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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06926868
Registration number
NCT06926868
Ethics application status
Date submitted
8/04/2025
Date registered
15/04/2025
Date last updated
25/06/2025
Titles & IDs
Public title
A Study of Izalontamab Brengitecan Versus Chemotherapy in Participants With Previously Untreated, Locally Advanced, Recurrent Inoperable, or Metastatic Triple-negative Breast Cancer Ineligible for Anti-PD(L)1 Drugs (IZABRIGHT-Breast01)
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Scientific title
A Randomized, Open-label, Inferentially Seamless Phase 2/3 Study of Izalontamab Brengitecan (BMS-986507) Versus Treatment of Physician's Choice in Patients With Previously Untreated, Locally Advanced, Recurrent Inoperable,or Metastatic Triple-negative Breast Cancer (TNBC)or ER-low, HER2-negative BC Who Are Ineligible for Anti-PD1/PD-L1 Treatment
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Secondary ID [1]
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2024-519871-24
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Secondary ID [2]
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0
CA244-0008
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Neoplasms
0
0
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Condition category
Condition code
Cancer
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0
0
0
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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 - Iza-bren
Treatment: Drugs - Nab-paclitaxel
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Capecitabine
Treatment: Drugs - Carboplatin
Treatment: Drugs - Gemcitabine
Experimental: Arm A1 -
Experimental: Arm A2 -
Active comparator: Arm B -
Treatment: Drugs: Iza-bren
Specified dose on specified days
Treatment: Drugs: Nab-paclitaxel
Specified dose on specified days
Treatment: Drugs: Paclitaxel
Specified dose on specified days
Treatment: Drugs: Capecitabine
Specified dose on specified days
Treatment: Drugs: Carboplatin
Specified dose on specified days
Treatment: Drugs: Gemcitabine
Specified dose on specified days
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Intervention code [1]
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0
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)
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Assessment method [1]
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Assessed using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by blinded independent central review (BICR)
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Timepoint [1]
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Approximately 31 months from first participant randomization
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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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0
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Timepoint [1]
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Approximately up to 57 months from first participant randomization
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Secondary outcome [2]
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Recommended Phase 3 Dose (RP3D) of BMS-986507
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Assessment method [2]
0
0
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Timepoint [2]
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Approximately 19 months from first participant randomization
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Secondary outcome [3]
0
0
Number of participants with treatment-related Adverse Events (AEs)
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Assessment method [3]
0
0
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Timepoint [3]
0
0
Approximately up to 57 months from first participant randomization
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Secondary outcome [4]
0
0
Number of participants with laboratory abnormalities
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Assessment method [4]
0
0
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Timepoint [4]
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0
Approximately up to 57 months from first participant randomization
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Secondary outcome [5]
0
0
Number of participants with serious AEs (SAEs)
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Assessment method [5]
0
0
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Timepoint [5]
0
0
Approximately up to 57 months from first participant randomization
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Secondary outcome [6]
0
0
Number of participants with AEs leading to treatment discontinuation, interruption, dose reduction or dose delay
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Assessment method [6]
0
0
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Timepoint [6]
0
0
Approximately up to 57 months from first participant randomization
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Secondary outcome [7]
0
0
Number of deaths
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Assessment method [7]
0
0
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Timepoint [7]
0
0
Approximately up to 57 months from first participant randomization
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Secondary outcome [8]
0
0
Objective Response (OR)
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Assessment method [8]
0
0
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Timepoint [8]
0
0
Approximately 31 months from first participant randomization
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Secondary outcome [9]
0
0
PFS rate
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Assessment method [9]
0
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Assessed using RECIST v1.1 by BICR
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Timepoint [9]
0
0
Approximately 31 months from first participant randomization
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Secondary outcome [10]
0
0
PFS
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Assessment method [10]
0
0
Assessed by Investigator
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Timepoint [10]
0
0
Approximately 31 months from first participant randomization
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Secondary outcome [11]
0
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Disease control rate (DCR)
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Assessment method [11]
0
0
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Timepoint [11]
0
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Approximately 31 months from first participant randomization
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Secondary outcome [12]
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Duration of Response (DOR)
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Assessment method [12]
0
0
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Timepoint [12]
0
0
Approximately 31 months from first participant randomization
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Secondary outcome [13]
0
0
Time to Response (TTR)
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Assessment method [13]
0
0
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Timepoint [13]
0
0
Approximately 31 months from first participant randomization
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Secondary outcome [14]
0
0
Time to subsequent treatment (TTST)
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Assessment method [14]
0
0
Defined as time from randomization to the start of subsequent therapy or death
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Timepoint [14]
0
0
Approximately up to 57 months from first participant randomization
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Secondary outcome [15]
0
0
Progression-free survival after next line of treatment (PFS2)
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Assessment method [15]
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0
Defined as the time from randomization to the date of investigator-defined documented disease progression after next line of treatment or death due to any cause, whichever comes first
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Timepoint [15]
0
0
Approximately up to 57 months from first participant randomization
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Secondary outcome [16]
0
0
Change from baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
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Assessment method [16]
0
0
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Timepoint [16]
0
0
Approximately up to 57 months from first participant randomization
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Secondary outcome [17]
0
0
Change from baseline in EORTC Breast Cancer-specific Quality of Life Questionnaire (QLQ-BR23)
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Assessment method [17]
0
0
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Timepoint [17]
0
0
Approximately up to 57 months from first participant randomization
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Secondary outcome [18]
0
0
Functional Assessment of Chronic Illness Therapy item GP5 (FACIT GP5) score
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Assessment method [18]
0
0
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Timepoint [18]
0
0
Approximately up to 57 months from first participant randomization
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Secondary outcome [19]
0
0
Change from baseline in European Quality of Life 5 Dimensions 5 Levels (EQ-5D-5L)
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Assessment method [19]
0
0
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Timepoint [19]
0
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Approximately up to 57 months from first participant randomization
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Eligibility
Key inclusion criteria
* Histologically or cytologically confirmed and documented locally-advanced, recurrent inoperable, or metastatic TNBC (ER < 1%, PgR < 1%, HER2 IHC 0, 1+, or 2+ with FISH negative for HER2 gene amplification) or ER-low, HER2-negative BC (ER and / or PgR 1% to 10%, HER2 IHC 0, 1+, or 2+ with FISH negative for HER2 gene amplification) per ASCO/CAP criteria, based on the most recently analyzed biopsy or other pathology specimen.
* Patients with recurrent disease must have experienced disease relapse at least 6 months after finishing their last therapy with curative intent.
* Patients with TNBC must be considered ineligible for 1L chemotherapy combination treatment with an anti-PD-1 or an anti-PD-L1 due to either one of the following criteria:.
* Investigator-determined ineligibility based on PD-L1 negative disease determined and documented prior to trial screening as part of SoC.
* Has experienced disease relapse between 6 to 12 months after the completion of (neo)adjuvant therapy with an anti-PD(L)1.
* Has a severe auto-immune disease or other contraindication.
* Patients with ER-low, HER2-negative BC must be ineligible, in the opinion of the Investigator, for endocrine therapy-based treatments.
* No previous systemic therapy in the locally advanced, recurrent inoperable or metastatic setting (ie incurable setting).
* Measurable disease by CT or MRI as per RECIST v1.1.
* Other protocol-defined Inclusion/
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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
Exclusion criteria 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 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet 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
15/07/2025
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Actual
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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
15/05/2030
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Actual
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Sample size
Target
560
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD,VIC,WA
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Recruitment hospital [1]
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Local Institution - 0035 - Brisbane
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Recruitment hospital [2]
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Local Institution - 0197 - Ballarat Central
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Recruitment hospital [3]
0
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Local Institution - 0031 - Heidelberg
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Recruitment hospital [4]
0
0
Local Institution - 0274 - Melbourne
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Recruitment hospital [5]
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Local Institution - 0028 - Subiaco
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Recruitment postcode(s) [1]
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4029 - Brisbane
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Recruitment postcode(s) [2]
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3350 - Ballarat Central
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Recruitment postcode(s) [3]
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3084 - Heidelberg
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Recruitment postcode(s) [4]
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3000 - Melbourne
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Recruitment postcode(s) [5]
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6008 - Subiaco
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Arkansas
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0
0
United States of America
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State/province [2]
0
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California
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0
0
United States of America
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0
0
Colorado
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0
0
United States of America
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State/province [4]
0
0
Delaware
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Florida
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Country [6]
0
0
United States of America
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State/province [6]
0
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Georgia
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Country [7]
0
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United States of America
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State/province [7]
0
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Illinois
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United States of America
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Louisiana
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United States of America
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Massachusetts
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United States of America
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Minnesota
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United States of America
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Missouri
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New York
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North Carolina
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Oregon
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Pennsylvania
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South Carolina
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Texas
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Virginia
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Argentina
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Buenos Aires
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Argentina
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Ciudad Autónoma De Buenos Aires
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Argentina
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Córdoba
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Argentina
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Santa Fe
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Argentina
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Ciudad Autónoma de Buenos Aires
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Argentina
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Cordoba
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Austria
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Steiermark
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Austria
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Tirol
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Austria
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Salzburg
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Austria
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St. Polten
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Austria
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Wien
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Brazil
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Amazonas
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Brazil
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Ceará
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Brazil
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Espírito Santo
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Brazil
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Rio Grande Do Sul
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Brazil
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São Paulo
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Brazil
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Rio de Janeiro
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British Columbia
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Canada
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Ontario
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Quebec
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Colombia
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Antioquia
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COR
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Colombia
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Cundinamarca
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Valle Del Cauca
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France
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Aquitaine
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France
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Côte-d'Or
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France
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Haute-Garonne
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France
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Hérault
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France
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Ille-et-Vilaine
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France
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Loire-Atlantique
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France
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Marne
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France
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Paris
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France
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Provence-Alpes-Côte-d'Azur
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France
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Puy-de-Dôme
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France
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Rhône-Alpes
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France
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State/province [55]
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Lille
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Country [56]
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Germany
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Baden-Württemberg
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Germany
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Bayern
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Germany
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Hessen
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Germany
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Nordrhein-Westfalen
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Germany
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Sachsen
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Germany
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Schleswig-Holstein
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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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Dresden
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Germany
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Hannover
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Germany
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Heidelberg
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Germany
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0
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Ulm
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Greece
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Attikí
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Greece
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Irakleío
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India
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Delhi
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India
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Maharashtra
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India
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Tamil Nadu
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India
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Telangana
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India
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Uttar Pradesh
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0
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Israel
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HaMerkaz
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0
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Israel
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HaTsafon
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Israel
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Yerushalayim
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Italy
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Campania
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Italy
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Emilia-Romagna
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Italy
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Friuli-Venezia Giulia
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Italy
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Liguria
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Italy
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Pisa
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Italy
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Toscana
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Italy
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Milano
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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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Roma
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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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Gunma
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Japan
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Hokkaido
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Japan
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Ishikawa
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Japan
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Kanagawa
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Japan
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Mie
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Miyagi
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Osaka
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Japan
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Saitama
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Japan
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Tokyo
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Fukuoka
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Fukushima
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0
0
Japan
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State/province [104]
0
0
Kagoshima
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Country [105]
0
0
Japan
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State/province [105]
0
0
Kyoto
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Country [106]
0
0
Japan
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State/province [106]
0
0
Okayama
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Country [107]
0
0
Korea, Republic of
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State/province [107]
0
0
Kyonggi-do
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Country [108]
0
0
Korea, Republic of
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State/province [108]
0
0
Seoul-teukbyeolsi [Seoul]
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Country [109]
0
0
Korea, Republic of
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State/province [109]
0
0
Taegu-Kwangyokshi
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Country [110]
0
0
Mexico
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State/province [110]
0
0
DIF
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Country [111]
0
0
Mexico
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State/province [111]
0
0
Jalisco
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Country [112]
0
0
Mexico
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State/province [112]
0
0
Nuevo León
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Country [113]
0
0
Mexico
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State/province [113]
0
0
Oaxaca
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Country [114]
0
0
Mexico
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State/province [114]
0
0
Yucatán
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Country [115]
0
0
Mexico
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State/province [115]
0
0
Chihuahua
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Country [116]
0
0
Poland
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State/province [116]
0
0
Lubelskie
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Country [117]
0
0
Poland
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State/province [117]
0
0
Mazowieckie
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Country [118]
0
0
Poland
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State/province [118]
0
0
Opolskie
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Country [119]
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0
Poland
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State/province [119]
0
0
Wielkopolskie
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Country [120]
0
0
Poland
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State/province [120]
0
0
Lódzkie
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Country [121]
0
0
Portugal
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State/province [121]
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0
Lisboa
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Country [122]
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0
Portugal
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State/province [122]
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0
Coimbra
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Country [123]
0
0
Portugal
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State/province [123]
0
0
Porto
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Country [124]
0
0
Romania
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State/province [124]
0
0
Bistri?a-Nasaud
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Country [125]
0
0
Romania
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State/province [125]
0
0
Bucure?ti
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Country [126]
0
0
Romania
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State/province [126]
0
0
Cluj
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Country [127]
0
0
Romania
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State/province [127]
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0
Dolj
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Country [128]
0
0
Romania
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State/province [128]
0
0
Prahova
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Country [129]
0
0
Romania
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State/province [129]
0
0
Timi?
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Country [130]
0
0
Romania
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State/province [130]
0
0
Ia?i
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Country [131]
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0
Spain
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State/province [131]
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0
A Coruña [La Coruña]
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Country [132]
0
0
Spain
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State/province [132]
0
0
Alicante
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Country [133]
0
0
Spain
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State/province [133]
0
0
Barcelona [Barcelona]
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Country [134]
0
0
Spain
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State/province [134]
0
0
Catalunya [Cataluña]
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Country [135]
0
0
Spain
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State/province [135]
0
0
Gipuzkoa
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Country [136]
0
0
Spain
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State/province [136]
0
0
Madrid, Comunidad De
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Country [137]
0
0
Spain
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State/province [137]
0
0
Málaga
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Country [138]
0
0
Spain
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State/province [138]
0
0
Valenciana, Comunitat
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Country [139]
0
0
Spain
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State/province [139]
0
0
Madrid
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Country [140]
0
0
Spain
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State/province [140]
0
0
Sevilla
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Country [141]
0
0
Sweden
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State/province [141]
0
0
Skåne Län [se-12]
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Country [142]
0
0
Sweden
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State/province [142]
0
0
Stockholms Län [se-01]
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Country [143]
0
0
Sweden
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State/province [143]
0
0
Uppsala Län [se-03]
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Country [144]
0
0
Sweden
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State/province [144]
0
0
Örebro Län [se-18]
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Country [145]
0
0
Sweden
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State/province [145]
0
0
Östergötlands Län [se-05]
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Country [146]
0
0
Switzerland
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State/province [146]
0
0
Sankt Gallen
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Country [147]
0
0
Switzerland
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State/province [147]
0
0
Vaud
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Country [148]
0
0
Switzerland
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State/province [148]
0
0
Zürich
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Country [149]
0
0
United Arab Emirates
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State/province [149]
0
0
Abu Z¸aby
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Country [150]
0
0
United Arab Emirates
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State/province [150]
0
0
Abu Dhabi
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Country [151]
0
0
United Kingdom
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State/province [151]
0
0
England
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Country [152]
0
0
United Kingdom
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State/province [152]
0
0
London, City Of
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Country [153]
0
0
United Kingdom
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State/province [153]
0
0
Belfast
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Country [154]
0
0
United Kingdom
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State/province [154]
0
0
London
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Country [155]
0
0
United Kingdom
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State/province [155]
0
0
Manchester
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Country [156]
0
0
United Kingdom
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State/province [156]
0
0
Nottingham
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Bristol-Myers Squibb
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Address
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Country
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Other collaborator category [1]
0
0
Commercial sector/industry
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Name [1]
0
0
SystImmune Inc.
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Address [1]
0
0
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Country [1]
0
0
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to assess the efficacy and safety of iza-bren, a bi-specific antibody-drug conjugate against EGFR and HER3 with a topoisomerase inhibitor payload versus treatment of physician's choice (TPC) (paclitaxel, nab-paclitaxel, carboplatin plus gemcitabine, and capecitabine) for the treatment of first-line metastatic triple-negative breast cancer (TNBC) or estrogen receptor (ER)-low, human epidermal growth factor receptor 2 (HER2)-negative BC patients who are not candidates for anti-PD(L)1 therapy and endocrine therapies.
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Trial website
https://clinicaltrials.gov/study/NCT06926868
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Bristol-Myers Squibb
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Address
0
0
Bristol-Myers Squibb
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
BMS Study Connect Contact Center www.BMSStudyConnect.com
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Address
0
0
Query!
Country
0
0
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Phone
0
0
855-907-3286
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Fax
0
0
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Email
0
0
[email protected]
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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
Query!
What data in particular will be shared?
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria.
Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at:
https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
Query!
When will data be available (start and end dates)?
See Plan Description
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Available to whom?
See Plan Description
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Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
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/NCT06926868
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