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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01160211




Registration number
NCT01160211
Ethics application status
Date submitted
1/07/2010
Date registered
12/07/2010

Titles & IDs
Public title
A Study to Compare the Safety and Efficacy of an Aromatase Inhibitor in Combination With Lapatinib, Trastuzumab or Both for the Treatment of Hormone Receptor Positive, HER2+ Metastatic Breast Cancer
Scientific title
A Phase III Trial to Compare the Safety and Efficacy of Lapatinib Plus Trastuzumab Plus an Aromatase Inhibitor (AI) vs. Trastuzumab Plus an AI vs. Lapatinib Plus an AI as 1st- or 2nd- Line Therapy in Postmenopausal Subjects With Hormone Receptor+, HER2-positive Metastatic Breast Cancer (MBC) Who Received Prior Trastuzumab and Endocrine Therapies
Secondary ID [1] 0 0
2010-019577-16
Secondary ID [2] 0 0
114299
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neoplasms, Breast 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - lapatinib
Treatment: Drugs - trastuzumab
Treatment: Drugs - Aromatase inhibitor
Treatment: Drugs - lapatinib

Experimental: Lapatinib plus trastuzumab plus aromatase inhibitor - Experimental

Active comparator: trastuzmab plus aromatase inhibitor - Active Comparator

Active comparator: lapatinib plus aromatase inhibitor - Active Comparator


Treatment: Drugs: lapatinib
1000 mg by mouth once a day

Treatment: Drugs: trastuzumab
Loading dose of 8 mg/kg IV followed by the maintenance dose of 6 mg/kg IV every 3 weeks

Treatment: Drugs: Aromatase inhibitor
Aromatase inhibitor (either letrozole, anastrozole, or exemestane) of investigator's choice given by mouth once daily

Treatment: Drugs: lapatinib
1500 mg by mouth once daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
PFS of Lapatinib+Trastuzumab+AI Combination vs. Trastuzumab+AI Combination
Timepoint [1] 0 0
approximately 5 years
Primary outcome [2] 0 0
Median Kaplan Meier Estimates for PFS of Lapatinib+Trastuzumab+AI Combination vs. Trastuzumab+AI Combination
Timepoint [2] 0 0
approximately 5 years
Secondary outcome [1] 0 0
PFS of Trastuzumab/AI vs. Lapatinib/AI and Trastuzumab/Lapatinib/AI vs. Lapatinib/AI
Timepoint [1] 0 0
approximately 5 years
Secondary outcome [2] 0 0
Overall Survival (OS) Events of Lapatinib+Trastuzumab+AI vs. Trastuzumab+AI and Lapatinib+AI vs. Trastuzumab+AI
Timepoint [2] 0 0
approximately 5 years
Secondary outcome [3] 0 0
Overall Response Rate (ORR; Complete or Partial Response) in Lapatinib+Trastuzumab+AI vs. Trastuzumab+AI and Lapatinib+AI vs. Trastuzumab+AI
Timepoint [3] 0 0
approximately 5 years
Secondary outcome [4] 0 0
Clinical Benefit Rate (CBR; Complete Response, Partial Response, or Stable Disease for at Least 6 Months) in Lapatinib+Trastuzumab+AI vs. Trastuzumab+AI and Lapatinib+AI vs. Trastuzumab+AI
Timepoint [4] 0 0
approximately 5 years
Secondary outcome [5] 0 0
Duration of Response in Lapatinib+Trastuzumab+AI vs. Trastuzumab+AI and Lapatinib+AI vs. Trastuzumab+AI
Timepoint [5] 0 0
approximately 5 years
Secondary outcome [6] 0 0
Changes in the Quality of Life (QoL) Status Relative to Baseline FACT-B Overall and Subscale Scores at Last On-treatment Assessment
Timepoint [6] 0 0
approximately 5 years
Secondary outcome [7] 0 0
Time to Response in Lapatinib+Trastuzumab+AI vs. Trastuzumab+AI and Lapatinib+AI vs. Trastuzumab+AI
Timepoint [7] 0 0
approximately 5 years

Eligibility
Key inclusion criteria
Inclusion Criteria

Subjects eligible for enrollment in the study must meet all of the following criteria:

1. Signed written informed consent. In Korea and Japan, subjects between >=18 and <20 years of age must also have a legal representative sign the written informed consent.
2. Post-menopausal female subjects >=18 years of age. Post-menopausal as defined by any of the following:

* Subjects at least 60 years of age.
* Subjects under 60 years of age and amenorrhic for at least 12 consecutive months AND follicle-stimulating hormone (FSH) and estradiol levels in postmenopausal range (utilizing ranges from the local laboratory facility).
* Prior bilateral oophorectomy.
* Prior radiation castration with amenorrhea for at least 6 months
3. Subjects must have a history of histologically confirmed breast cancer, with a clinically confirmed diagnosis of metastatic disease [confirmed by histology, cytology or other clinical means (e.g. CT, MRI)]. Subjects may have either measurable or non-measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
4. Tumors that are ER+ and/or PgR+ by local laboratory
5. Documentation of HER2 overexpression or gene amplification, in the invasive component of either the primary tumor or metastatic disease site as defined as:

* 3+ by Immunohistochemistry (IHC) and/or
* HER2/neu gene amplification by fluorescence, chromogenic or silver in situ hybridization [FISH, CISH or SISH; >6 HER2/neu gene copies per nucleus or a FISH, CISH or SISH test ratio (HER2 gene copies to chromosome 17 signals) of =2.0]
6. Subject must have received at least one prior regimen containing trastuzumab in combination with chemotherapy for breast cancer:.

* Subject has ONLY received prior trastuzumab in combination with chemotherapy as neoadjuvant and/or adjuvant treatment. OR
* Subject has received ONE prior trastuzumab-containing regimen for metastatic disease (and has progressed), and may or may not have received prior trastuzumab in combination with chemotherapy as neoadjuvant and/or adjuvant treatment.
7. Subject must have received prior endocrine therapy (such as aromatase inhibitors or selective estrogen receptor modulators). 8. Subjects who have a life expectancy of > 6 months as assessed by the treating investigator

9. Subjects must have baseline Left Ventricular Ejection Fraction (LVEF) =50% measured by echocardiography (ECHO) or multi-gated acquisition scan (MUGA) 10. Subject must have an ECOG performance status of 0-1 11. All prior treatment related toxicities must be CTCAE (Version 4.0) = Grade 1 at the time of randomization 12. Completion of screening assessments 13. Adequate baseline organ function. 14. Subjects must meet all of the following criteria:

* QTc <450msec or
* QTc <480msec for subjects with bundle branch block The QTc is the QT interval corrected for heart rate according to either Bazett's formula (QTcB) or to Fridericia's formula (QTcF), machine or manual over read, for males and females. The specific formula that will be used in a protocol should be determined prior to initiation of the study, and the formula used to determine inclusion and discontinuation should be the same throughout the study. The QTc should be based on single or averaged QTc values of triplicate electrocardiograms (ECGs) obtained over a brief recording period
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

1. History of another malignancy. Exception: Subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.
2. Subjects with extensive symptomatic visceral disease including hepatic involvement and pulmonary lymphangitic spread of tumor, or the disease is considered by the investigator to be rapidly progressing or life threatening (subjects who are intended for chemotherapy)
3. Serious cardiac illness or medical condition including but not confined to:

* Uncontrolled arrhythmias
* Uncontrolled or symptomatic angina
* History of congestive heart failure (CHF)
* Documented myocardial infarction <6 months from study entry
4. Known history of, or clinical evidence of, central nervous system (CNS) metastases or leptomeningeal carcinomatosis
5. Have acute or currently active/requiring anti-viral therapy hepatic or biliary disease (with the exception of subjects with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
6. Have a concurrent disease or condition that may interfere with study participation, or any serious medical disorder that would interfere with the subject's safety (for example, active or uncontrolled infection or any psychiatric condition prohibiting understanding or rendering of informed consent)
7. Have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels
8. Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to any of the study agents or their excipients that, in the opinion of the Investigator or GSK medical monitor, contraindicates their participation
9. Any prohibited medication.
10. Administration of an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of study treatment.

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
5/05/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/06/2022
Sample size
Target
Accrual to date
Final
369
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Box Hill
Recruitment hospital [2] 0 0
Novartis Investigative Site - Wodonga
Recruitment hospital [3] 0 0
Novartis Investigative Site - Adelaide
Recruitment hospital [4] 0 0
Novartis Investigative Site - Douglas
Recruitment hospital [5] 0 0
Novartis Investigative Site - Ringwood East
Recruitment hospital [6] 0 0
Novartis Investigative Site - Tweed Heads
Recruitment postcode(s) [1] 0 0
3128 - Box Hill
Recruitment postcode(s) [2] 0 0
3690 - Wodonga
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
4814 - Douglas
Recruitment postcode(s) [5] 0 0
3135 - Ringwood East
Recruitment postcode(s) [6] 0 0
2485 - Tweed Heads
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
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Indiana
Country [6] 0 0
United States of America
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Iowa
Country [7] 0 0
United States of America
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Michigan
Country [8] 0 0
United States of America
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Minnesota
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United States of America
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Montana
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United States of America
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Nebraska
Country [11] 0 0
United States of America
State/province [11] 0 0
New Mexico
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Tennessee
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Washington
Country [17] 0 0
United States of America
State/province [17] 0 0
Wisconsin
Country [18] 0 0
Argentina
State/province [18] 0 0
Buenos Aires
Country [19] 0 0
Argentina
State/province [19] 0 0
Río Negro
Country [20] 0 0
Argentina
State/province [20] 0 0
Santa Fe
Country [21] 0 0
Argentina
State/province [21] 0 0
Ciudad Autonoma de Buenos Aires
Country [22] 0 0
Argentina
State/province [22] 0 0
Cordoba
Country [23] 0 0
Argentina
State/province [23] 0 0
La Rioja
Country [24] 0 0
Argentina
State/province [24] 0 0
Quilmes
Country [25] 0 0
Argentina
State/province [25] 0 0
San Miguel de Tucuman
Country [26] 0 0
Belgium
State/province [26] 0 0
Leuven
Country [27] 0 0
Belgium
State/province [27] 0 0
Liege
Country [28] 0 0
Belgium
State/province [28] 0 0
Namur
Country [29] 0 0
Brazil
State/province [29] 0 0
Ceará
Country [30] 0 0
Brazil
State/province [30] 0 0
Goiás
Country [31] 0 0
Brazil
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Rio Grande Do Sul
Country [32] 0 0
Brazil
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São Paulo
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Brazil
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Rio de Janeiro
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Bulgaria
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Plovdiv
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Bulgaria
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Sofia
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Bulgaria
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Varna
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Canada
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Alberta
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China
State/province [38] 0 0
Fujian
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China
State/province [39] 0 0
Guangdong
Country [40] 0 0
China
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Jilin
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China
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Harbin
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China
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Shanghai
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Colombia
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Monteria
Country [44] 0 0
Croatia
State/province [44] 0 0
Osijek
Country [45] 0 0
Croatia
State/province [45] 0 0
Pula
Country [46] 0 0
Croatia
State/province [46] 0 0
Zagreb
Country [47] 0 0
France
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Besancon
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France
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Le Mans
Country [49] 0 0
France
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Lille
Country [50] 0 0
France
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Montpellier Cedex 5
Country [51] 0 0
France
State/province [51] 0 0
Nancy
Country [52] 0 0
France
State/province [52] 0 0
Paris Cedex 20
Country [53] 0 0
Germany
State/province [53] 0 0
Baden-Wuerttemberg
Country [54] 0 0
Germany
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Bayern
Country [55] 0 0
Germany
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Brandenburg
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Germany
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Mecklenburg-Vorpommern
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Germany
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Niedersachsen
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Germany
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Nordrhein-Westfalen
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Germany
State/province [59] 0 0
Sachsen-Anhalt
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Germany
State/province [60] 0 0
Schleswig-Holstein
Country [61] 0 0
Germany
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Berlin
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Germany
State/province [62] 0 0
Hamburg
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Greece
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Athens
Country [64] 0 0
Greece
State/province [64] 0 0
Chania
Country [65] 0 0
Greece
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Heraklion
Country [66] 0 0
Greece
State/province [66] 0 0
Perioxi Dragana, Alexandroupolis
Country [67] 0 0
Hong Kong
State/province [67] 0 0
Hong Kong
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Hong Kong
State/province [68] 0 0
Kowloon
Country [69] 0 0
Hong Kong
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Pokfulam
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Hong Kong
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Tuen Mun
Country [71] 0 0
Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Gyor
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Hungary
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Gyula
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Hungary
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Kaposvar
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Hungary
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Miskolc
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Hungary
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Nyiregyhaza
Country [78] 0 0
Hungary
State/province [78] 0 0
Pecs
Country [79] 0 0
Hungary
State/province [79] 0 0
Szeged
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Hungary
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Szolnok
Country [81] 0 0
Hungary
State/province [81] 0 0
Veszprem
Country [82] 0 0
Hungary
State/province [82] 0 0
Zalaegerszeg
Country [83] 0 0
India
State/province [83] 0 0
Bangalore
Country [84] 0 0
India
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Chennai
Country [85] 0 0
India
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Delhi
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India
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Nagpur
Country [87] 0 0
India
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New Delhi
Country [88] 0 0
India
State/province [88] 0 0
Pune
Country [89] 0 0
India
State/province [89] 0 0
Surat
Country [90] 0 0
Ireland
State/province [90] 0 0
Dublin 7
Country [91] 0 0
Ireland
State/province [91] 0 0
Dublin
Country [92] 0 0
Ireland
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Galway
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Petah-Tikva
Country [96] 0 0
Israel
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Ramat Gan
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Israel
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Rehovot
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Israel
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Tel Aviv
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Italy
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Emilia-Romagna
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Italy
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Lombardia
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Italy
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San Giovanni Rotondo
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Japan
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Aichi
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Japan
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Chiba
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Japan
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Ehime
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Japan
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Kagoshima
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Japan
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Osaka
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Japan
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Saitama
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Japan
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Shizuoka
Country [109] 0 0
Japan
State/province [109] 0 0
Tokyo
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Korea, Republic of
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Gyeonggi-do
Country [111] 0 0
Korea, Republic of
State/province [111] 0 0
Seoul
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Lithuania
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Vilnius
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Norway
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Lorenskog
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Peru
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Lima
Country [115] 0 0
Peru
State/province [115] 0 0
Arequipa
Country [116] 0 0
Peru
State/province [116] 0 0
Trujillo
Country [117] 0 0
Philippines
State/province [117] 0 0
Makati City
Country [118] 0 0
Philippines
State/province [118] 0 0
Quezon City
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Poland
State/province [119] 0 0
Konin
Country [120] 0 0
Poland
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Lubin
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Poland
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Otwock
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Poland
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Warszawa
Country [123] 0 0
Poland
State/province [123] 0 0
Wieliszew
Country [124] 0 0
Poland
State/province [124] 0 0
Wroclaw
Country [125] 0 0
Portugal
State/province [125] 0 0
Coimbra
Country [126] 0 0
Portugal
State/province [126] 0 0
Evora
Country [127] 0 0
Portugal
State/province [127] 0 0
Lisboa
Country [128] 0 0
Portugal
State/province [128] 0 0
Lisbon
Country [129] 0 0
Portugal
State/province [129] 0 0
Porto
Country [130] 0 0
Puerto Rico
State/province [130] 0 0
San Juan
Country [131] 0 0
Romania
State/province [131] 0 0
Bucharest
Country [132] 0 0
Romania
State/province [132] 0 0
Bucuresti
Country [133] 0 0
Romania
State/province [133] 0 0
Timisoara
Country [134] 0 0
Russian Federation
State/province [134] 0 0
Arkhangelsk
Country [135] 0 0
Russian Federation
State/province [135] 0 0
Kazan
Country [136] 0 0
Russian Federation
State/province [136] 0 0
Moscow
Country [137] 0 0
Russian Federation
State/province [137] 0 0
Ryazan
Country [138] 0 0
Russian Federation
State/province [138] 0 0
St. Petersburg
Country [139] 0 0
Russian Federation
State/province [139] 0 0
Tver
Country [140] 0 0
Serbia
State/province [140] 0 0
Belgrade
Country [141] 0 0
Serbia
State/province [141] 0 0
Kragujevac
Country [142] 0 0
Serbia
State/province [142] 0 0
Sremska Kamenica
Country [143] 0 0
Singapore
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Singapore
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South Africa
State/province [144] 0 0
Cape Town
Country [145] 0 0
South Africa
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Durban
Country [146] 0 0
South Africa
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Port Elizabeth
Country [147] 0 0
South Africa
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Pretoria
Country [148] 0 0
South Africa
State/province [148] 0 0
Saxonwold, Johannesburg
Country [149] 0 0
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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Cordoba
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Spain
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La Coruna
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Spain
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Madrid
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Spain
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Santa Cruz de Tenerife
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Taiwan
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Changhua
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Taiwan
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Kaohsiung Hsien
Country [157] 0 0
Taiwan
State/province [157] 0 0
Taipei City
Country [158] 0 0
Turkey
State/province [158] 0 0
Ankara
Country [159] 0 0
Turkey
State/province [159] 0 0
Izmir
Country [160] 0 0
Ukraine
State/province [160] 0 0
Chernivtsi
Country [161] 0 0
Ukraine
State/province [161] 0 0
Dnipropetrovsk
Country [162] 0 0
Ukraine
State/province [162] 0 0
Kharkiv
Country [163] 0 0
Ukraine
State/province [163] 0 0
Khmelnytskyi
Country [164] 0 0
Ukraine
State/province [164] 0 0
Lyutizh
Country [165] 0 0
Ukraine
State/province [165] 0 0
Sumy
Country [166] 0 0
Ukraine
State/province [166] 0 0
Uzhgorod
Country [167] 0 0
Ukraine
State/province [167] 0 0
Vinnitsia
Country [168] 0 0
United Kingdom
State/province [168] 0 0
Essex
Country [169] 0 0
United Kingdom
State/province [169] 0 0
West Midlands
Country [170] 0 0
United Kingdom
State/province [170] 0 0
Huddersfield
Country [171] 0 0
United Kingdom
State/province [171] 0 0
London
Country [172] 0 0
United Kingdom
State/province [172] 0 0
Maidstone
Country [173] 0 0
United Kingdom
State/province [173] 0 0
Manchester
Country [174] 0 0
United Kingdom
State/province [174] 0 0
Nottingham
Country [175] 0 0
United Kingdom
State/province [175] 0 0
Peterborough
Country [176] 0 0
United Kingdom
State/province [176] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
GlaxoSmithKline
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
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
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
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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?
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01160211