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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01945775




Registration number
NCT01945775
Ethics application status
Date submitted
11/09/2013
Date registered
19/09/2013

Titles & IDs
Public title
A Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (EMBRACA Study)
Scientific title
A PHASE 3, OPEN-LABEL, RANDOMIZED PARALLEL,2-ARM,MULTI-CENTER STUDY OF TALAZOPARIB(BMN 673) VERSUS PHYSICIAN'S CHOICE IN GERMLINE BRCA MUTATION SUBJECTS WITH LOCALLY ADVANCED AND/OR METASTATIC BREAST CANCER, WHO HAVE RECEIVED PRIOR CHEMOTHERAPY REGIMENS FOR METASTATIC DISEASE
Secondary ID [1] 0 0
C3441009
Secondary ID [2] 0 0
673-301
Universal Trial Number (UTN)
Trial acronym
EMBRACA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Neoplasms 0 0
BRCA 1 Gene Mutation 0 0
BRCA 2 Gene Mutation 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - talazoparib
Treatment: Drugs - Physician's-Choice

Experimental: talazoparib - Patient will be randomized 2:1 to receive talazoparib oral capsules (1.0 mg) once daily for 21 continuous days

Active comparator: Physician's-Choice - Capecitabine, Eribulin, Gemcitabine or Vinorelbine


Treatment: Drugs: talazoparib
Until progression or unacceptable toxicity develops

Treatment: Drugs: Physician's-Choice
Capecitabine, Eribulin, Gemcitabine or Vinorelbine
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS): Independent Radiological Facility (IRF) Assessment
Timepoint [1] 0 0
Baseline until radiologic progressive disease or death due to any cause (up to maximum duration of 36.9 months)
Secondary outcome [1] 0 0
Percentage of Participants With Objective Response: Investigator Assessment
Timepoint [1] 0 0
Baseline until radiologic progressive disease or death due to any cause (up to a maximum duration of 36.9 months)
Secondary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
Baseline until death due to any cause or analysis cut-off, up to a maximum duration of 61.4 months
Secondary outcome [3] 0 0
Trough Plasma Talazoparib Concentrations
Timepoint [3] 0 0
Predose on Day 1 of Cycle 2, 3 and 4
Secondary outcome [4] 0 0
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Timepoint [4] 0 0
Talazoparib: Baseline up to a maximum duration of 71.3 months; Physician's Choice Treatment: Baseline up to maximum duration of 46.1 months
Secondary outcome [5] 0 0
Number of Participants With Grade 3 or 4 Post-baseline Toxicities in Laboratory Parameters: Hematology
Timepoint [5] 0 0
Talazoparib: Baseline up to a maximum duration of 71.3 months; Physician's Choice Treatment: Baseline up to maximum duration of 46.1 months.
Secondary outcome [6] 0 0
Number of Participants With Grade 3 or 4 Post-baseline Toxicities in Laboratory Parameters: Chemistry
Timepoint [6] 0 0
Talazoparib: Baseline up to a maximum duration of 71.3 months; Physician's Choice Treatment: Baseline up to maximum duration of 46.1 months
Secondary outcome [7] 0 0
Number of Participants With Potentially Clinically Significant Changes From Baseline in Vital Signs
Timepoint [7] 0 0
Talazoparib: Baseline up to a maximum duration of 71.3 months; Physician's Choice Treatment: Baseline up to maximum duration of 46.1 months
Secondary outcome [8] 0 0
Number of Participants Taking At-least One Concomitant Medication
Timepoint [8] 0 0
Talazoparib: Baseline up to a maximum duration of 71.3 months; Physician's Choice Treatment: Baseline up to maximum duration of 46.1 months

Eligibility
Key inclusion criteria
* Histologically or cytologically confirmed carcinoma of the breast
* Locally advanced breast cancer that is not amenable to curative radiation or surgical cure and/or metastatic disease appropriate for systemic single cytotoxic chemotherapy
* Documentation of a deleterious, suspected deleterious, or pathogenic germline BRCA1 or BRCA2 mutation from Myriad Genetics or other laboratory approved by the Sponsor
* No more than 3 prior chemotherapy-inclusive regimens for locally advanced and/or metastatic disease (no limit on prior hormonal therapies or targeted anticancer therapies such as mechanistic target of rapamycin (mTOR) or CDK4/6 inhibitors, immune-oncology agents, tyrosine kinase inhibitors, or monoclonal antibodies against CTL4 or VEGF)
* Prior treatment with a taxane and/or anthracycline in the neoadjuvant, adjuvant, locally advanced, or metastatic setting unless medically contraindicated
* Have measurable or non-measurable, evaluable disease by the revised response evaluation criteria in solid tumors (RECIST) v.1.1
* Eastern Cooperative Oncology Group (ECOG) performance status = 2
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* First-line locally advanced and/or metastatic breast cancer with no prior adjuvant chemotherapy unless the Investigator determines that one of the 4 cytotoxic chemotherapy agents in the control arm would otherwise be offered to the subject
* Prior treatment with a PARP inhibitor (not including iniparib)
* Not a candidate for treatment with at least 1 of the treatments of protocol-specific physician's choice (ie, capecitabine, eribulin, gemcitabine, vinorelbine)
* Subjects who had objective disease progression while receiving platinum chemotherapy administered for locally advanced or metastatic disease; subjects who received low-dose platinum therapy administered in combination with radiation therapy are not excluded
* Subjects who have received platinum in the adjuvant or neoadjuvant setting are eligible; however, subjects may not have relapsed within 6 months of the last dose of prior platinum therapy
* Cytotoxic chemotherapy within 14 days before randomization
* Radiation or anti-hormonal therapy or other targeted anticancer therapy within 14 days before randomization
* HER2 positive breast cancer
* Active inflammatory breast cancer
* CNS metastases

* Exception: Adequately treated brain metastases documented by baseline CT or MRI scan that has not progressed since previous scans and that does not require corticosteroids (except prednisone = 5 mg/day or equivalent) for management of CNS symptoms. A repeat CT or MRI following the identification of CNS metastases (obtained at least 2 weeks after definitive therapy) must document adequately treated brain metastases.
* Subjects with leptomeningeal carcinomatosis are not permitted
* Prior malignancy except for any of the following:

* Prior BRCA-associated cancer as long as there is no current evidence of the cancer
* Carcinoma in situ or non-melanoma skin cancer
* A cancer diagnosed and definitively treated = 5 years before randomization with no subsequent evidence of recurrence
* Known to be human immunodeficiency virus positive
* Known active hepatitis C virus, or known active hepatitis B virus
* Known hypersensitivity to any of the components of talazoparib

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/10/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/03/2021
Sample size
Target
Accrual to date
Final
431
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
ICON Cancer Care (Haematology And Oncology Clinics Of Australasia (Hoca))-Milton - Milton
Recruitment hospital [3] 0 0
Icon Cancer Care, Corporate Office - South Brisbane
Recruitment hospital [4] 0 0
ICON Cancer Care - South Brisbane
Recruitment hospital [5] 0 0
ICON Cancer Foundation - South Brisbane
Recruitment hospital [6] 0 0
Mater Adult Hospital - South Brisbane
Recruitment hospital [7] 0 0
Icon Cancer Care South Brisbane - South Brisbane
Recruitment hospital [8] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [9] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [10] 0 0
Adelaide Cancer Centre - Kurralta Park
Recruitment hospital [11] 0 0
Ashford Cancer Centre Research - Kurralta Park
Recruitment hospital [12] 0 0
Cancer Care SA PTY Ltd - Kurralta Park
Recruitment hospital [13] 0 0
Cancer Care SA trading as Icon Pharmacy Adelaide - Kurralta Park
Recruitment hospital [14] 0 0
Victoria Breast and Oncology Care - East Melbourne
Recruitment hospital [15] 0 0
Peninsula & South Eastern Haematology and Oncology Group - Frankston
Recruitment hospital [16] 0 0
Barwon Health, University Hospital Geelong - Geelong
Recruitment hospital [17] 0 0
Austin Health, Heidelberg Repatriation Hospital (radiology (MUGA)scans only) - Heidelberg West
Recruitment hospital [18] 0 0
Austin Health, The Austin Hospital - Melbourne
Recruitment hospital [19] 0 0
Slade Pharmacy Mount Waverley - Mount Waverley
Recruitment hospital [20] 0 0
Nova Pharmacy - Wendouree
Recruitment hospital [21] 0 0
Ballarat Oncology & Haematology Services Clinical Trials Unit - Wendouree
Recruitment hospital [22] 0 0
Ballarat Oncology & Haematology Services - Wendouree
Recruitment hospital [23] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [24] 0 0
Sir Charles Gairdner Hospital Lung Institute Of Western Australia - Nedlands
Recruitment hospital [25] 0 0
River City Pharmacy - Auchenflower
Recruitment hospital [26] 0 0
Icon Cancer Care - Milton
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
4064 - Milton
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
Recruitment postcode(s) [4] 0 0
4104 - South Brisbane
Recruitment postcode(s) [5] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [6] 0 0
5042 - Bedford Park
Recruitment postcode(s) [7] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [8] 0 0
3002 - East Melbourne
Recruitment postcode(s) [9] 0 0
3199 - Frankston
Recruitment postcode(s) [10] 0 0
3220 - Geelong
Recruitment postcode(s) [11] 0 0
3081 - Heidelberg West
Recruitment postcode(s) [12] 0 0
3084 - Melbourne
Recruitment postcode(s) [13] 0 0
3149 - Mount Waverley
Recruitment postcode(s) [14] 0 0
3353 - Wendouree
Recruitment postcode(s) [15] 0 0
3355 - Wendouree
Recruitment postcode(s) [16] 0 0
6150 - Murdoch
Recruitment postcode(s) [17] 0 0
6009 - Nedlands
Recruitment postcode(s) [18] 0 0
4066 - Auchenflower
Recruitment postcode(s) [19] 0 0
4066 - Milton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
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California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Minnesota
Country [12] 0 0
United States of America
State/province [12] 0 0
Mississippi
Country [13] 0 0
United States of America
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Missouri
Country [14] 0 0
United States of America
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Nevada
Country [15] 0 0
United States of America
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New York
Country [16] 0 0
United States of America
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North Carolina
Country [17] 0 0
United States of America
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Oklahoma
Country [18] 0 0
United States of America
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Oregon
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United States of America
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Pennsylvania
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Virginia
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United States of America
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Washington
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Belgium
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Gent
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Belgium
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Liege
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Brazil
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RJ
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Brazil
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RS
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Brazil
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SP
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France
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Besancon
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France
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LYON cedex 08
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France
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Marseille
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France
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Nantes BP 20215
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France
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Paris
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France
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Saint Herblain
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France
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Strasbourg
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France
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Toulouse
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France
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Tours Cedex 9
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France
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Villejuif Cedex
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Germany
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Bavaria
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Germany
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Saxony
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Germany
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Berlin
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Germany
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Duesseldorf
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Germany
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Erlangen
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Germany
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Essen
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Germany
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Freiburg
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Germany
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Leer
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Germany
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Munich
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Germany
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Rostock
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Germany
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Ulm
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Ireland
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Dublin 4
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Ireland
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Dublin 7
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Galway
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Beer Sheva
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Israel
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Haifa
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Israel
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Petach Tikva
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Israel
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Tel Aviv
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Israel
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Tel Hashomer
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Israel
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Tel-Aviv
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Israel
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Zerifin
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Italy
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AV
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Italy
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MI
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Italy
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Monza AND Brianza
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Italy
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Monza Brianza
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Italy
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PA
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Italy
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PI
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Italy
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RM
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Italy
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VR
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Italy
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Bologna
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Italy
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Milano
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Italy
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Roma
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Korea, Republic of
State/province [71] 0 0
Gyeonggi-do
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Korea, Republic of
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Daegu
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seoul
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Korea, Republic of
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Ulsan
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Poland
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LODZ Province
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Poland
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Dobra
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Gdansk
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Gliwice
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Katowice
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Otwock
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Poznan
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Poland
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Szczecin
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Poland
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Warszawa
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Russian Federation
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Leningrad Region
Country [86] 0 0
Russian Federation
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Petrozavodsk
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Russian Federation
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St. Petersburg
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Spain
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Avila
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Spain
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Badalona Barcelona
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Spain
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Barcelona
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Spain
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Castellon
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Spain
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Jaen
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Spain
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La Coruna
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Spain
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La Laguna Santa Cruz De Tenerife
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Spain
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Lleida
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Spain
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Madrid
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Spain
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Pozuelo De Alarcon (Madrid)
Country [98] 0 0
Spain
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Sabadell Barcelona
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Spain
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Sevilla
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Taiwan
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Changhua
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Taiwan
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Taipei
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Ukraine
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Kriviy Rig
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Ukraine
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Sumy
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United Kingdom
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England
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United Kingdom
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Nottinghamshire
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United Kingdom
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Brighton
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United Kingdom
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Leeds
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United Kingdom
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London
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United Kingdom
State/province [109] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Medivation, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01945775