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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00038467




Registration number
NCT00038467
Ethics application status
Date submitted
31/05/2002
Date registered
3/06/2002
Date last updated
7/05/2014

Titles & IDs
Public title
Randomized Trial Of Exemestane Versus Continued Tamoxifen In Postmenopausal Women With Early Breast Cancer
Scientific 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
Secondary ID [1] 0 0
A5991012
Secondary ID [2] 0 0
96-OEXE-031
Universal Trial Number (UTN)
Trial acronym
IES
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tamoxifen
Treatment: Drugs - Exemestane

Active comparator: B -

Experimental: A -


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

Treatment: Drugs: Exemestane
Exemestane 25 mg/day tablets administered p.o. for a period ranging from 2.5 to 3 years.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Disease-Free Survival (DFS) at Month 36 Post-Randomization: Main Study
Timepoint [1] 0 0
Baseline up to Month 36
Secondary outcome [1] 0 0
Overall Survival (OS) at Month 36 Post-Randomization: Main Study
Timepoint [1] 0 0
Baseline up to Month 120
Secondary outcome [2] 0 0
Number of Events of Second Breast Cancer in Contralateral Breast: Main Study
Timepoint [2] 0 0
Baseline up to Month 120
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment
Secondary outcome [6] 0 0
Percentage of Bone Specific Alkaline Phosphatase (BAP) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study
Timepoint [6] 0 0
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
Secondary outcome [7] 0 0
Percentage of C-Terminal Telopeptide (CTX) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study
Timepoint [7] 0 0
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
Secondary outcome [8] 0 0
Percentage of Osteocalcin (OC) and Procollagen T1 C-Peptide (PICP) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study
Timepoint [8] 0 0
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
Secondary outcome [9] 0 0
Percentage of Deoxy-pyridinoline (DPD) Urine Concentration Relative to Baseline: Bone Metabolism Sub-study
Timepoint [9] 0 0
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
Secondary outcome [10] 0 0
Percentage of N-telopeptide of Type 1 Collagen (NTX) Urine Concentration Relative to Baseline: Bone Metabolism Sub-study
Timepoint [10] 0 0
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
Secondary outcome [11] 0 0
Number of Participants With Fracture: Bone Metabolism Sub-study
Timepoint [11] 0 0
Baseline up to 24 months post-treatment
Secondary outcome [12] 0 0
Change From Baseline in Treatment Outcome Index (TOI) at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study
Timepoint [12] 0 0
Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization
Secondary outcome [13] 0 0
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
Timepoint [13] 0 0
Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization
Secondary outcome [14] 0 0
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
Timepoint [14] 0 0
Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization
Secondary outcome [15] 0 0
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
Timepoint [15] 0 0
Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization
Secondary outcome [16] 0 0
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
Timepoint [16] 0 0
Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization
Secondary outcome [17] 0 0
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
Timepoint [17] 0 0
Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization
Secondary outcome [18] 0 0
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
Timepoint [18] 0 0
Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization
Secondary outcome [19] 0 0
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
Timepoint [19] 0 0
Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization
Secondary outcome [20] 0 0
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
Timepoint [20] 0 0
Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization
Secondary outcome [21] 0 0
Number of Participants With Severe Endocrine Symptoms: QoL Sub-study
Timepoint [21] 0 0
Baseline up to 24 months after randomization
Secondary outcome [22] 0 0
Percentage of Participants With Endometrial Thickness Greater Than or Equal to (>=) 5 Millimeter (mm): Endometrial Sub-study
Timepoint [22] 0 0
6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment
Secondary outcome [23] 0 0
Endometrial Thickness: Endometrial Sub-study
Timepoint [23] 0 0
Baseline, 6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment
Secondary outcome [24] 0 0
Uterine and Overall Ovary Volume: Endometrial Sub-study
Timepoint [24] 0 0
6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment
Secondary outcome [25] 0 0
Number of Participants With Polyps, Fibroids and Ovarian Cysts: Endometrial Sub-study
Timepoint [25] 0 0
6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment
Secondary outcome [26] 0 0
Percentage of Participants With at Least 1 Gynecological Symptoms: Endometrial Sub-study
Timepoint [26] 0 0
Baseline up to 24 months post-treatment
Secondary outcome [27] 0 0
Number of Participants With Histological Findings: Endometrial Sub-study
Timepoint [27] 0 0
Baseline up to 24 months post-treatment

Eligibility
Key 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
Minimum age
30 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* unresectable breast cancer
* ER negative primary tumor

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/1998
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2013
Sample size
Target
Accrual to date
Final
4740
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Camperdown
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Dubbo
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Liverpool
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Waratah
Recruitment hospital [5] 0 0
Pfizer Investigational Site - Adelaide
Recruitment hospital [6] 0 0
Pfizer Investigational Site - Bendigo
Recruitment hospital [7] 0 0
Pfizer Investigational Site - Box Hill
Recruitment hospital [8] 0 0
Pfizer Investigational Site - Ringwood East
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2830 - Dubbo
Recruitment postcode(s) [3] 0 0
2170 - Liverpool
Recruitment postcode(s) [4] 0 0
2298 - Waratah
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
Recruitment postcode(s) [6] 0 0
3552 - Bendigo
Recruitment postcode(s) [7] 0 0
3128 - Box Hill
Recruitment postcode(s) [8] 0 0
3135 - Ringwood East
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Oregon
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Washington
Country [12] 0 0
Argentina
State/province [12] 0 0
Buenos Aires
Country [13] 0 0
Argentina
State/province [13] 0 0
Capital Federal
Country [14] 0 0
Argentina
State/province [14] 0 0
Pcia. de Santa Fe
Country [15] 0 0
Argentina
State/province [15] 0 0
Santa Fe
Country [16] 0 0
Argentina
State/province [16] 0 0
Cordoba
Country [17] 0 0
Belgium
State/province [17] 0 0
Antwerpen
Country [18] 0 0
Belgium
State/province [18] 0 0
Arlon
Country [19] 0 0
Belgium
State/province [19] 0 0
Baudour
Country [20] 0 0
Belgium
State/province [20] 0 0
Brasschaat
Country [21] 0 0
Belgium
State/province [21] 0 0
Bruxelles
Country [22] 0 0
Belgium
State/province [22] 0 0
Charleroi
Country [23] 0 0
Belgium
State/province [23] 0 0
Edegem
Country [24] 0 0
Belgium
State/province [24] 0 0
Genk
Country [25] 0 0
Belgium
State/province [25] 0 0
Haine St. Paul
Country [26] 0 0
Belgium
State/province [26] 0 0
Hasselt
Country [27] 0 0
Belgium
State/province [27] 0 0
Kraainem
Country [28] 0 0
Belgium
State/province [28] 0 0
La Louviere
Country [29] 0 0
Belgium
State/province [29] 0 0
Leuven
Country [30] 0 0
Belgium
State/province [30] 0 0
Liege
Country [31] 0 0
Belgium
State/province [31] 0 0
Merksem
Country [32] 0 0
Belgium
State/province [32] 0 0
Namur
Country [33] 0 0
Belgium
State/province [33] 0 0
Verviers
Country [34] 0 0
Belgium
State/province [34] 0 0
Wilrijk
Country [35] 0 0
Bosnia and Herzegovina
State/province [35] 0 0
Sarajevo
Country [36] 0 0
Bulgaria
State/province [36] 0 0
Plovdiv
Country [37] 0 0
Bulgaria
State/province [37] 0 0
Sofia
Country [38] 0 0
Bulgaria
State/province [38] 0 0
Stara Zagora
Country [39] 0 0
Croatia
State/province [39] 0 0
Osijek
Country [40] 0 0
Croatia
State/province [40] 0 0
Split
Country [41] 0 0
Croatia
State/province [41] 0 0
Zagreb
Country [42] 0 0
Czech Republic
State/province [42] 0 0
Brno
Country [43] 0 0
Czech Republic
State/province [43] 0 0
Ceske Budejovice
Country [44] 0 0
Czech Republic
State/province [44] 0 0
Prague 2
Country [45] 0 0
Denmark
State/province [45] 0 0
Aarhus C
Country [46] 0 0
Denmark
State/province [46] 0 0
Esbjerg
Country [47] 0 0
Denmark
State/province [47] 0 0
Herlev
Country [48] 0 0
Denmark
State/province [48] 0 0
Herning
Country [49] 0 0
Denmark
State/province [49] 0 0
Hilleroed
Country [50] 0 0
Denmark
State/province [50] 0 0
Koebenhavn OE
Country [51] 0 0
Denmark
State/province [51] 0 0
Naestved
Country [52] 0 0
Denmark
State/province [52] 0 0
Roskilde
Country [53] 0 0
Denmark
State/province [53] 0 0
Vejle
Country [54] 0 0
Denmark
State/province [54] 0 0
Viborg
Country [55] 0 0
Egypt
State/province [55] 0 0
Cairo
Country [56] 0 0
Estonia
State/province [56] 0 0
Tartu
Country [57] 0 0
France
State/province [57] 0 0
Angers
Country [58] 0 0
France
State/province [58] 0 0
Annecy Cedex
Country [59] 0 0
France
State/province [59] 0 0
Avignon Cedex 2
Country [60] 0 0
France
State/province [60] 0 0
Bordeaux
Country [61] 0 0
France
State/province [61] 0 0
Brest
Country [62] 0 0
France
State/province [62] 0 0
Caen Cedex 05
Country [63] 0 0
France
State/province [63] 0 0
Caen
Country [64] 0 0
France
State/province [64] 0 0
Clermont Ferrand
Country [65] 0 0
France
State/province [65] 0 0
Evreux
Country [66] 0 0
France
State/province [66] 0 0
Lagny Sur Marne
Country [67] 0 0
France
State/province [67] 0 0
Le Havre
Country [68] 0 0
France
State/province [68] 0 0
Le Mans
Country [69] 0 0
France
State/province [69] 0 0
Lille
Country [70] 0 0
France
State/province [70] 0 0
Lyon
Country [71] 0 0
France
State/province [71] 0 0
Marseille
Country [72] 0 0
France
State/province [72] 0 0
Meaux
Country [73] 0 0
France
State/province [73] 0 0
Montbeliard
Country [74] 0 0
France
State/province [74] 0 0
Mulhouse
Country [75] 0 0
France
State/province [75] 0 0
Nice
Country [76] 0 0
France
State/province [76] 0 0
Paris
Country [77] 0 0
France
State/province [77] 0 0
Perpignan
Country [78] 0 0
France
State/province [78] 0 0
Rennes
Country [79] 0 0
France
State/province [79] 0 0
Rouen
Country [80] 0 0
France
State/province [80] 0 0
Saint-Herblain
Country [81] 0 0
France
State/province [81] 0 0
St Cloud
Country [82] 0 0
France
State/province [82] 0 0
Strasbourg
Country [83] 0 0
France
State/province [83] 0 0
Toulouse
Country [84] 0 0
Germany
State/province [84] 0 0
Berlin
Country [85] 0 0
Germany
State/province [85] 0 0
Chemnitz
Country [86] 0 0
Germany
State/province [86] 0 0
Erlangen
Country [87] 0 0
Germany
State/province [87] 0 0
Freiburg
Country [88] 0 0
Germany
State/province [88] 0 0
Gera
Country [89] 0 0
Germany
State/province [89] 0 0
Greiz
Country [90] 0 0
Germany
State/province [90] 0 0
Halle
Country [91] 0 0
Germany
State/province [91] 0 0
Hamburg
Country [92] 0 0
Germany
State/province [92] 0 0
Hildburghausen
Country [93] 0 0
Germany
State/province [93] 0 0
Leipzig
Country [94] 0 0
Germany
State/province [94] 0 0
Luebeck
Country [95] 0 0
Germany
State/province [95] 0 0
Muenchen
Country [96] 0 0
Germany
State/province [96] 0 0
Riesa
Country [97] 0 0
Germany
State/province [97] 0 0
Rodewisch
Country [98] 0 0
Germany
State/province [98] 0 0
Saarbruecken
Country [99] 0 0
Germany
State/province [99] 0 0
Suhl
Country [100] 0 0
Germany
State/province [100] 0 0
Weiden
Country [101] 0 0
Greece
State/province [101] 0 0
Attiki
Country [102] 0 0
Greece
State/province [102] 0 0
Crete
Country [103] 0 0
Hong Kong
State/province [103] 0 0
New Territories
Country [104] 0 0
Hungary
State/province [104] 0 0
Budapest
Country [105] 0 0
Ireland
State/province [105] 0 0
Cork, Ireland
Country [106] 0 0
Ireland
State/province [106] 0 0
Cork
Country [107] 0 0
Ireland
State/province [107] 0 0
Dublin 9
Country [108] 0 0
Ireland
State/province [108] 0 0
Dublin
Country [109] 0 0
Ireland
State/province [109] 0 0
Galway
Country [110] 0 0
Israel
State/province [110] 0 0
Haifa
Country [111] 0 0
Israel
State/province [111] 0 0
Jerusalem
Country [112] 0 0
Israel
State/province [112] 0 0
Kfar Saba
Country [113] 0 0
Israel
State/province [113] 0 0
Petah Tikva
Country [114] 0 0
Israel
State/province [114] 0 0
Rehovot
Country [115] 0 0
Italy
State/province [115] 0 0
Modena
Country [116] 0 0
Italy
State/province [116] 0 0
Alba (CN)
Country [117] 0 0
Italy
State/province [117] 0 0
Aviano (PN)
Country [118] 0 0
Italy
State/province [118] 0 0
Bergamo
Country [119] 0 0
Italy
State/province [119] 0 0
Biella
Country [120] 0 0
Italy
State/province [120] 0 0
Cagliari
Country [121] 0 0
Italy
State/province [121] 0 0
Casale Monferrato, AL
Country [122] 0 0
Italy
State/province [122] 0 0
Correggio
Country [123] 0 0
Italy
State/province [123] 0 0
Cremona
Country [124] 0 0
Italy
State/province [124] 0 0
Cuneo
Country [125] 0 0
Italy
State/province [125] 0 0
Fermo FM
Country [126] 0 0
Italy
State/province [126] 0 0
Firenze
Country [127] 0 0
Italy
State/province [127] 0 0
Genova
Country [128] 0 0
Italy
State/province [128] 0 0
Lecco
Country [129] 0 0
Italy
State/province [129] 0 0
Lodi
Country [130] 0 0
Italy
State/province [130] 0 0
Mantova
Country [131] 0 0
Italy
State/province [131] 0 0
Milano
Country [132] 0 0
Italy
State/province [132] 0 0
Monserrato (CA)
Country [133] 0 0
Italy
State/province [133] 0 0
Monza
Country [134] 0 0
Italy
State/province [134] 0 0
Napoli
Country [135] 0 0
Italy
State/province [135] 0 0
Palermo
Country [136] 0 0
Italy
State/province [136] 0 0
Parma
Country [137] 0 0
Italy
State/province [137] 0 0
Perugia
Country [138] 0 0
Italy
State/province [138] 0 0
Piacenza
Country [139] 0 0
Italy
State/province [139] 0 0
Pietra Ligure (SV)
Country [140] 0 0
Italy
State/province [140] 0 0
Pisa
Country [141] 0 0
Italy
State/province [141] 0 0
Reggio Emilia
Country [142] 0 0
Italy
State/province [142] 0 0
Roma
Country [143] 0 0
Italy
State/province [143] 0 0
Sassari
Country [144] 0 0
Italy
State/province [144] 0 0
Terni
Country [145] 0 0
Italy
State/province [145] 0 0
Thiene (VI)
Country [146] 0 0
Italy
State/province [146] 0 0
Torino
Country [147] 0 0
Italy
State/province [147] 0 0
Tortona
Country [148] 0 0
Italy
State/province [148] 0 0
Trescore Balneario BG
Country [149] 0 0
Italy
State/province [149] 0 0
Treviglio (BG)
Country [150] 0 0
Italy
State/province [150] 0 0
Varese
Country [151] 0 0
Luxembourg
State/province [151] 0 0
Luxembourg
Country [152] 0 0
Malta
State/province [152] 0 0
Floriana
Country [153] 0 0
Netherlands
State/province [153] 0 0
Amersfoort
Country [154] 0 0
Netherlands
State/province [154] 0 0
Amsterdam
Country [155] 0 0
Netherlands
State/province [155] 0 0
Apeldoorn
Country [156] 0 0
Netherlands
State/province [156] 0 0
Blaricum
Country [157] 0 0
Netherlands
State/province [157] 0 0
Breda
Country [158] 0 0
Netherlands
State/province [158] 0 0
Delft
Country [159] 0 0
Netherlands
State/province [159] 0 0
Den Haag
Country [160] 0 0
Netherlands
State/province [160] 0 0
Eindhoven
Country [161] 0 0
Netherlands
State/province [161] 0 0
Enschede
Country [162] 0 0
Netherlands
State/province [162] 0 0
Groningen
Country [163] 0 0
Netherlands
State/province [163] 0 0
Hengelo
Country [164] 0 0
Netherlands
State/province [164] 0 0
Leeuwarden
Country [165] 0 0
Netherlands
State/province [165] 0 0
Leiden
Country [166] 0 0
Netherlands
State/province [166] 0 0
Leidschendam
Country [167] 0 0
Netherlands
State/province [167] 0 0
Podybus 90153
Country [168] 0 0
Netherlands
State/province [168] 0 0
Roermond
Country [169] 0 0
Netherlands
State/province [169] 0 0
Sittard
Country [170] 0 0
Netherlands
State/province [170] 0 0
Utrecht
Country [171] 0 0
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Wythenshawe, Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
International Collaborative Cancer Group
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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 cancer and long-term tolerability.
Trial website
https://clinicaltrials.gov/study/NCT00038467
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00038467