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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05382299
Registration number
NCT05382299
Ethics application status
Date submitted
16/05/2022
Date registered
19/05/2022
Titles & IDs
Public title
Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Patients With Previously Untreated Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer
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Scientific title
A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Do Not Express PD-L1 or in Patients Previously Treated With Anti-PD-(L)1 Agents in the Early Setting Whose Tumors Do Express PD-L1
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Secondary ID [1]
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2021-005743-79
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Secondary ID [2]
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GS-US-592-6238
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Universal Trial Number (UTN)
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Trial acronym
ASCENT-03
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Triple Negative Breast Cancer
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PD-L1 Negative
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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 - Sacituzumab Govitecan-hziy
Treatment: Drugs - Paclitaxel
Treatment: Drugs - nab-Paclitaxel
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Carboplatin
Experimental: Sacituzumab Govitecan-hziy (SG) - Participants will receive SG 10 mg/kg on Days 1 and 8 of a 21-day cycle.
Active comparator: Treatment of Physician's Choice (TPC) - Participants will receive TPC determined prior to randomization from 1 of the 3 allowed regimens:
* Paclitaxel 90 mg/m\^2 on Days 1, 8, and 15 of a 28-day cycle
* Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of a 28-day cycle
* Gemcitabine 1000 mg/m\^2 + carboplatin area under the curve (AUC) 2 on Days 1 and 8 of a 21-day cycle
Treatment: Drugs: Sacituzumab Govitecan-hziy
Administered intravenously
Treatment: Drugs: Paclitaxel
Administered intravenously
Treatment: Drugs: nab-Paclitaxel
Administered intravenously
Treatment: Drugs: Gemcitabine
Administered intravenously
Treatment: Drugs: Carboplatin
Administered intravenously
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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) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
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Assessment method [1]
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PFS is defined as the time from the date of randomization until the date of objective progressive disease (PD), or death (whichever comes first).
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Timepoint [1]
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Randomization up to approximately 22 months
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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OS is defined as the time from the date of randomization until death due to any cause.
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Timepoint [1]
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Randomization up to approximately 57 months
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Secondary outcome [2]
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Objective Response Rate (ORR) as Assessed by BICR per RECIST Version 1.1
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Assessment method [2]
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ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks after initial documentation of response.
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Timepoint [2]
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Randomization up to approximately 57 months
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Secondary outcome [3]
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Duration of Response (DOR) as Assessed by BICR per RECIST Version 1.1
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Assessment method [3]
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DOR is defined as the time from the first documentation of CR or PR to the earlier of the first documentation of definitive PD or death from any cause (whichever comes first).
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Timepoint [3]
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Randomization up to approximately 57 months
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Secondary outcome [4]
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Time to Response (TTR) as Assessed by BICR per RECIST Version 1.1
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Assessment method [4]
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TTR is defined as the time from the date of randomization until the first documentation of CR or PR.
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Timepoint [4]
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Randomization up to approximately 57 months
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Secondary outcome [5]
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Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
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Assessment method [5]
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Timepoint [5]
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First dose date up to approximately 57 months plus 30 days
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Secondary outcome [6]
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Percentage of Participants Experiencing Clinical Laboratory Abnormalities
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Assessment method [6]
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Timepoint [6]
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First dose date up to approximately 57 months plus 30 days
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Secondary outcome [7]
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Change from Baseline in the Physical Functioning Domain as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Core Questionnaire, Version 3.0 (EORTC QLQ-C30).
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Assessment method [7]
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The EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer patients, it is composed of 30 questions (items) to assess 15 scales; 1 global health status/quality of life (QOL), 5 functional scales (physical, role, cognitive, emotional, and social), and 9 symptom/item scales(fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high/healthy level of function, a high score for the global health status/QOL represents a high QOL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
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Timepoint [7]
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Randomization up to approximately 57 months
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Secondary outcome [8]
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Time to Deterioration (TTD) of Fatigue Scale of the EORTC QLQ-C30
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Assessment method [8]
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TTD is defined as the time between the date of randomization and the date of assessment at which a patient experienced a deterioration (= 10 points deterioration from baseline in the fatigue scale) or death.
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Timepoint [8]
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Randomization up to approximately 57 months
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Eligibility
Key inclusion criteria
Key
* Individuals, regardless of race and ethnic group, with previously untreated locally advanced, inoperable or metastatic triple-negative breast cancer (TNBC)
* Individuals whose tumors are programmed cell death ligand 1 (PD-L1) negative at screening or individuals whose tumors are PD-L1 positive at screening if they have received an anti-PD-(L)1 inhibitor in the (neo) adjuvant setting or if they cannot be treated with a checkpoint inhibitor due to a comorbidity
* Centrally confirmed TNBC and PD-L1 status on fresh or archival tissue
* Individuals must have completed treatment for Stage I-III breast cancer, if indicated, and = 6 months must have elapsed (with the exception of endocrine therapy) between completion of treatment with curative intent and first documented local or distant disease recurrence
* Individuals presenting with de novo metastatic TNBC are eligible
* Measurable disease based on computed tomography (CT) or magnetic resonance imaging (MRI) in accordance with per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. as evaluated locally
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Demonstrates adequate organ function
* Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception
* Individuals with human immunodeficiency virus (HIV) must be on antiretroviral therapy (ART) and have a well-controlled HIV infection/disease
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Positive serum pregnancy test or women who are lactating
* Received systemic anticancer treatment within the previous 6 months or radiation therapy within 2 weeks prior to enrollment
* Have not recovered from adverse events (AEs) due to a previously administered agent at the time study entry
* May not be participating in a study with an investigational agent or investigational device within 4 weeks prior to randomization. Individuals participating in observational studies are eligible
* Previously received topoisomerase 1 inhibitors or antibody drug conjugates containing a topoisomerase inhibitor
* Active second malignancy
* Active serious infection requiring antibiotics
* Positive for HIV-1 or 2 with a history of Kaposi sarcoma and/or Multicentric Castleman Disease
* Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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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 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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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
20/07/2022
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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
1/05/2027
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Actual
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Sample size
Target
540
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
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Recruitment hospital [1]
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Border Medical Oncology - Albury
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Saint George Hospital - Australia - Kogarah
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Mater Hospital - North Sydney - North Sydney
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GenesisCare - North Shore - St Leonards
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Mater Misericordiae Limited and Mater Research Limited - South Brisbane
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Princess Alexandra Hospital - Woolloongabba
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Cancer Research SA (CRSA) - Adelaide
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Icon Cancer Centre Hobart - Hobart
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Monash Medical Centre - Clayton
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Austin Hospital - Melbourne
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Breast Cancer Research Center - Western Australia - Nedlands
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2640 - Albury
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2217 - Kogarah
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2060 - North Sydney
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2065 - St Leonards
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4101 - South Brisbane
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4102 - Woolloongabba
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5000 - Adelaide
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7000 - Hobart
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3168 - Clayton
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3084 - Melbourne
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Recruitment postcode(s) [11]
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6009 - Nedlands
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Nantes
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Country [101]
0
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France
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State/province [101]
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Pierre-benite
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Country [102]
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France
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Plerin
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Country [103]
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France
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Rennes Cedex
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France
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Toulouse
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Country [105]
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France
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Villejuif
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Country [106]
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Germany
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Berlin
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Germany
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Bonn
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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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Hamburg
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Germany
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Heidelberg
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Germany
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Köln
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Germany
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Lübeck
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Germany
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Mannheim
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Germany
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Munster
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Germany
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Mönchengladbach
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Germany
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München
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Germany
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Tübingen
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Germany
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Wiesbaden
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0
Hong Kong
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Hong Kong
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0
Hong Kong
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New Territories
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Hong Kong
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Pok Fu Lam
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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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Israel
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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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Jerusalem
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Israel
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Kfar Saba
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Israel
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Petah Tikva
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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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Bari
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Italy
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Bologna
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Italy
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Brescia
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Italy
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Genova GE
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Italy
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Lecco
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Italy
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Lucca
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Italy
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Macerata
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Italy
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Milano
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Italy
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Milan
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Italy
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Monza
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Italy
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Napoli
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Italy
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Novara
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Italy
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Padova
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Italy
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Prato
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Italy
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Roma
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Italy
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Rome
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Italy
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Siena
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Japan
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Aichi
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Japan
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Aoba-ku
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Japan
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Bunkyo-ku
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Japan
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Chuo-ku
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Japan
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Ehime
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Japan
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Fukushima
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Japan
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State/province [157]
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Inamachi
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Japan
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State/province [158]
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Kagoshima-shi
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Country [159]
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Japan
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State/province [159]
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Kanagawa
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Japan
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State/province [160]
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Kashiwa
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Japan
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Koto-ku
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Japan
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Kumamoto- shi
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Japan
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State/province [163]
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Kure
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0
Japan
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State/province [164]
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Mie
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0
Japan
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Minami-ku
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Japan
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Nagoya
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Japan
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State/province [167]
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Naka-ku
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Japan
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State/province [168]
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Niigata-shi
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Japan
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Okayama
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0
Japan
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Ota
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Japan
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Sakyo-ku
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Japan
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Sapporo
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Japan
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Shizuoka-city
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Japan
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Shizuoka
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Japan
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State/province [175]
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Suita
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0
Japan
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Tokyo
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0
Japan
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Yokohama
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Korea, Republic of
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Goyang-si Gyeonggi-do
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Korea, Republic of
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Seongnam-si
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Korea, Republic of
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Seoul
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Malaysia
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Georgetown
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Malaysia
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Johor Bahru
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Malaysia
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Kuala Lumpur
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Malaysia
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Putrajaya
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Malaysia
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Sabah
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Malaysia
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Sarawak
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Mexico
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Chihuahua
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Mexico
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Ciudad de Mexico
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Mexico
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Culiacan
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Mexico
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Guadalajara
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Mexico
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Merida
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Mexico
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Monterrey
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Mexico
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México
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Mexico
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San Luis Potosi
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Mexico
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Veracruz
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Mexico
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Zapopan
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Netherlands
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Breda
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Netherlands
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Groningen
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Netherlands
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Leeuwarden
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Netherlands
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Maastricht
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Netherlands
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Rotterdam
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Poland
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Gdansk
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Poland
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Gliwice
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Poland
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Opole
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Poland
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Poznan
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Poland
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Siedlce
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Poland
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Warsaw
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Poland
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Warszawa
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Puerto Rico
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Ponce
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Puerto Rico
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San Juan
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Country [211]
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Romania
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Bucharest
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Country [212]
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Romania
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Cluj-Napoca
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Romania
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Craiova
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Romania
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Timisoara
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Singapore
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Singapore
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Country [216]
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0
Slovakia
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Bratislava
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Slovakia
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Košice
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Slovakia
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Partizánske
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South Africa
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Hilton
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South Africa
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Johannesburg
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South Africa
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Pretoria
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Spain
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A Coruña
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Spain
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Barcelona
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Spain
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Bilbo
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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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Malaga
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Spain
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Murcia
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Spain
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Sevilla
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Spain
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Tenerife
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Spain
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Valencia
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Country [232]
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Switzerland
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Baden
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Switzerland
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Liestal
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Switzerland
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St. Gallen
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Switzerland
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Winterthur
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Switzerland
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Zürich
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Taiwan
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Changhua
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Taiwan
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Hualien City
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Taiwan
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Kaohsiung City
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Taiwan
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New Taipei City
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0
0
Taiwan
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Taichung
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0
0
Taiwan
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Tainan City
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0
Taiwan
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Taipei
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0
Taiwan
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Taoyuan City
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Turkey
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Adana
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Country [246]
0
0
Turkey
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Ankara
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0
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Turkey
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Edirne
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Turkey
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Istanbul
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Turkey
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Izmir
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Turkey
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Sariyer
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0
Turkey
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0
Sisli
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Country [252]
0
0
United Kingdom
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0
0
Cheltenham
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Country [253]
0
0
United Kingdom
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0
0
Glasgow
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Country [254]
0
0
United Kingdom
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0
0
Leeds
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Country [255]
0
0
United Kingdom
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State/province [255]
0
0
London
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Gilead Sciences
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Address
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Country
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Ethics approval
Ethics application status
Query!
Summary
Brief summary
The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) versus treatment of physician's choice (TPC) in participants with previously untreated, locally advanced, inoperable or metastatic triple-negative breast cancer whose tumors do not express programmed cell death ligand 1 (PD-L1) or in participants previously treated with anti-programmed cell death (ligand or protein) 1 (Anti-PD-(L)1) Agents in the early setting whose tumors do express PD-L1.
Query!
Trial website
https://clinicaltrials.gov/study/NCT05382299
Query!
Trial related presentations / publications
Query!
Public notes
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Contacts
Principal investigator
Name
0
0
Gilead Study Director
Query!
Address
0
0
Gilead Sciences
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Gilead Clinical Study Information Center
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
1-833-445-3230 (GILEAD-0)
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Query!
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 not provided in
https://clinicaltrials.gov/study/NCT05382299