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

This study has been completed.
Sponsor:
Collaborator:
International Collaborative Cancer Group (ICCG)
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00038467
First received: May 31, 2002
Last updated: April 21, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention Phase
Breast Neoplasms
Drug: Tamoxifen
Drug: Exemestane
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Double-Blind Trial In Postmenopausal Women With Primary Breast Cancer Who Have Received Adjuvant Tamoxifen For 2-3 Years, Comparing Subsequent Adjuvant Exemestane Treatment With Further Tamoxifen

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Disease-Free Survival (DFS) at Month 36 Post-Randomization: Main Study [ Time Frame: Baseline up to Month 36 ] [ Designated as safety issue: No ]
    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 Participants withdrawn from the study for any reason in the absence of relapse were censored at the date they were last seen.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.


Secondary Outcome Measures:
  • Overall Survival (OS) at Month 36 Post-Randomization: Main Study [ Time Frame: Baseline up to Month 120 ] [ Designated as safety issue: No ]
    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.

  • Number of Events of Second Breast Cancer in Contralateral Breast: Main Study [ Time Frame: Baseline up to Month 120 ] [ Designated as safety issue: No ]
    Number of events of second primary breast cancer in contralateral breast (excluding ductal carcinoma in situ) were reported.

  • 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 [ Time Frame: Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment ] [ Designated as safety issue: Yes ]
    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.

  • 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 [ Time Frame: Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment ] [ Designated as safety issue: Yes ]
    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.

  • 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 [ Time Frame: Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment ] [ Designated as safety issue: Yes ]
    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.

  • Percentage of Bone Specific Alkaline Phosphatase (BAP) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
    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.

  • Percentage of C-Terminal Telopeptide (CTX) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
    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.

  • Percentage of Osteocalcin (OC) and Procollagen T1 C-Peptide (PICP) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
    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.

  • Percentage of Deoxy-pyridinoline (DPD) Urine Concentration Relative to Baseline: Bone Metabolism Sub-study [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
    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.

  • Percentage of N-telopeptide of Type 1 Collagen (NTX) Urine Concentration Relative to Baseline: Bone Metabolism Sub-study [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Fracture: Bone Metabolism Sub-study [ Time Frame: Baseline up to 24 months post-treatment ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Treatment Outcome Index (TOI) at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study [ Time Frame: Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization ] [ Designated as safety issue: Yes ]
    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.

  • 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 [ Time Frame: Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Severe Endocrine Symptoms: QoL Sub-study [ Time Frame: Baseline up to 24 months after randomization ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Endometrial Thickness Greater Than or Equal to (>=) 5 Millimeter (mm): Endometrial Sub-study [ Time Frame: 6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment ] [ Designated as safety issue: Yes ]
    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.

  • Endometrial Thickness: Endometrial Sub-study [ Time Frame: Baseline, 6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment ] [ Designated as safety issue: Yes ]
    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.

  • Uterine and Overall Ovary Volume: Endometrial Sub-study [ Time Frame: 6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment ] [ Designated as safety issue: Yes ]
    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.

  • Number of Participants With Polyps, Fibroids and Ovarian Cysts: Endometrial Sub-study [ Time Frame: 6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment ] [ Designated as safety issue: Yes ]
    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.

  • Percentage of Participants With at Least 1 Gynecological Symptoms: Endometrial Sub-study [ Time Frame: Baseline up to 24 months post-treatment ] [ Designated as safety issue: Yes ]
    Gynecological symptoms included bleeding/spotting, pelvic pain, leucorrhoea and vaginal itching.

  • Number of Participants With Histological Findings: Endometrial Sub-study [ Time Frame: Baseline up to 24 months post-treatment ] [ Designated as safety issue: Yes ]

Enrollment: 4740
Study Start Date: February 1998
Study Completion Date: March 2013
Primary Completion Date: June 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: B Drug: Tamoxifen
Tamoxifen 20 mg/day tablets administered p.o. for a period ranging from 2.5 to 3 years.
Experimental: A Drug: Exemestane
Exemestane 25 mg/day tablets administered p.o. for a period ranging from 2.5 to 3 years.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • unresectable breast cancer
  • ER negative primary tumor
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00038467

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Locations
United States, Alabama
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Birmingham, Alabama, United States, 35235
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Birmingham, Alabama, United States, 35213
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Birmingham, Alabama, United States, 35205
United States, Arizona
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Green Valley, Arizona, United States, 85614
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Green Velley, Arizona, United States, 85614
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Tucson, Arizona, United States, 85745
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Tucson, Arizona, United States, 85710
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Tucson, Arizona, United States, 85715
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Tucson, Arizona, United States, 85712
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Tucson, Arizona, United States, 85704
United States, Colorado
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Boulder, Colorado, United States, 80304
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Colorado Springs, Colorado, United States, 80909
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Denver, Colorado, United States, 80218
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Fort Collins, Colorado, United States, 80528
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Lakewood, Colorado, United States, 80228
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Thornton, Colorado, United States, 80260
United States, Florida
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Jacksonville, Florida, United States, 32207
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Jacksonville, Florida, United States, 32204
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Jacksonville Beach, Florida, United States, 32250
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Ocala, Florida, United States, 34474
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Orange Park, Florida, United States, 32073
United States, Indiana
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Fishers, Indiana, United States, 46038
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Fishers, Indiana, United States, 46037
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Indianapolis, Indiana, United States, 46227
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Indianapolis, Indiana, United States, 46219
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Indianapolis, Indiana, United States, IN 46219
United States, Iowa
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Cedar Rapids, Iowa, United States, 52403
United States, Massachusetts
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Pittsfield, Massachusetts, United States, 01201
United States, New York
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Albany, New York, United States, 12206
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Latham, New York, United States, 12110-0610
United States, Oregon
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Portland, Oregon, United States, 97225
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Portland, Oregon, United States, 97227
United States, Texas
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Arlington, Texas, United States, 76014-2084
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Bedford, Texas, United States, 76022
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Dallas, Texas, United States, 75230-2510
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Dallas, Texas, United States, 75231
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Dallas, Texas, United States, 75246
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El Paso, Texas, United States, 79915
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El Paso, Texas, United States, 79902
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Garland, Texas, United States, 75042
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Houston, Texas, United States, 77030
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Houston, Texas, United States, 77029
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Houston, Texas, United States, 77074
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Houston, Texas, United States, 77024
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Longview, Texas, United States, 75601
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McAllen, Texas, United States, 78503
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Mesquite, Texas, United States, 75150
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Odessa, Texas, United States, 79761
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Pasadena, Texas, United States, 77502
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Plano, Texas, United States, 75075-7787
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San Antonio, Texas, United States, 78217
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Sherman, Texas, United States, 75090
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Sugar Land, Texas, United States, 77479
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Tyler, Texas, United States, 75702
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Weslaco, Texas, United States, 78596
United States, Washington
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Spokane, Washington, United States, 99202
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Spokane, Washington, United States, 99218
Argentina
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Haedo, Buenos Aires, Argentina, 1706
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San Isidro, Buenos Aires, Argentina, 1642
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San Martin, Buenos Aires, Argentina, 1650
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Buenos Aires, Capital Federal, Argentina, 1425
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Buenos Aires, Capital Federal, Argentina, 1417
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Buenos Aires, Capital Federal, Argentina, 1406
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Buenos Aires, Capital Federal, Argentina
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Buenos Aires, Capital Federal, Argentina, 1426
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Rosario 2000, Pcia. de Santa Fe, Argentina
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Rosario, Santa Fe, Argentina, 2000
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Buenos Aires, Argentina, 1181
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Cordoba, Argentina, X5000AA1
Australia, New South Wales
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Camperdown, New South Wales, Australia, 2050
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Dubbo, New South Wales, Australia, 2830
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Liverpool, New South Wales, Australia, 2170
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Waratah, New South Wales, Australia, 2298
Australia, South Australia
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Adelaide, South Australia, Australia, 5000
Australia, Victoria
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Bendigo, Victoria, Australia, 3552
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Box Hill, Victoria, Australia, 3128
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Ringwood East, Victoria, Australia, 3135
Belgium
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Antwerpen, Belgium, 2020
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Arlon, Belgium, 6700
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Baudour, Belgium, 7331
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Brasschaat, Belgium, 2930
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Bruxelles, Belgium, 1000
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Bruxelles, Belgium, 1180
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Charleroi, Belgium, 6000
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Edegem, Belgium, 2650
Pfizer Investigational Site
Genk, Belgium, 3600
Pfizer Investigational Site
Haine St. Paul, Belgium, 7100
Pfizer Investigational Site
Hasselt, Belgium, 3500
Pfizer Investigational Site
Kraainem, Belgium, 1950
Pfizer Investigational Site
La Louviere, Belgium, 7100
Pfizer Investigational Site
Leuven, Belgium, 3000
Pfizer Investigational Site
Liege, Belgium, 4000
Pfizer Investigational Site
Merksem, Belgium, 2170
Pfizer Investigational Site
Namur, Belgium, 5000
Pfizer Investigational Site
Verviers, Belgium, 4800
Pfizer Investigational Site
Wilrijk, Belgium, 2610
Bosnia and Herzegovina
Pfizer Investigational Site
Sarajevo, Bosnia and Herzegovina, 71000
Bulgaria
Pfizer Investigational Site
Plovdiv, Bulgaria, 4004
Pfizer Investigational Site
Sofia, Bulgaria, 1504
Pfizer Investigational Site
Sofia, Bulgaria, 1784
Pfizer Investigational Site
Sofia, Bulgaria, 1756
Pfizer Investigational Site
Stara Zagora, Bulgaria, 6003
Croatia
Pfizer Investigational Site
Osijek, Croatia
Pfizer Investigational Site
Split, Croatia
Pfizer Investigational Site
Zagreb, Croatia, 10000
Pfizer Investigational Site
Zagreb, Croatia
Czech Republic
Pfizer Investigational Site
Brno, Czech Republic, 656 53
Pfizer Investigational Site
Ceske Budejovice, Czech Republic, 370 87
Pfizer Investigational Site
Prague 2, Czech Republic, 12808
Denmark
Pfizer Investigational Site
Aarhus C, Denmark, 8000
Pfizer Investigational Site
Esbjerg, Denmark, 6700
Pfizer Investigational Site
Herlev, Denmark, 2730
Pfizer Investigational Site
Herning, Denmark, 7400
Pfizer Investigational Site
Hilleroed, Denmark, 3400
Pfizer Investigational Site
Koebenhavn OE, Denmark, 2100
Pfizer Investigational Site
Naestved, Denmark, 4700
Pfizer Investigational Site
Roskilde, Denmark, 4000
Pfizer Investigational Site
Vejle, Denmark, 7100
Pfizer Investigational Site
Viborg, Denmark, 8800
Egypt
Pfizer Investigational Site
Cairo, Egypt
Estonia
Pfizer Investigational Site
Tartu, Estonia, 51014
France
Pfizer Investigational Site
Angers, France, 49033 Cedex 01
Pfizer Investigational Site
Annecy Cedex, France, 74011
Pfizer Investigational Site
Avignon Cedex 2, France, 84082
Pfizer Investigational Site
Bordeaux, France, 33300 Cedex
Pfizer Investigational Site
Bordeaux, France, 33030 Cedex
Pfizer Investigational Site
Brest, France, 29609 Cedex
Pfizer Investigational Site
Caen, France, 14052 Cedex
Pfizer Investigational Site
Caen Cedex 05, France, 14076
Pfizer Investigational Site
Clermont Ferrand, France, 63011
Pfizer Investigational Site
Evreux, France, 27000
Pfizer Investigational Site
Lagny Sur Marne, France, 77405 Cedex
Pfizer Investigational Site
Le Havre, France, 76600
Pfizer Investigational Site
Le Mans, France, 72000
Pfizer Investigational Site
Lille, France, 59020 Cedex
Pfizer Investigational Site
Lyon, France, 69373
Pfizer Investigational Site
Marseille, France, 13273
Pfizer Investigational Site
Meaux, France, 77100
Pfizer Investigational Site
Montbeliard, France, 25209 Cedex
Pfizer Investigational Site
Mulhouse, France, 68070 Cedex
Pfizer Investigational Site
Nice, France, 06189
Pfizer Investigational Site
Paris, France, 75248 Cedex 5
Pfizer Investigational Site
Paris, France, 75970 Cedex 20
Pfizer Investigational Site
Perpignan, France, 66046
Pfizer Investigational Site
Rennes, France, 35042
Pfizer Investigational Site
Rouen, France, 76038 Cedex
Pfizer Investigational Site
Saint-Herblain, France, 44805
Pfizer Investigational Site
St Cloud, France, 92210
Pfizer Investigational Site
Strasbourg, France, 67091 Cedex
Pfizer Investigational Site
Toulouse, France, 31502
Germany
Pfizer Investigational Site
Berlin, Germany, 13353
Pfizer Investigational Site
Berlin, Germany, 10117
Pfizer Investigational Site
Chemnitz, Germany, 09126
Pfizer Investigational Site
Erlangen, Germany, 91054
Pfizer Investigational Site
Freiburg, Germany, 79106
Pfizer Investigational Site
Gera, Germany, 07548
Pfizer Investigational Site
Greiz, Germany, 07973
Pfizer Investigational Site
Halle, Germany, 06110
Pfizer Investigational Site
Halle, Germany, 06120
Pfizer Investigational Site
Hamburg, Germany, 22081
Pfizer Investigational Site
Hildburghausen, Germany, 98646
Pfizer Investigational Site
Leipzig, Germany, 04129
Pfizer Investigational Site
Luebeck, Germany, 23538
Pfizer Investigational Site
Muenchen, Germany, 80335
Pfizer Investigational Site
Riesa, Germany, 01589
Pfizer Investigational Site
Rodewisch, Germany, 08228
Pfizer Investigational Site
Saarbruecken, Germany, 66113
Pfizer Investigational Site
Suhl, Germany, 98527
Pfizer Investigational Site
Weiden, Germany, 92637
Greece
Pfizer Investigational Site
Athens, Attiki, Greece, 115 28
Pfizer Investigational Site
Athens, Attiki, Greece, 115 22
Pfizer Investigational Site
Heraklion, Crete, Greece, 71 110
Hong Kong
Pfizer Investigational Site
New Territories, Hong Kong
Hungary
Pfizer Investigational Site
Budapest, Hungary, 1082
Pfizer Investigational Site
Budapest, Hungary, 1122
Pfizer Investigational Site
Budapest, Hungary, 1145
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, Ireland
Israel
Pfizer Investigational Site
Haifa, Israel
Pfizer Investigational Site
Haifa, Israel, 34362
Pfizer Investigational Site
Jerusalem, Israel, 91120
Pfizer Investigational Site
Jerusalem, Israel
Pfizer Investigational Site
Kfar Saba, Israel
Pfizer Investigational Site
Petah Tikva, Israel
Pfizer Investigational Site
Rehovot, Israel
Italy
Pfizer Investigational Site
Carpi, Modena, Italy, 41012
Pfizer Investigational Site
Alba (CN), Italy, 12051
Pfizer Investigational Site
Aviano (PN), Italy, 33081
Pfizer Investigational Site
Bergamo, Italy, 24128
Pfizer Investigational Site
Biella, Italy, 13900
Pfizer Investigational Site
Cagliari, Italy, 09121
Pfizer Investigational Site
Casale Monferrato, AL, Italy, 15033
Pfizer Investigational Site
Correggio, Italy, 42015
Pfizer Investigational Site
Cremona, Italy, 26100
Pfizer Investigational Site
Cuneo, Italy, 12100
Pfizer Investigational Site
Fermo FM, Italy, 63023
Pfizer Investigational Site
Firenze, Italy, 50134
Pfizer Investigational Site
Genova, Italy, 16132
Pfizer Investigational Site
Genova, Italy, 16128
Pfizer Investigational Site
Lecco, Italy, 23900
Pfizer Investigational Site
Lodi, Italy, 20075
Pfizer Investigational Site
Mantova, Italy, 46100
Pfizer Investigational Site
Milano, Italy, 20141
Pfizer Investigational Site
Milano, Italy, 20121
Pfizer Investigational Site
Milano, Italy, 21053
Pfizer Investigational Site
Milano, Italy, 20133
Pfizer Investigational Site
Modena, Italy, 41100
Pfizer Investigational Site
Monserrato (CA), Italy, 09042
Pfizer Investigational Site
Monza, Italy, 20052
Pfizer Investigational Site
Napoli, Italy, 80131
Pfizer Investigational Site
Palermo, Italy, 90139
Pfizer Investigational Site
Parma, Italy, 43100
Pfizer Investigational Site
Perugia, Italy, 06132
Pfizer Investigational Site
Piacenza, Italy, 29100
Pfizer Investigational Site
Pietra Ligure (SV), Italy, 17027
Pfizer Investigational Site
Pisa, Italy, 56100
Pfizer Investigational Site
Reggio Emilia, Italy, 42100
Pfizer Investigational Site
Roma, Italy, 00148
Pfizer Investigational Site
Sassari, Italy, 07100
Pfizer Investigational Site
Terni, Italy, 05100
Pfizer Investigational Site
Thiene (VI), Italy, 36016
Pfizer Investigational Site
Torino, Italy, 10126
Pfizer Investigational Site
Tortona, Italy, 15057
Pfizer Investigational Site
Trescore Balneario BG, Italy, 24069
Pfizer Investigational Site
Treviglio (BG), Italy, 24047
Pfizer Investigational Site
Varese, Italy, 21100
Luxembourg
Pfizer Investigational Site
Luxembourg, Luxembourg, 1210
Malta
Pfizer Investigational Site
Floriana, Malta, VLT 14
Netherlands
Pfizer Investigational Site
Amersfoort, Netherlands, 3818 ES
Pfizer Investigational Site
Amsterdam, Netherlands, 1061 AE
Pfizer Investigational Site
Amsterdam, Netherlands, 1105 AZ
Pfizer Investigational Site
Amsterdam, Netherlands, 1066 CX
Pfizer Investigational Site
Apeldoorn, Netherlands, 7300 DS
Pfizer Investigational Site
Blaricum, Netherlands, 1261 AN
Pfizer Investigational Site
Breda, Netherlands, 4818 CK
Pfizer Investigational Site
Delft, Netherlands, 2625 AD
Pfizer Investigational Site
Den Haag, Netherlands, 2545 CH
Pfizer Investigational Site
Eindhoven, Netherlands, 5623 EJ
Pfizer Investigational Site
Enschede, Netherlands, 7513 ER
Pfizer Investigational Site
Groningen, Netherlands, 9700 RM
Pfizer Investigational Site
Groningen, Netherlands, 9728 NZ
Pfizer Investigational Site
Hengelo, Netherlands, 7555 DL
Pfizer Investigational Site
Leeuwarden, Netherlands, 8934 AD
Pfizer Investigational Site
Leiden, Netherlands, 2333 ZA
Pfizer Investigational Site
Leidschendam, Netherlands, 2262 BA
Pfizer Investigational Site
Podybus 90153, Netherlands, 5200 ME Den Bosch
Pfizer Investigational Site
Roermond, Netherlands, 6043 CV
Pfizer Investigational Site
Sittard, Netherlands, 6131 BK
Pfizer Investigational Site
Utrecht, Netherlands, 3582 KE
Pfizer Investigational Site
Veldhoven, Netherlands, 5504 DB
Pfizer Investigational Site
Zaandam, Netherlands, 1502 DV
New Zealand
Pfizer Investigational Site
Hamilton, Waikato, New Zealand, 2021
Pfizer Investigational Site
Auckland, New Zealand, 1142
Norway
Pfizer Investigational Site
Bergen, Norway, 5021
Pfizer Investigational Site
Bodo, Norway, 8092
Pfizer Investigational Site
Fredrikstad, Norway, 1603
Pfizer Investigational Site
Haugesund, Norway, 5390
Pfizer Investigational Site
Levanger, Norway, 7600
Pfizer Investigational Site
Mo i Rana, Norway, 8607
Pfizer Investigational Site
Molde, Norway, 6407
Pfizer Investigational Site
Notodden, Norway, 3674
Pfizer Investigational Site
Oslo, Norway
Pfizer Investigational Site
Rissa, Norway, 7100
Pfizer Investigational Site
Rjukan, Norway, 3660
Pfizer Investigational Site
Sandefjord, Norway
Pfizer Investigational Site
Tonsberg, Norway, 3103
Pfizer Investigational Site
Tromso, Norway, 9038
Pfizer Investigational Site
Tromsø, Norway, 9038
Peru
Pfizer Investigational Site
Lima, Peru, L34
Poland
Pfizer Investigational Site
Gdansk, Poland, 80-952
Pfizer Investigational Site
Gliwice, Poland, 44-101
Pfizer Investigational Site
Krakow, Poland, 31-826
Pfizer Investigational Site
Krakow, Poland, 31-115
Pfizer Investigational Site
Lodz, Poland, 93-509
Pfizer Investigational Site
Opole, Poland, 45-060
Pfizer Investigational Site
Poznan, Poland, 61-878
Pfizer Investigational Site
Sopot, Poland, 81-756
Pfizer Investigational Site
Warszawa, Poland, 02-781
Portugal
Pfizer Investigational Site
Coimbra, Portugal, 3040
Pfizer Investigational Site
Coimbra, Portugal
Pfizer Investigational Site
Evora, Portugal, 7000-811
Romania
Pfizer Investigational Site
Bucuresti, Romania, 72435
Pfizer Investigational Site
Cluj Napoca, Romania, 400015
Pfizer Investigational Site
Timisoara, Romania, 300223
Russian Federation
Pfizer Investigational Site
St. Petersburg, Russian Federation, 197758
Serbia
Pfizer Investigational Site
Belgrade, Serbia, 11000
Pfizer Investigational Site
Sremska Kamenica, Serbia, 21204
Slovakia
Pfizer Investigational Site
Banska Bystrica, Slovakia, 97517
Pfizer Investigational Site
Bratislava, Slovakia, SK-83310
Pfizer Investigational Site
Kosice, Slovakia, 041 90
Slovenia
Pfizer Investigational Site
Ljubljana, Slovenia, 1000
South Africa
Pfizer Investigational Site
Johannesburg, Gauteng, South Africa, 2196
Pfizer Investigational Site
Observatory, South Africa, 7925
Spain
Pfizer Investigational Site
Alcoy, Alicante, Spain, 03804
Pfizer Investigational Site
Elche, Alicante, Spain, 03203
Pfizer Investigational Site
San Juan de Alicante, Alicante, Spain, 03550
Pfizer Investigational Site
Sant Joan D'Alacant, Alicante, Spain, 03550
Pfizer Investigational Site
Badalona, Barcelona, Spain, 08911
Pfizer Investigational Site
Badalona, Barcelona, Spain, 08916
Pfizer Investigational Site
Terrassa, Barcelona, Spain, 08227
Pfizer Investigational Site
Terrassa, Barcelona, Spain, 08221
Pfizer Investigational Site
San Sebastian, Guipuzcoa, Spain, 20014
Pfizer Investigational Site
Barbastro, Huesca, Spain, 22300
Pfizer Investigational Site
Reus, Tarragona, Spain, 43201
Pfizer Investigational Site
Albacete, Spain, 02006
Pfizer Investigational Site
Alicante, Spain, 03010
Pfizer Investigational Site
Badajoz, Spain, 06080
Pfizer Investigational Site
Badajoz, Spain, 06008
Pfizer Investigational Site
Cordoba, Spain, 14004
Pfizer Investigational Site
Guadalajara, Spain, 19002
Pfizer Investigational Site
Lleida, Spain, 25198
Pfizer Investigational Site
Madrid, Spain, 28040
Pfizer Investigational Site
Madrid, Spain, 28041
Pfizer Investigational Site
Madrid, Spain, 28034
Pfizer Investigational Site
Valencia, Spain, 46014
Pfizer Investigational Site
Zaragoza, Spain, 50009
Sweden
Pfizer Investigational Site
Boras, Sweden, 501 82
Pfizer Investigational Site
Borås, Sweden, 50182
Pfizer Investigational Site
Goteborg, Sweden, 413 45
Pfizer Investigational Site
Halmstad, Sweden, 301 85
Pfizer Investigational Site
Helsingborg, Sweden, 251 87
Pfizer Investigational Site
Kristianstad, Sweden, 291 85
Pfizer Investigational Site
Linkoping, Sweden, 581 85
Pfizer Investigational Site
Lund, Sweden, 221 85
Pfizer Investigational Site
Malmo, Sweden, 205 02
Pfizer Investigational Site
Motala, Sweden, 591 85
Pfizer Investigational Site
Norrkoping, Sweden, 601 82
Pfizer Investigational Site
Nässjö, Sweden, 575 81
Pfizer Investigational Site
Varnamo, Sweden, 331 85
Pfizer Investigational Site
Vasteras, Sweden, 721 89
Pfizer Investigational Site
Vastervik, Sweden, 59381
Pfizer Investigational Site
Vaxjo, Sweden, 351 85
Switzerland
Pfizer Investigational Site
Basel, Switzerland, CH-4031
Pfizer Investigational Site
Bellinzona, Switzerland, CH-6500
Pfizer Investigational Site
Bern, Switzerland, 3010
Pfizer Investigational Site
Bern, Switzerland, CH-3012
Pfizer Investigational Site
Genève, Switzerland, CH-1211
United Kingdom
Pfizer Investigational Site
Huntingdon, Cambs, United Kingdom, PE18 8NT
Pfizer Investigational Site
Bournemouth, Dorset, United Kingdom, BH7 7DW
Pfizer Investigational Site
Hull, East Yorkshire, United Kingdom, HU16 5JQ
Pfizer Investigational Site
Epping, Essex, United Kingdom, CM166TN
Pfizer Investigational Site
Westcliff-On-Sea, Essex, United Kingdom, SS0 0RY
Pfizer Investigational Site
Newport, Gwent, United Kingdom, NP6 2UB
Pfizer Investigational Site
Bangor, Gwynedd, United Kingdom, LL57 2PW
Pfizer Investigational Site
Salterhebble, Halifax, United Kingdom, HX6 0PW
Pfizer Investigational Site
Gosport, Hants, United Kingdom, PO12 2AA
Pfizer Investigational Site
Northwood, Middlesex, United Kingdom, HA6 2RN
Pfizer Investigational Site
Londonderry, N. Ireland, United Kingdom, BT47 1SB
Pfizer Investigational Site
Harrogate, N. Yorkshire, United Kingdom, HG2 7SX
Pfizer Investigational Site
Taunton, Somerset, United Kingdom, TA1 5DA
Pfizer Investigational Site
Swansea, South Wales, United Kingdom, SA2 8QA
Pfizer Investigational Site
York, Yorkshire, United Kingdom, Y03 7He
Pfizer Investigational Site
Belfast, United Kingdom, BT97AB
Pfizer Investigational Site
Bradford, United Kingdom, BD9 6RJ
Pfizer Investigational Site
Bristol, United Kingdom, BS10 5NB
Pfizer Investigational Site
Cardiff, United Kingdom, CF14 2TL
Pfizer Investigational Site
Coventry, United Kingdom, CV2 2DX
Pfizer Investigational Site
East Kilbride, United Kingdom, G75 8RG
Pfizer Investigational Site
Huddersfield, United Kingdom, HD3 3EA
Pfizer Investigational Site
Leeds, United Kingdom, LS9 7TF
Pfizer Investigational Site
Leeds, United Kingdom, LS1 3EX
Pfizer Investigational Site
Lincoln, United Kingdom
Pfizer Investigational Site
London, United Kingdom, N18 1QX
Pfizer Investigational Site
London, United Kingdom, N19 5NF
Pfizer Investigational Site
London, United Kingdom, NW3 2QG
Pfizer Investigational Site
London, United Kingdom, SW17 0QT
Pfizer Investigational Site
London, United Kingdom, W6 8RF
Pfizer Investigational Site
Luton, United Kingdom, LU4 0DZ
Pfizer Investigational Site
Manchester, United Kingdom, M20 4BX
Pfizer Investigational Site
Sheffield, United Kingdom, S10 2SJ
Pfizer Investigational Site
Shrewsbury, United Kingdom
Pfizer Investigational Site
Somerset, United Kingdom, BA21 4AT
Pfizer Investigational Site
Southampton, United Kingdom, S016 6YD
Pfizer Investigational Site
Steeton, United Kingdom, BD20 6TD
Pfizer Investigational Site
Stoke on Trent, United Kingdom, ST4 6QG
Pfizer Investigational Site
Telford, United Kingdom, TF1 6TF
Pfizer Investigational Site
Wythenshawe, Manchester, United Kingdom, M23 9LT
Sponsors and Collaborators
Pfizer
International Collaborative Cancer Group (ICCG)
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00038467     History of Changes
Other Study ID Numbers: 96-OEXE-031, A5991012
Study First Received: May 31, 2002
Results First Received: March 5, 2014
Last Updated: April 21, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Tamoxifen
Exemestane
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents
Estrogen Antagonists
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 29, 2014