Randomized Trial Of Exemestane Versus Continued Tamoxifen In Postmenopausal Women With Early Breast Cancer (IES)
maanantai 21. huhtikuuta 2014 päivittänyt: Pfizer
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.
Tutkimuksen yleiskatsaus
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
4740
Vaihe
- Vaihe 3
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
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Alba (CN), Italia, 12051
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Biella, Italia, 13900
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St. Petersburg, Venäjän federaatio, 197758
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Tartu, Viro, 51014
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- Pfizer Investigational Site
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Telford, Yhdistynyt kuningaskunta, TF1 6TF
- Pfizer Investigational Site
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Wythenshawe, Manchester, Yhdistynyt kuningaskunta, M23 9LT
- Pfizer Investigational Site
-
-
Cambs
-
Huntingdon, Cambs, Yhdistynyt kuningaskunta, PE18 8NT
- Pfizer Investigational Site
-
-
Dorset
-
Bournemouth, Dorset, Yhdistynyt kuningaskunta, BH7 7DW
- Pfizer Investigational Site
-
-
East Yorkshire
-
Hull, East Yorkshire, Yhdistynyt kuningaskunta, HU16 5JQ
- Pfizer Investigational Site
-
-
Essex
-
Epping, Essex, Yhdistynyt kuningaskunta, CM166TN
- Pfizer Investigational Site
-
Westcliff-On-Sea, Essex, Yhdistynyt kuningaskunta, SS0 0RY
- Pfizer Investigational Site
-
-
Gwent
-
Newport, Gwent, Yhdistynyt kuningaskunta, NP6 2UB
- Pfizer Investigational Site
-
-
Gwynedd
-
Bangor, Gwynedd, Yhdistynyt kuningaskunta, LL57 2PW
- Pfizer Investigational Site
-
-
Halifax
-
Salterhebble, Halifax, Yhdistynyt kuningaskunta, HX6 0PW
- Pfizer Investigational Site
-
-
Hants
-
Gosport, Hants, Yhdistynyt kuningaskunta, PO12 2AA
- Pfizer Investigational Site
-
-
Middlesex
-
Northwood, Middlesex, Yhdistynyt kuningaskunta, HA6 2RN
- Pfizer Investigational Site
-
-
N. Ireland
-
Londonderry, N. Ireland, Yhdistynyt kuningaskunta, BT47 1SB
- Pfizer Investigational Site
-
-
N. Yorkshire
-
Harrogate, N. Yorkshire, Yhdistynyt kuningaskunta, HG2 7SX
- Pfizer Investigational Site
-
-
Somerset
-
Taunton, Somerset, Yhdistynyt kuningaskunta, TA1 5DA
- Pfizer Investigational Site
-
-
South Wales
-
Swansea, South Wales, Yhdistynyt kuningaskunta, SA2 8QA
- Pfizer Investigational Site
-
-
Yorkshire
-
York, Yorkshire, Yhdistynyt kuningaskunta, Y03 7He
- Pfizer Investigational Site
-
-
-
-
Alabama
-
Birmingham, Alabama, Yhdysvallat, 35205
- Pfizer Investigational Site
-
Birmingham, Alabama, Yhdysvallat, 35213
- Pfizer Investigational Site
-
Birmingham, Alabama, Yhdysvallat, 35235
- Pfizer Investigational Site
-
-
Arizona
-
Green Valley, Arizona, Yhdysvallat, 85614
- Pfizer Investigational Site
-
Green Velley, Arizona, Yhdysvallat, 85614
- Pfizer Investigational Site
-
Tucson, Arizona, Yhdysvallat, 85715
- Pfizer Investigational Site
-
Tucson, Arizona, Yhdysvallat, 85712
- Pfizer Investigational Site
-
Tucson, Arizona, Yhdysvallat, 85710
- Pfizer Investigational Site
-
Tucson, Arizona, Yhdysvallat, 85704
- Pfizer Investigational Site
-
Tucson, Arizona, Yhdysvallat, 85745
- Pfizer Investigational Site
-
-
Colorado
-
Boulder, Colorado, Yhdysvallat, 80304
- Pfizer Investigational Site
-
Colorado Springs, Colorado, Yhdysvallat, 80909
- Pfizer Investigational Site
-
Denver, Colorado, Yhdysvallat, 80218
- Pfizer Investigational Site
-
Fort Collins, Colorado, Yhdysvallat, 80528
- Pfizer Investigational Site
-
Lakewood, Colorado, Yhdysvallat, 80228
- Pfizer Investigational Site
-
Thornton, Colorado, Yhdysvallat, 80260
- Pfizer Investigational Site
-
-
Florida
-
Jacksonville, Florida, Yhdysvallat, 32207
- Pfizer Investigational Site
-
Jacksonville, Florida, Yhdysvallat, 32204
- Pfizer Investigational Site
-
Jacksonville Beach, Florida, Yhdysvallat, 32250
- Pfizer Investigational Site
-
Ocala, Florida, Yhdysvallat, 34474
- Pfizer Investigational Site
-
Orange Park, Florida, Yhdysvallat, 32073
- Pfizer Investigational Site
-
-
Indiana
-
Fishers, Indiana, Yhdysvallat, 46038
- Pfizer Investigational Site
-
Fishers, Indiana, Yhdysvallat, 46037
- Pfizer Investigational Site
-
Indianapolis, Indiana, Yhdysvallat, 46227
- Pfizer Investigational Site
-
Indianapolis, Indiana, Yhdysvallat, 46219
- Pfizer Investigational Site
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Indianapolis, Indiana, Yhdysvallat, IN 46219
- Pfizer Investigational Site
-
-
Iowa
-
Cedar Rapids, Iowa, Yhdysvallat, 52403
- Pfizer Investigational Site
-
-
Massachusetts
-
Pittsfield, Massachusetts, Yhdysvallat, 01201
- Pfizer Investigational Site
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-
New York
-
Albany, New York, Yhdysvallat, 12206
- Pfizer Investigational Site
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Latham, New York, Yhdysvallat, 12110-0610
- Pfizer Investigational Site
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-
Oregon
-
Portland, Oregon, Yhdysvallat, 97225
- Pfizer Investigational Site
-
Portland, Oregon, Yhdysvallat, 97227
- Pfizer Investigational Site
-
-
Texas
-
Arlington, Texas, Yhdysvallat, 76014-2084
- Pfizer Investigational Site
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Bedford, Texas, Yhdysvallat, 76022
- Pfizer Investigational Site
-
Dallas, Texas, Yhdysvallat, 75231
- Pfizer Investigational Site
-
Dallas, Texas, Yhdysvallat, 75230-2510
- Pfizer Investigational Site
-
Dallas, Texas, Yhdysvallat, 75246
- Pfizer Investigational Site
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El Paso, Texas, Yhdysvallat, 79902
- Pfizer Investigational Site
-
El Paso, Texas, Yhdysvallat, 79915
- Pfizer Investigational Site
-
Garland, Texas, Yhdysvallat, 75042
- Pfizer Investigational Site
-
Houston, Texas, Yhdysvallat, 77030
- Pfizer Investigational Site
-
Houston, Texas, Yhdysvallat, 77024
- Pfizer Investigational Site
-
Houston, Texas, Yhdysvallat, 77074
- Pfizer Investigational Site
-
Houston, Texas, Yhdysvallat, 77029
- Pfizer Investigational Site
-
Longview, Texas, Yhdysvallat, 75601
- Pfizer Investigational Site
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McAllen, Texas, Yhdysvallat, 78503
- Pfizer Investigational Site
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Mesquite, Texas, Yhdysvallat, 75150
- Pfizer Investigational Site
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Odessa, Texas, Yhdysvallat, 79761
- Pfizer Investigational Site
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Pasadena, Texas, Yhdysvallat, 77502
- Pfizer Investigational Site
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Plano, Texas, Yhdysvallat, 75075-7787
- Pfizer Investigational Site
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San Antonio, Texas, Yhdysvallat, 78217
- Pfizer Investigational Site
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Sherman, Texas, Yhdysvallat, 75090
- Pfizer Investigational Site
-
Sugar Land, Texas, Yhdysvallat, 77479
- Pfizer Investigational Site
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Tyler, Texas, Yhdysvallat, 75702
- Pfizer Investigational Site
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Weslaco, Texas, Yhdysvallat, 78596
- Pfizer Investigational Site
-
-
Washington
-
Spokane, Washington, Yhdysvallat, 99202
- Pfizer Investigational Site
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Spokane, Washington, Yhdysvallat, 99218
- Pfizer Investigational Site
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-
Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
30 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Nainen
Kuvaus
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
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Kaksinkertainen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Active Comparator: B
|
Tamoxifen 20 mg/day tablets administered p.o. for a period ranging from 2.5 to 3 years.
|
|
Kokeellinen: A
|
Exemestane 25 mg/day tablets administered p.o. for a period ranging from 2.5 to 3 years.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Disease-Free Survival (DFS) at Month 36 Post-Randomization: Main Study
Aikaikkuna: Baseline up to Month 36
|
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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Overall Survival (OS) at Month 36 Post-Randomization: Main Study
Aikaikkuna: Baseline up to Month 120
|
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
|
|
Number of Events of Second Breast Cancer in Contralateral Breast: Main Study
Aikaikkuna: Baseline up to Month 120
|
Number of events of second primary breast cancer in contralateral breast (excluding ductal carcinoma in situ) were reported.
|
Baseline up to Month 120
|
|
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
Aikaikkuna: Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment
|
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
|
|
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
Aikaikkuna: Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment
|
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
|
|
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
Aikaikkuna: Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment
|
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
|
|
Percentage of Bone Specific Alkaline Phosphatase (BAP) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study
Aikaikkuna: 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
|
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
|
|
Percentage of C-Terminal Telopeptide (CTX) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study
Aikaikkuna: 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
|
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
|
|
Percentage of Osteocalcin (OC) and Procollagen T1 C-Peptide (PICP) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study
Aikaikkuna: 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
|
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
|
|
Percentage of Deoxy-pyridinoline (DPD) Urine Concentration Relative to Baseline: Bone Metabolism Sub-study
Aikaikkuna: 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
|
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
|
|
Percentage of N-telopeptide of Type 1 Collagen (NTX) Urine Concentration Relative to Baseline: Bone Metabolism Sub-study
Aikaikkuna: 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
|
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
|
|
Number of Participants With Fracture: Bone Metabolism Sub-study
Aikaikkuna: Baseline up to 24 months post-treatment
|
Baseline up to 24 months post-treatment
|
|
|
Change From Baseline in Treatment Outcome Index (TOI) at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study
Aikaikkuna: Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization
|
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
|
|
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
Aikaikkuna: Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization
|
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
|
|
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
Aikaikkuna: Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization
|
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
|
|
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
Aikaikkuna: Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization
|
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
|
|
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
Aikaikkuna: Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization
|
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
|
|
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
Aikaikkuna: Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization
|
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
|
|
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
Aikaikkuna: Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization
|
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
|
|
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
Aikaikkuna: Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization
|
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
|
|
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
Aikaikkuna: Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization
|
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
|
|
Number of Participants With Severe Endocrine Symptoms: QoL Sub-study
Aikaikkuna: Baseline up to 24 months after randomization
|
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
|
|
Percentage of Participants With Endometrial Thickness Greater Than or Equal to (>=) 5 Millimeter (mm): Endometrial Sub-study
Aikaikkuna: 6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment
|
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
|
|
Endometrial Thickness: Endometrial Sub-study
Aikaikkuna: Baseline, 6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment
|
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
|
|
Uterine and Overall Ovary Volume: Endometrial Sub-study
Aikaikkuna: 6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment
|
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
|
|
Number of Participants With Polyps, Fibroids and Ovarian Cysts: Endometrial Sub-study
Aikaikkuna: 6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment
|
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
|
|
Percentage of Participants With at Least 1 Gynecological Symptoms: Endometrial Sub-study
Aikaikkuna: Baseline up to 24 months post-treatment
|
Gynecological symptoms included bleeding/spotting, pelvic pain, leucorrhoea and vaginal itching.
|
Baseline up to 24 months post-treatment
|
|
Number of Participants With Histological Findings: Endometrial Sub-study
Aikaikkuna: Baseline up to 24 months post-treatment
|
Baseline up to 24 months post-treatment
|
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Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Sunnuntai 1. helmikuuta 1998
Ensisijainen valmistuminen (Todellinen)
Sunnuntai 1. kesäkuuta 2003
Opintojen valmistuminen (Todellinen)
Perjantai 1. maaliskuuta 2013
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Perjantai 31. toukokuuta 2002
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Perjantai 31. toukokuuta 2002
Ensimmäinen Lähetetty (Arvio)
Maanantai 3. kesäkuuta 2002
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Keskiviikko 7. toukokuuta 2014
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Maanantai 21. huhtikuuta 2014
Viimeksi vahvistettu
Tiistai 1. huhtikuuta 2014
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
- Ihosairaudet
- Neoplasmat
- Neoplasmat sivustoittain
- Rintojen sairaudet
- Rintojen kasvaimet
- Huumeiden fysiologiset vaikutukset
- Farmakologisen vaikutuksen molekyylimekanismit
- Entsyymin estäjät
- Antineoplastiset aineet
- Hormonit, hormonikorvikkeet ja hormoniantagonistit
- Antineoplastiset aineet, hormonaaliset
- Hormoniantagonistit
- Luutiheyden säilyttämisaineet
- Aromataasi-inhibiittorit
- Steroidisynteesin estäjät
- Estrogeeniantagonistit
- Selektiiviset estrogeenireseptorimodulaattorit
- Estrogeenireseptorin modulaattorit
- Tamoksifeeni
- Eksemestaani
Muut tutkimustunnusnumerot
- 96-OEXE-031
- A5991012
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