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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00038467
Other study ID # 96-OEXE-031
Secondary ID A5991012
Status Completed
Phase Phase 3
First received May 31, 2002
Last updated April 21, 2014
Start date February 1998
Est. completion date March 2013

Study information

Verified date April 2014
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical 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 cancer and long-term tolerability.


Recruitment information / eligibility

Status Completed
Enrollment 4740
Est. completion date March 2013
Est. primary completion date June 2003
Accepts healthy volunteers No
Gender Female
Age group 30 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Tamoxifen
Tamoxifen 20 mg/day tablets administered p.o. for a period ranging from 2.5 to 3 years.
Exemestane
Exemestane 25 mg/day tablets administered p.o. for a period ranging from 2.5 to 3 years.

Locations

Country Name City State
Argentina Pfizer Investigational Site Buenos Aires Capital Federal
Argentina Pfizer Investigational Site Buenos Aires Capital Federal
Argentina Pfizer Investigational Site Buenos Aires Capital Federal
Argentina Pfizer Investigational Site Buenos Aires Capital Federal
Argentina Pfizer Investigational Site Buenos Aires Capital Federal
Argentina Pfizer Investigational Site Buenos Aires
Argentina Pfizer Investigational Site Cordoba
Argentina Pfizer Investigational Site Haedo Buenos Aires
Argentina Pfizer Investigational Site Rosario Santa Fe
Argentina Pfizer Investigational Site Rosario 2000 Pcia. de Santa Fe
Argentina Pfizer Investigational Site San Isidro Buenos Aires
Argentina Pfizer Investigational Site San Martin Buenos Aires
Australia Pfizer Investigational Site Adelaide South Australia
Australia Pfizer Investigational Site Bendigo Victoria
Australia Pfizer Investigational Site Box Hill Victoria
Australia Pfizer Investigational Site Camperdown New South Wales
Australia Pfizer Investigational Site Dubbo New South Wales
Australia Pfizer Investigational Site Liverpool New South Wales
Australia Pfizer Investigational Site Ringwood East Victoria
Australia Pfizer Investigational Site Waratah New South Wales
Belgium Pfizer Investigational Site Antwerpen
Belgium Pfizer Investigational Site Arlon
Belgium Pfizer Investigational Site Baudour
Belgium Pfizer Investigational Site Brasschaat
Belgium Pfizer Investigational Site Bruxelles
Belgium Pfizer Investigational Site Bruxelles
Belgium Pfizer Investigational Site Charleroi
Belgium Pfizer Investigational Site Edegem
Belgium Pfizer Investigational Site Genk
Belgium Pfizer Investigational Site Haine St. Paul
Belgium Pfizer Investigational Site Hasselt
Belgium Pfizer Investigational Site Kraainem
Belgium Pfizer Investigational Site La Louviere
Belgium Pfizer Investigational Site Leuven
Belgium Pfizer Investigational Site Liege
Belgium Pfizer Investigational Site Merksem
Belgium Pfizer Investigational Site Namur
Belgium Pfizer Investigational Site Verviers
Belgium Pfizer Investigational Site Wilrijk
Bosnia and Herzegovina Pfizer Investigational Site Sarajevo
Bulgaria Pfizer Investigational Site Plovdiv
Bulgaria Pfizer Investigational Site Sofia
Bulgaria Pfizer Investigational Site Sofia
Bulgaria Pfizer Investigational Site Sofia
Bulgaria Pfizer Investigational Site Stara Zagora
Croatia Pfizer Investigational Site Osijek
Croatia Pfizer Investigational Site Split
Croatia Pfizer Investigational Site Zagreb
Croatia Pfizer Investigational Site Zagreb
Czech Republic Pfizer Investigational Site Brno
Czech Republic Pfizer Investigational Site Ceske Budejovice
Czech Republic Pfizer Investigational Site Prague 2
Denmark Pfizer Investigational Site Aarhus C
Denmark Pfizer Investigational Site Esbjerg
Denmark Pfizer Investigational Site Herlev
Denmark Pfizer Investigational Site Herning
Denmark Pfizer Investigational Site Hilleroed
Denmark Pfizer Investigational Site Koebenhavn OE
Denmark Pfizer Investigational Site Naestved
Denmark Pfizer Investigational Site Roskilde
Denmark Pfizer Investigational Site Vejle
Denmark Pfizer Investigational Site Viborg
Egypt Pfizer Investigational Site Cairo
Estonia Pfizer Investigational Site Tartu
France Pfizer Investigational Site Angers
France Pfizer Investigational Site Annecy Cedex
France Pfizer Investigational Site Avignon Cedex 2
France Pfizer Investigational Site Bordeaux
France Pfizer Investigational Site Bordeaux
France Pfizer Investigational Site Brest
France Pfizer Investigational Site Caen
France Pfizer Investigational Site Caen Cedex 05
France Pfizer Investigational Site Clermont Ferrand
France Pfizer Investigational Site Evreux
France Pfizer Investigational Site Lagny Sur Marne
France Pfizer Investigational Site Le Havre
France Pfizer Investigational Site Le Mans
France Pfizer Investigational Site Lille
France Pfizer Investigational Site Lyon
France Pfizer Investigational Site Marseille
France Pfizer Investigational Site Meaux
France Pfizer Investigational Site Montbeliard
France Pfizer Investigational Site Mulhouse
France Pfizer Investigational Site Nice
France Pfizer Investigational Site Paris
France Pfizer Investigational Site Paris
France Pfizer Investigational Site Perpignan
France Pfizer Investigational Site Rennes
France Pfizer Investigational Site Rouen
France Pfizer Investigational Site Saint-Herblain
France Pfizer Investigational Site St Cloud
France Pfizer Investigational Site Strasbourg
France Pfizer Investigational Site Toulouse
Germany Pfizer Investigational Site Berlin
Germany Pfizer Investigational Site Berlin
Germany Pfizer Investigational Site Chemnitz
Germany Pfizer Investigational Site Erlangen
Germany Pfizer Investigational Site Freiburg
Germany Pfizer Investigational Site Gera
Germany Pfizer Investigational Site Greiz
Germany Pfizer Investigational Site Halle
Germany Pfizer Investigational Site Halle
Germany Pfizer Investigational Site Hamburg
Germany Pfizer Investigational Site Hildburghausen
Germany Pfizer Investigational Site Leipzig
Germany Pfizer Investigational Site Luebeck
Germany Pfizer Investigational Site Muenchen
Germany Pfizer Investigational Site Riesa
Germany Pfizer Investigational Site Rodewisch
Germany Pfizer Investigational Site Saarbruecken
Germany Pfizer Investigational Site Suhl
Germany Pfizer Investigational Site Weiden
Greece Pfizer Investigational Site Athens Attiki
Greece Pfizer Investigational Site Athens Attiki
Greece Pfizer Investigational Site Heraklion Crete
Hong Kong Pfizer Investigational Site New Territories
Hungary Pfizer Investigational Site Budapest
Hungary Pfizer Investigational Site Budapest
Hungary Pfizer Investigational Site Budapest
Ireland Pfizer Investigational Site Cork
Ireland Pfizer Investigational Site Cork, Ireland
Ireland Pfizer Investigational Site Dublin
Ireland Pfizer Investigational Site Dublin 9
Ireland Pfizer Investigational Site Galway
Israel Pfizer Investigational Site Haifa
Israel Pfizer Investigational Site Haifa
Israel Pfizer Investigational Site Jerusalem
Israel Pfizer Investigational Site Jerusalem
Israel Pfizer Investigational Site Kfar Saba
Israel Pfizer Investigational Site Petah Tikva
Israel Pfizer Investigational Site Rehovot
Italy Pfizer Investigational Site Alba (CN)
Italy Pfizer Investigational Site Aviano (PN)
Italy Pfizer Investigational Site Bergamo
Italy Pfizer Investigational Site Biella
Italy Pfizer Investigational Site Cagliari
Italy Pfizer Investigational Site Carpi Modena
Italy Pfizer Investigational Site Casale Monferrato, AL
Italy Pfizer Investigational Site Correggio
Italy Pfizer Investigational Site Cremona
Italy Pfizer Investigational Site Cuneo
Italy Pfizer Investigational Site Fermo FM
Italy Pfizer Investigational Site Firenze
Italy Pfizer Investigational Site Genova
Italy Pfizer Investigational Site Genova
Italy Pfizer Investigational Site Lecco
Italy Pfizer Investigational Site Lodi
Italy Pfizer Investigational Site Mantova
Italy Pfizer Investigational Site Milano
Italy Pfizer Investigational Site Milano
Italy Pfizer Investigational Site Milano
Italy Pfizer Investigational Site Milano
Italy Pfizer Investigational Site Modena
Italy Pfizer Investigational Site Monserrato (CA)
Italy Pfizer Investigational Site Monza
Italy Pfizer Investigational Site Napoli
Italy Pfizer Investigational Site Palermo
Italy Pfizer Investigational Site Parma
Italy Pfizer Investigational Site Perugia
Italy Pfizer Investigational Site Piacenza
Italy Pfizer Investigational Site Pietra Ligure (SV)
Italy Pfizer Investigational Site Pisa
Italy Pfizer Investigational Site Reggio Emilia
Italy Pfizer Investigational Site Roma
Italy Pfizer Investigational Site Sassari
Italy Pfizer Investigational Site Terni
Italy Pfizer Investigational Site Thiene (VI)
Italy Pfizer Investigational Site Torino
Italy Pfizer Investigational Site Tortona
Italy Pfizer Investigational Site Trescore Balneario BG
Italy Pfizer Investigational Site Treviglio (BG)
Italy Pfizer Investigational Site Varese
Luxembourg Pfizer Investigational Site Luxembourg
Malta Pfizer Investigational Site Floriana
Netherlands Pfizer Investigational Site Amersfoort
Netherlands Pfizer Investigational Site Amsterdam
Netherlands Pfizer Investigational Site Amsterdam
Netherlands Pfizer Investigational Site Amsterdam
Netherlands Pfizer Investigational Site Apeldoorn
Netherlands Pfizer Investigational Site Blaricum
Netherlands Pfizer Investigational Site Breda
Netherlands Pfizer Investigational Site Delft
Netherlands Pfizer Investigational Site Den Haag
Netherlands Pfizer Investigational Site Eindhoven
Netherlands Pfizer Investigational Site Enschede
Netherlands Pfizer Investigational Site Groningen
Netherlands Pfizer Investigational Site Groningen
Netherlands Pfizer Investigational Site Hengelo
Netherlands Pfizer Investigational Site Leeuwarden
Netherlands Pfizer Investigational Site Leiden
Netherlands Pfizer Investigational Site Leidschendam
Netherlands Pfizer Investigational Site Podybus 90153
Netherlands Pfizer Investigational Site Roermond
Netherlands Pfizer Investigational Site Sittard
Netherlands Pfizer Investigational Site Utrecht
Netherlands Pfizer Investigational Site Veldhoven
Netherlands Pfizer Investigational Site Zaandam
New Zealand Pfizer Investigational Site Auckland
New Zealand Pfizer Investigational Site Hamilton Waikato
Norway Pfizer Investigational Site Bergen
Norway Pfizer Investigational Site Bodo
Norway Pfizer Investigational Site Fredrikstad
Norway Pfizer Investigational Site Haugesund
Norway Pfizer Investigational Site Levanger
Norway Pfizer Investigational Site Mo i Rana
Norway Pfizer Investigational Site Molde
Norway Pfizer Investigational Site Notodden
Norway Pfizer Investigational Site Oslo
Norway Pfizer Investigational Site Rissa
Norway Pfizer Investigational Site Rjukan
Norway Pfizer Investigational Site Sandefjord
Norway Pfizer Investigational Site Tonsberg
Norway Pfizer Investigational Site Tromso
Norway Pfizer Investigational Site Tromsø
Peru Pfizer Investigational Site Lima
Poland Pfizer Investigational Site Gdansk
Poland Pfizer Investigational Site Gliwice
Poland Pfizer Investigational Site Krakow
Poland Pfizer Investigational Site Krakow
Poland Pfizer Investigational Site Lodz
Poland Pfizer Investigational Site Opole
Poland Pfizer Investigational Site Poznan
Poland Pfizer Investigational Site Sopot
Poland Pfizer Investigational Site Warszawa
Portugal Pfizer Investigational Site Coimbra
Portugal Pfizer Investigational Site Coimbra
Portugal Pfizer Investigational Site Evora
Romania Pfizer Investigational Site Bucuresti
Romania Pfizer Investigational Site Cluj Napoca
Romania Pfizer Investigational Site Timisoara
Russian Federation Pfizer Investigational Site St. Petersburg
Serbia Pfizer Investigational Site Belgrade
Serbia Pfizer Investigational Site Sremska Kamenica
Slovakia Pfizer Investigational Site Banska Bystrica
Slovakia Pfizer Investigational Site Bratislava
Slovakia Pfizer Investigational Site Kosice
Slovenia Pfizer Investigational Site Ljubljana
South Africa Pfizer Investigational Site Johannesburg Gauteng
South Africa Pfizer Investigational Site Observatory
Spain Pfizer Investigational Site Albacete
Spain Pfizer Investigational Site Alcoy Alicante
Spain Pfizer Investigational Site Alicante
Spain Pfizer Investigational Site Badajoz
Spain Pfizer Investigational Site Badajoz
Spain Pfizer Investigational Site Badalona Barcelona
Spain Pfizer Investigational Site Badalona Barcelona
Spain Pfizer Investigational Site Barbastro Huesca
Spain Pfizer Investigational Site Cordoba
Spain Pfizer Investigational Site Elche Alicante
Spain Pfizer Investigational Site Guadalajara
Spain Pfizer Investigational Site Lleida
Spain Pfizer Investigational Site Madrid
Spain Pfizer Investigational Site Madrid
Spain Pfizer Investigational Site Madrid
Spain Pfizer Investigational Site Reus Tarragona
Spain Pfizer Investigational Site San Juan de Alicante Alicante
Spain Pfizer Investigational Site San Sebastian Guipuzcoa
Spain Pfizer Investigational Site Sant Joan D'Alacant Alicante
Spain Pfizer Investigational Site Terrassa Barcelona
Spain Pfizer Investigational Site Terrassa Barcelona
Spain Pfizer Investigational Site Valencia
Spain Pfizer Investigational Site Zaragoza
Sweden Pfizer Investigational Site Boras
Sweden Pfizer Investigational Site Borås
Sweden Pfizer Investigational Site Goteborg
Sweden Pfizer Investigational Site Halmstad
Sweden Pfizer Investigational Site Helsingborg
Sweden Pfizer Investigational Site Kristianstad
Sweden Pfizer Investigational Site Linkoping
Sweden Pfizer Investigational Site Lund
Sweden Pfizer Investigational Site Malmo
Sweden Pfizer Investigational Site Motala
Sweden Pfizer Investigational Site Nässjö
Sweden Pfizer Investigational Site Norrkoping
Sweden Pfizer Investigational Site Varnamo
Sweden Pfizer Investigational Site Vasteras
Sweden Pfizer Investigational Site Vastervik
Sweden Pfizer Investigational Site Vaxjo
Switzerland Pfizer Investigational Site Basel
Switzerland Pfizer Investigational Site Bellinzona
Switzerland Pfizer Investigational Site Bern
Switzerland Pfizer Investigational Site Bern
Switzerland Pfizer Investigational Site Genève
United Kingdom Pfizer Investigational Site Bangor Gwynedd
United Kingdom Pfizer Investigational Site Belfast
United Kingdom Pfizer Investigational Site Bournemouth Dorset
United Kingdom Pfizer Investigational Site Bradford
United Kingdom Pfizer Investigational Site Bristol
United Kingdom Pfizer Investigational Site Cardiff
United Kingdom Pfizer Investigational Site Coventry
United Kingdom Pfizer Investigational Site East Kilbride
United Kingdom Pfizer Investigational Site Epping Essex
United Kingdom Pfizer Investigational Site Gosport Hants
United Kingdom Pfizer Investigational Site Harrogate N. Yorkshire
United Kingdom Pfizer Investigational Site Huddersfield
United Kingdom Pfizer Investigational Site Hull East Yorkshire
United Kingdom Pfizer Investigational Site Huntingdon Cambs
United Kingdom Pfizer Investigational Site Leeds
United Kingdom Pfizer Investigational Site Leeds
United Kingdom Pfizer Investigational Site Lincoln
United Kingdom Pfizer Investigational Site London
United Kingdom Pfizer Investigational Site London
United Kingdom Pfizer Investigational Site London
United Kingdom Pfizer Investigational Site London
United Kingdom Pfizer Investigational Site London
United Kingdom Pfizer Investigational Site Londonderry N. Ireland
United Kingdom Pfizer Investigational Site Luton
United Kingdom Pfizer Investigational Site Manchester
United Kingdom Pfizer Investigational Site Newport Gwent
United Kingdom Pfizer Investigational Site Northwood Middlesex
United Kingdom Pfizer Investigational Site Salterhebble Halifax
United Kingdom Pfizer Investigational Site Sheffield
United Kingdom Pfizer Investigational Site Shrewsbury
United Kingdom Pfizer Investigational Site Somerset
United Kingdom Pfizer Investigational Site Southampton
United Kingdom Pfizer Investigational Site Steeton
United Kingdom Pfizer Investigational Site Stoke on Trent
United Kingdom Pfizer Investigational Site Swansea South Wales
United Kingdom Pfizer Investigational Site Taunton Somerset
United Kingdom Pfizer Investigational Site Telford
United Kingdom Pfizer Investigational Site Westcliff-On-Sea Essex
United Kingdom Pfizer Investigational Site Wythenshawe, Manchester
United Kingdom Pfizer Investigational Site York Yorkshire
United States Pfizer Investigational Site Albany New York
United States Pfizer Investigational Site Arlington Texas
United States Pfizer Investigational Site Bedford Texas
United States Pfizer Investigational Site Birmingham Alabama
United States Pfizer Investigational Site Birmingham Alabama
United States Pfizer Investigational Site Birmingham Alabama
United States Pfizer Investigational Site Boulder Colorado
United States Pfizer Investigational Site Cedar Rapids Iowa
United States Pfizer Investigational Site Colorado Springs Colorado
United States Pfizer Investigational Site Dallas Texas
United States Pfizer Investigational Site Dallas Texas
United States Pfizer Investigational Site Dallas Texas
United States Pfizer Investigational Site Denver Colorado
United States Pfizer Investigational Site El Paso Texas
United States Pfizer Investigational Site El Paso Texas
United States Pfizer Investigational Site Fishers Indiana
United States Pfizer Investigational Site Fishers Indiana
United States Pfizer Investigational Site Fort Collins Colorado
United States Pfizer Investigational Site Garland Texas
United States Pfizer Investigational Site Green Valley Arizona
United States Pfizer Investigational Site Green Velley Arizona
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site Indianapolis Indiana
United States Pfizer Investigational Site Indianapolis Indiana
United States Pfizer Investigational Site Indianapolis Indiana
United States Pfizer Investigational Site Jacksonville Florida
United States Pfizer Investigational Site Jacksonville Florida
United States Pfizer Investigational Site Jacksonville Beach Florida
United States Pfizer Investigational Site Lakewood Colorado
United States Pfizer Investigational Site Latham New York
United States Pfizer Investigational Site Longview Texas
United States Pfizer Investigational Site McAllen Texas
United States Pfizer Investigational Site Mesquite Texas
United States Pfizer Investigational Site Ocala Florida
United States Pfizer Investigational Site Odessa Texas
United States Pfizer Investigational Site Orange Park Florida
United States Pfizer Investigational Site Pasadena Texas
United States Pfizer Investigational Site Pittsfield Massachusetts
United States Pfizer Investigational Site Plano Texas
United States Pfizer Investigational Site Portland Oregon
United States Pfizer Investigational Site Portland Oregon
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site Sherman Texas
United States Pfizer Investigational Site Spokane Washington
United States Pfizer Investigational Site Spokane Washington
United States Pfizer Investigational Site Sugar Land Texas
United States Pfizer Investigational Site Thornton Colorado
United States Pfizer Investigational Site Tucson Arizona
United States Pfizer Investigational Site Tucson Arizona
United States Pfizer Investigational Site Tucson Arizona
United States Pfizer Investigational Site Tucson Arizona
United States Pfizer Investigational Site Tucson Arizona
United States Pfizer Investigational Site Tyler Texas
United States Pfizer Investigational Site Weslaco Texas

Sponsors (2)

Lead Sponsor Collaborator
Pfizer International Collaborative Cancer Group (ICCG)

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Bosnia and Herzegovina,  Bulgaria,  Croatia,  Czech Republic,  Denmark,  Egypt,  Estonia,  France,  Germany,  Greece,  Hong Kong,  Hungary,  Ireland,  Israel,  Italy,  Luxembourg,  Malta,  Netherlands,  New Zealand,  Norway,  Peru,  Poland,  Portugal,  Romania,  Russian Federation,  Serbia,  Slovakia,  Slovenia,  South Africa,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline up to Month 36 No
Secondary 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. Baseline up to Month 120 No
Secondary 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. Baseline up to Month 120 No
Secondary 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. Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment Yes
Secondary 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. Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment Yes
Secondary 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. Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment Yes
Secondary 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. 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 Yes
Secondary 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. 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 Yes
Secondary 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. 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 Yes
Secondary 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. 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 Yes
Secondary 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. 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 No
Secondary Number of Participants With Fracture: Bone Metabolism Sub-study Baseline up to 24 months post-treatment Yes
Secondary 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. Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization No
Secondary 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. Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization No
Secondary 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. Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization Yes
Secondary 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. Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization No
Secondary 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. Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization No
Secondary 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. Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization No
Secondary 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. Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization No
Secondary 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. Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization No
Secondary 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. Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization No
Secondary 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. Baseline up to 24 months after randomization No
Secondary 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. 6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment Yes
Secondary 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. Baseline, 6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment Yes
Secondary 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. 6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment Yes
Secondary 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. 6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment Yes
Secondary Percentage of Participants With at Least 1 Gynecological Symptoms: Endometrial Sub-study Gynecological symptoms included bleeding/spotting, pelvic pain, leucorrhoea and vaginal itching. Baseline up to 24 months post-treatment Yes
Secondary Number of Participants With Histological Findings: Endometrial Sub-study Baseline up to 24 months post-treatment Yes
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