Date: | February 1998 |
| Study Completion Date: | March 2013 |
| Primary Completion Date: | June 2003 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: B |
Drug: Tamoxifen
Tamoxifen 20 mg/day tablets administered p.o. for a period ranging from 2.5 to 3 years.
|
| Experimental: A |
Drug: Exemestane
Exemestane 25 mg/day tablets administered p.o. for a period ranging from 2.5 to 3 years.
|
Eligibility| Ages Eligible for Study: | 30 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- unresectable breast cancer
- ER negative primary tumor
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00038467
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| United States, Alabama | |
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| Birmingham, Alabama, United States, 35235 | |
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| Birmingham, Alabama, United States, 35205 | |
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| Angers, France, 49033 Cedex 01 | |
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| Annecy Cedex, France, 74011 | |
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| South Africa | |
| Pfizer Investigational Site | |
| Johannesburg, Gauteng, South Africa, 2196 | |
| Pfizer Investigational Site | |
| Observatory, South Africa, 7925 | |
| Spain | |
| Pfizer Investigational Site | |
| Alcoy, Alicante, Spain, 03804 | |
| Pfizer Investigational Site | |
| Elche, Alicante, Spain, 03203 | |
| Pfizer Investigational Site | |
| San Juan de Alicante, Alicante, Spain, 03550 | |
| Pfizer Investigational Site | |
| Sant Joan D'Alacant, Alicante, Spain, 03550 | |
| Pfizer Investigational Site | |
| Badalona, Barcelona, Spain, 08911 | |
| Pfizer Investigational Site | |
| Badalona, Barcelona, Spain, 08916 | |
| Pfizer Investigational Site | |
| Terrassa, Barcelona, Spain, 08227 | |
| Pfizer Investigational Site | |
| Terrassa, Barcelona, Spain, 08221 | |
| Pfizer Investigational Site | |
| San Sebastian, Guipuzcoa, Spain, 20014 | |
| Pfizer Investigational Site | |
| Barbastro, Huesca, Spain, 22300 | |
| Pfizer Investigational Site | |
| Reus, Tarragona, Spain, 43201 | |
| Pfizer Investigational Site | |
| Albacete, Spain, 02006 | |
| Pfizer Investigational Site | |
| Alicante, Spain, 03010 | |
| Pfizer Investigational Site | |
| Badajoz, Spain, 06080 | |
| Pfizer Investigational Site | |
| Badajoz, Spain, 06008 | |
| Pfizer Investigational Site | |
| Cordoba, Spain, 14004 | |
| Pfizer Investigational Site | |
| Guadalajara, Spain, 19002 | |
| Pfizer Investigational Site | |
| Lleida, Spain, 25198 | |
| Pfizer Investigational Site | |
| Madrid, Spain, 28040 | |
| Pfizer Investigational Site | |
| Madrid, Spain, 28041 | |
| Pfizer Investigational Site | |
| Madrid, Spain, 28034 | |
| Pfizer Investigational Site | |
| Valencia, Spain, 46014 | |
| Pfizer Investigational Site | |
| Zaragoza, Spain, 50009 | |
| Sweden | |
| Pfizer Investigational Site | |
| Bor, Sweden, 50182 | |
| Pfizer Investigational Site | |
| Boras, Sweden, 501 82 | |
| Pfizer Investigational Site | |
| Goteborg, Sweden, 413 45 | |
| Pfizer Investigational Site | |
| Halmstad, Sweden, 301 85 | |
| Pfizer Investigational Site | |
| Helsingborg, Sweden, 251 87 | |
| Pfizer Investigational Site | |
| Kristianstad, Sweden, 291 85 | |
| Pfizer Investigational Site | |
| Linkoping, Sweden, 581 85 | |
| Pfizer Investigational Site | |
| Lund, Sweden, 221 85 | |
| Pfizer Investigational Site | |
| Malmo, Sweden, 205 02 | |
| Pfizer Investigational Site | |
| Motala, Sweden, 591 85 | |
| Pfizer Investigational Site | |
| Nassjo, Sweden, 575 81 | |
| Pfizer Investigational Site | |
| Norrkoping, Sweden, 601 82 | |
| Pfizer Investigational Site | |
| Varnamo, Sweden, 331 85 | |
| Pfizer Investigational Site | |
| Vasteras, Sweden, 721 89 | |
| Pfizer Investigational Site | |
| Vastervik, Sweden, 59381 | |
| Pfizer Investigational Site | |
| Vaxjo, Sweden, 351 85 | |
| Switzerland | |
| Pfizer Investigational Site | |
| Basel, Switzerland, CH-4031 | |
| Pfizer Investigational Site | |
| Bellinzona, Switzerland, CH-6500 | |
| Pfizer Investigational Site | |
| Bern, Switzerland, 3010 | |
| Pfizer Investigational Site | |
| Bern, Switzerland, CH-3012 | |
| Pfizer Investigational Site | |
| Geneva, Switzerland, CH-1211 | |
| United Kingdom | |
| Pfizer Investigational Site | |
| Huntingdon, Cambs, United Kingdom, PE18 8NT | |
| Pfizer Investigational Site | |
| Bournemouth, Dorset, United Kingdom, BH7 7DW | |
| Pfizer Investigational Site | |
| Hull, East Yorkshire, United Kingdom, HU16 5JQ | |
| Pfizer Investigational Site | |
| Epping, Essex, United Kingdom, CM166TN | |
| Pfizer Investigational Site | |
| Westcliff-On-Sea, Essex, United Kingdom, SS0 0RY | |
| Pfizer Investigational Site | |
| Newport, Gwent, United Kingdom, NP6 2UB | |
| Pfizer Investigational Site | |
| Bangor, Gwynedd, United Kingdom, LL57 2PW | |
| Pfizer Investigational Site | |
| Salterhebble, Halifax, United Kingdom, HX6 0PW | |
| Pfizer Investigational Site | |
| Gosport, Hants, United Kingdom, PO12 2AA | |
| Pfizer Investigational Site | |
| Northwood, Middlesex, United Kingdom, HA6 2RN | |
| Pfizer Investigational Site | |
| Londonderry, N. Ireland, United Kingdom, BT47 1SB | |
| Pfizer Investigational Site | |
| Harrogate, N. Yorkshire, United Kingdom, HG2 7SX | |
| Pfizer Investigational Site | |
| Taunton, Somerset, United Kingdom, TA1 5DA | |
| Pfizer Investigational Site | |
| Swansea, South Wales, United Kingdom, SA2 8QA | |
| Pfizer Investigational Site | |
| York, Yorkshire, United Kingdom, Y03 7He | |
| Pfizer Investigational Site | |
| Belfast, United Kingdom, BT97AB | |
| Pfizer Investigational Site | |
| Bradford, United Kingdom, BD9 6RJ | |
| Pfizer Investigational Site | |
| Bristol, United Kingdom, BS10 5NB | |
| Pfizer Investigational Site | |
| Cardiff, United Kingdom, CF14 2TL | |
| Pfizer Investigational Site | |
| Coventry, United Kingdom, CV2 2DX | |
| Pfizer Investigational Site | |
| East Kilbride, United Kingdom, G75 8RG | |
| Pfizer Investigational Site | |
| Huddersfield, United Kingdom, HD3 3EA | |
| Pfizer Investigational Site | |
| Leeds, United Kingdom, LS1 3EX | |
| Pfizer Investigational Site | |
| Leeds, United Kingdom, LS9 7TF | |
| Pfizer Investigational Site | |
| Lincoln, United Kingdom | |
| Pfizer Investigational Site | |
| London, United Kingdom, W6 8RF | |
| Pfizer Investigational Site | |
| London, United Kingdom, N18 1QX | |
| Pfizer Investigational Site | |
| London, United Kingdom, SW17 0QT | |
| Pfizer Investigational Site | |
| London, United Kingdom, NW3 2QG | |
| Pfizer Investigational Site | |
| London, United Kingdom, N19 5NF | |
| Pfizer Investigational Site | |
| Luton, United Kingdom, LU4 0DZ | |
| Pfizer Investigational Site | |
| Manchester, United Kingdom, M20 4BX | |
| Pfizer Investigational Site | |
| Sheffield, United Kingdom, S10 2SJ | |
| Pfizer Investigational Site | |
| Shrewsbury, United Kingdom | |
| Pfizer Investigational Site | |
| Somerset, United Kingdom, BA21 4AT | |
| Pfizer Investigational Site | |
| Southampton, United Kingdom, S016 6YD | |
| Pfizer Investigational Site | |
| Steeton, United Kingdom, BD20 6TD | |
| Pfizer Investigational Site | |
| Stoke on Trent, United Kingdom, ST4 6QG | |
| Pfizer Investigational Site | |
| Telford, United Kingdom, TF1 6TF | |
| Pfizer Investigational Site | |
| Wythenshawe, Manchester, United Kingdom, M23 9LT | |
Sponsors and Collaborators
Pfizer
International Collaborative Cancer Group (ICCG)
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00038467 History of Changes |
| Other Study ID Numbers: | 96-OEXE-031, A5991012 |
| Study First Received: | May 31, 2002 |
| Last Updated: | May 9, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms Neoplasms by Site Breast Diseases Skin Diseases Tamoxifen Exemestane Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Bone Density Conservation Agents Estrogen Antagonists Aromatase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013