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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00793546
Registration number
NCT00793546
Ethics application status
Date submitted
29/10/2008
Date registered
19/11/2008
Date last updated
4/11/2012
Titles & IDs
Public title
Study Evaluating Bosutinib-Exemestane Combination Vs Exemestane Alone in Post Menopausal Women With Breast Cancer
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Scientific title
A Phase 2, Randomized, Open-Label Study Of Bosutinib Administered In Combination With Exemestane Versus Exemestane Alone As Second Line Therapy In Postmenopausal Women With Locally Advanced Or Metastatic ER+/PgR+/ErbB2- Breast Cancer
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Secondary ID [1]
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B1871009
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Secondary ID [2]
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3160A6-2206
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced Breast Cancer
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Bosutinib
Treatment: Drugs - exemestane
Treatment: Drugs - Exemestane
Experimental: 1 - combination of bosutinib and exemestane
Active Comparator: 2 - exemestane
Treatment: Drugs: Bosutinib
300 mg =(3x100mg) tablets once daily during the active phase of treatment until disease progression, unacceptable toxicity or withdrawal of consent occurs
Treatment: Drugs: exemestane
25 mg tablet once daily
Treatment: Drugs: Exemestane
25 mg - 1 tablet per day- once daily daily during the active phase of treatment until disease progression, unacceptable toxicity or withdrawal of consent occurs
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression Free Survival (PFS) Based on Independent Radiologist
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Assessment method [1]
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Time in weeks from randomization to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of randomization plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death").
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Timepoint [1]
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Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose
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Secondary outcome [1]
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Percentage of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)
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Assessment method [1]
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An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
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Timepoint [1]
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Baseline up to 28 days after the last dose
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Secondary outcome [2]
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Progression Free Survival (PFS) Based on Investigator
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Assessment method [2]
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Time in weeks from randomization to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of randomization plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death").
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Timepoint [2]
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Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose
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Secondary outcome [3]
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Percentage of Participants With Objective Response
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Assessment method [3]
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Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to >=30 percent (%) decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study >=4 weeks after initial documentation of response.
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Timepoint [3]
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Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose
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Secondary outcome [4]
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Overall Survival (OS)
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Assessment method [4]
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Time in weeks from randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).
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Timepoint [4]
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Part 2 Baseline until death or up to 24 months
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Secondary outcome [5]
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Duration of Response (DR)
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Assessment method [5]
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Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.
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Timepoint [5]
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Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose
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Secondary outcome [6]
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Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B)
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Assessment method [6]
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FACT-B is used for assessment of health-related quality of life (QoL) in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and additional concerns on breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures ranges from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
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Timepoint [6]
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Part 2 Baseline, Week 12, 2 to 6 weeks after last dose
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Secondary outcome [7]
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Euro Quality of Life (EQ-5D)- Health State Profile Utility Score
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Assessment method [7]
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EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
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Timepoint [7]
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Part 2 Baseline, Week 12, 2 to 6 weeks after last dose
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Secondary outcome [8]
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Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)
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Assessment method [8]
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EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeter (mm) = worst imaginable health state to 100 mm =best imaginable health state; higher scores indicate a better health state.
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Timepoint [8]
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Part 2 Baseline, Week 12, 2 to 6 weeks after last dose
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Secondary outcome [9]
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Maximum Observed Plasma Concentration (Cmax)
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Assessment method [9]
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Timepoint [9]
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0 hour (pre-dose) on Day 1, 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 29
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Secondary outcome [10]
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Time to Reach Maximum Observed Plasma Concentration (Tmax)
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Assessment method [10]
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Timepoint [10]
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0 hour (pre-dose) on Day 1, 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 29
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Secondary outcome [11]
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Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)]
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Assessment method [11]
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AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24).
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Timepoint [11]
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0 hour (pre-dose) on Day 1, 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 29
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Eligibility
Key inclusion criteria
- Woman aged 18 years or older.
- Confirmed pathologic diagnosis of breast cancer.
- Locally advanced, metastatic, or locoregional recurrent breast cancer not amenable to
curative treatment with surgery or radiotherapy.
- Surgically sterile or postmenopausal woman.
- Documented ER+ and/or PgR+ and erbB2- tumor.
- Progression of locally advanced or metastatic disease during treatment with a
nonsteroidal AI or tamoxifen, or progression during treatment with (or within 6 months
of discontinuation of) an adjuvant nonsteroidal AI.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Prior exemestane, prior bosutinib, or any other prior anti-Src therapy.
- More than 1 prior endocrine treatment for locally advanced or MBC.
- More than 1 prior cytotoxic chemotherapy regimen in metastatic setting.
- Bone or skin as the only site of disease.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/06/2010
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Sample size
Target
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Accrual to date
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Final
42
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Pfizer Investigational Site - South Brisbane
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Recruitment postcode(s) [1]
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4101 - South Brisbane
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Florida
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Country [2]
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United States of America
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State/province [2]
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Illinois
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Country [3]
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United States of America
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State/province [3]
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Massachusetts
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Country [4]
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United States of America
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State/province [4]
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Michigan
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Country [5]
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United States of America
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State/province [5]
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New Jersey
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Country [6]
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United States of America
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State/province [6]
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New York
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Country [7]
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United States of America
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State/province [7]
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Pennsylvania
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Country [8]
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United States of America
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State/province [8]
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Washington
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Country [9]
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Belgium
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State/province [9]
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Brussels
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Country [10]
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Belgium
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State/province [10]
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Leuven
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Country [11]
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Belgium
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State/province [11]
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Liege
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Belgium
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State/province [12]
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Wilrijk
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Country [13]
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Canada
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State/province [13]
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British Columbia
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Country [14]
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China
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State/province [14]
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Beijing
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Country [15]
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Hong Kong
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State/province [15]
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Hong Kong
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Country [16]
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Hungary
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State/province [16]
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Budapest
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Country [17]
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India
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State/province [17]
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Maharashtra
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Country [18]
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Poland
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State/province [18]
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Olsztyn
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Country [19]
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South Africa
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State/province [19]
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Gauteng
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Country [20]
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Spain
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State/province [20]
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Barcelona
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Country [21]
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Spain
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State/province [21]
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Madrid
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Country [22]
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Spain
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State/province [22]
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Valencia
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Country [23]
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State/province [23]
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pfizer
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a phase 2, open-label, multicenter, 2-arm study of bosutinib administered in
combination with exemestane versus exemestane alone. This is a 2-part study consisting of a
safety lead-in phase and randomized phase 2 portion. Subjects in part 1 will receive
bosutinib and exemestane daily, and will be closely monitored for 28 days. If no safety
concerns arise, then future eligible subjects will be randomly assigned to the main phase of
the study. They will either receive bosutinib daily combined with daily exemestane, or daily
exemestane alone for a specified period of time. Subjects will be followed up for survival
after treatment discontinuation.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00793546
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Pfizer CT.gov Call Center
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Address
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Pfizer
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00793546
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