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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06112379
Registration number
NCT06112379
Ethics application status
Date submitted
12/10/2023
Date registered
1/11/2023
Date last updated
12/06/2024
Titles & IDs
Public title
A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer
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Scientific title
A Phase III, Open-label, Randomised Study of Neoadjuvant Datopotamab Deruxtecan (Dato-DXd) Plus Durvalumab Followed by Adjuvant Durvalumab With or Without Chemotherapy Versus Neoadjuvant Pembrolizumab Plus Chemotherapy Followed by Adjuvant Pembrolizumab With or Without Chemotherapy for the Treatment of Adult Patients With Previously Untreated Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer (D926QC00001; TROPION-Breast04)
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Secondary ID [1]
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D926QC00001
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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 Cancer
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Dato-DXd
Treatment: Drugs - Durvalumab
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - Doxorubicin
Treatment: Drugs - Epirubicin
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Carboplatin
Treatment: Drugs - Capecitabine
Treatment: Drugs - Olaparib
Experimental: Dato-DXd plus durvalumab - Participants receive durvalumab every 3 weeks (Q3W) + Dato-DXd Q3W as neoadjuvant therapy prior to surgery; followed by 9 cycles of durvaluamb Q3W as adjuvant therapy post-surgery. Adjuvant chemotherapy may be given in combination with durvalumab only if participants have residual disease.
Olaparib may be given for participants with gBRCA-positive tumours and residual disease
Adjuvant chemotherapy may be one of these:
1. Doxorubicin (Q3W) or epirubicin (Q3W) + cyclophosphamide (Q3W) for 4 cycles (12 weeks) followed by paclitaxel (weekly) and carboplatin (weekly or Q3W) for 4 cycles (12 weeks);
2. Doxorubicin (Q3W) or epirubicin (Q3W) + cyclophosphamide (Q3W) for 4 cycles (12 weeks) followed by paclitaxel (weekly) for 4 cycles (12 weeks);
3. Carboplatin (weekly or Q3W) + paclitaxel (weekly) for 4 cycles (12 weeks);
4. Capecitabine (Q3W) for 8 cycles.
Active comparator: Pembrolizumab plus chemotherapy - Participants receive pembrolizumab every 3 weeks (Q3W) + paclitaxel weekly + carboplatin (weekly or Q3W) x 4 cycles, followed by pembrolizumab Q3W + (doxorubicin OR epirubicin) + cyclophosphamide Q3W x 4 cycles as neoadjuvant therapy prior to surgery; followed by 9 cycles of pembrolizumab Q3W as adjuvant therapy post-surgery. Adjuvant capecitabine (Q3W) for 8 cycles may be given in combination with pembrolizumab only if participants have residual disease. Olaparib may be given for participants with gBRCA-positive tumours and residual disease.
Treatment: Drugs: Dato-DXd
Experimental drug IV infusion
Treatment: Drugs: Durvalumab
Experimental drug IV Infusion
Treatment: Drugs: Pembrolizumab
IV Infusion Active comparator
Treatment: Drugs: Doxorubicin
IV infusion Experimental/Active Comparator
Treatment: Drugs: Epirubicin
IV Infusion Experimental/Active Comparator
Treatment: Drugs: Cyclophosphamide
IV infusion Experimental/Active Comparator
Treatment: Drugs: Paclitaxel
IV infusion Experimental/Active Comparator
Treatment: Drugs: Carboplatin
IV infusion Experimental/Active Comparator
Treatment: Drugs: Capecitabine
Tablet Oral route of administration Experimental/Active Comparator
Treatment: Drugs: Olaparib
Tablet Oral route of administration Experimental/Active Comparator
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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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Pathologic Complete Response (pCR) in the experimental vs control arms
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Assessment method [1]
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pCR rate is defined as the proportion of participants who have no evidence by haematoxylin and eosin staining of residual invasive disease at the time of definitive surgery in the complete resected breast specimen and all sampled regional lymph nodes (ypT0/Tis ypN0) by blinded central evaluation.
The analysis will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy or receives another anticancer therapy.
The measure of interest will be the difference between the pCR rates.
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Timepoint [1]
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At the time of definitive surgery
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Primary outcome [2]
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Event-free survival (EFS) in the experimental vs control arms
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Assessment method [2]
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EFS is defined as the time from the date of randomisation until the date of the first occurrence of any of the following events: disease progression precluding surgery, disease recurrence (local, regional, distant, or contralateral), second primary non-breast invasive cancer (other than squamous or basal cell skin cancer), or death by any cause (in the absence of recurrence).
The analysis will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy or receives another anticancer therapy.
The measure of interest will be the Hazard Ratio of EFS.
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Timepoint [2]
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Date of randomization to date of the EFS event, up to 68 months after the first subject randomized
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Secondary outcome [1]
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Overall Survival (OS) in the experimental vs control arms
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Assessment method [1]
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OS is defined as the time from the date of randomisation until the date of death due to any cause.
The analysis will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy or receives another anticancer therapy.
The measure of interest will be the Hazard Ratio of OS.
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Timepoint [1]
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Date of randomization to date of death due to any cause, up to 82 months after the first subject randomized
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Secondary outcome [2]
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Distant disease-free survival (DDFS) in the experimental vs control arms
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Assessment method [2]
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DDFS is defined as the time from the date of randomisation until the date of the first occurrence of any of the following events: distant metastasis, occurrence of second primary non-breast invasive cancer (other than squamous or basal cell skin cancer), or death by any cause (in the absence of recurrence).
The analysis will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy or receives another anticancer therapy.
The measure of interest will be the Hazard Ratio of DDFS.
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Timepoint [2]
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Date of randomization to date of the DDFS event, up to 68 months after the first subject randomized
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Secondary outcome [3]
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Participant-reported breast and arm symptoms in the experimental vs. control arms
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Assessment method [3]
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Breast and arm symptoms measured by the EORTC IL116. The analysis will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy or receives another anticancer therapy.
The measure of interest is the mean between-arm difference in breast and arm symptom scores.
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Timepoint [3]
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From Cycle 1 Day 1 of neoadjuvant treatment until pre-surgery safety FU visit (for approximately 24 weeks) or EOT - whichever occurs first.
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Secondary outcome [4]
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Participant-reported physical function in the experimental vs. control arms
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Assessment method [4]
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Physical function measured by the PROMIS Physical Function Short Form 8c. The analysis will include all dosed participants. The measure of interest is the mean between-arm difference in physical function scores.
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Timepoint [4]
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From Cycle 1 Day 1 of neoadjuvant treatment until pre-surgery safety FU visit (for approximately 24 weeks) or EOT - whichever occurs first, and then from Cycle 1 Day 1 of adjuvant treatment until EOT (for approximately 27 weeks).
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Secondary outcome [5]
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Participant-reported fatigue in the experimental vs. control arms
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Assessment method [5]
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Fatigue measured by the PROMIS Fatigue Short Form 7a. The analysis will include all dosed participants. The measure of interest will be the difference on the proportions of participants reporting different levels of fatigue and mean between-arm difference in the fatigue scores.
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Timepoint [5]
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From Cycle 1 Day 1 of neoadjuvant treatment until pre-surgery safety FU visit (for approximately 24 weeks) or EOT - whichever occurs first, and then from Cycle 1 Day 1 of adjuvant treatment until EOT (for approximately 27 weeks).
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Secondary outcome [6]
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Participant-reported Global health status/Quality of life (GHS/QoL)in the experimental vs. control arms
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Assessment method [6]
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Global health status/Quality of life measured by EORTC IL172. The analysis will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy or receives another anticancer therapy.
The measure of interest is the mean between-arm difference in GHS/QoL scores.
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Timepoint [6]
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From Cycle 1 Day 1 of neoadjuvant treatment until pre-surgery safety FU visit (for approximately 24 weeks) or EOT - whichever occurs first, and then from Cycle 1 Day 1 of adjuvant treatment until EOT (for approximately 27 weeks).
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Secondary outcome [7]
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Pharmacokinetics of Dato-DXd (in combination with durvalumab)
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Assessment method [7]
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Plasma concentrations of Dato-DXd (ug/ml )
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Timepoint [7]
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Day 1 of cycles 1,2,4,8 (Each cycle is 21 days) and at pre-surgery safety follow up visit
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Secondary outcome [8]
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Pharmacokinetics of Dato-DXd (in combination with durvalumab)
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Assessment method [8]
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Plasma concentrations of total anti-TROP2 antibody (ug/ml )
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Timepoint [8]
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Day 1 of cycles 1,2,4,8 (Each cycle is 21 days) and at pre-surgery safety follow up visit
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Secondary outcome [9]
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Pharmacokinetics of Dato-DXd (in combination with durvalumab)
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Assessment method [9]
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Plasma concentrations of DXd (MAAA-1181a) (ng/ml)
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Timepoint [9]
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Day 1 of cycles 1,2,4,8 (Each cycle is 21 days) and at pre-surgery safety follow up visit
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Secondary outcome [10]
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Immunogenicity of Dato-DXd (in combination with durvalumab)
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Assessment method [10]
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Presence of antidrug antibodies (ADAs) for Dato-DXd (confirmatory results: positive or negative, titres).
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Timepoint [10]
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Day 1 of cycles 1,2,4,8 (Each cycle is 21 days) and at pre-surgery safety follow up visit
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Secondary outcome [11]
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Safety of Dato-DXd (in combination with durvalumab)
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Assessment method [11]
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Safety and tolerability will be evaluated in terms of AEs graded by CTCAE version 5.0
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Timepoint [11]
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Randomization to final safety follow-up visit, either 90 days after last dose of study intervention for those who complete planned study intervention or 90 days after date of discontinuation for those who discontinue study intervention prematurely
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Eligibility
Key inclusion criteria
* Participant must be = 18 years, at the time of signing the ICF.
* Histologically confirmed Stage II or III unilateral or bilateral primary invasive TNBC or hormone receptor-low/HER2-negative breast cancer
* ECOG PS of 0 or 1
* Provision of acceptable tumor sample
* Adequate bone marrow reserve and organ function
* Contraceptive use by males or females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
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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:
* History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 3 years before randomization and of low potential risk for recurrence.
* Evidence of distant disease.
* Clinically significant corneal disease.
* Has active or uncontrolled hepatitis B or C virus infection.
* Known HIV infection that is not well controlled.
* Uncontrolled infection requiring i.v. antibiotics, antivirals or antifungals; suspected infections; or inability to rule out infections.
* Known to have active tuberculosis infection
* Resting ECG with clinically significant abnormal findings.
* Uncontrolled or significant cardiac disease.
* History of non-infectious ILD/pneumonitis
* Any prior or concurrent surgery, radiotherapy or systemic anticancer therapy for TNBC or hormone receptor-low/HER2-negative breast cancer
* For females only: is pregnant (confirmed with positive serum pregnancy test) or breastfeeding, or planning to become pregnant.
* Female participants should refrain from breastfeeding from enrolment throughout the study and for at least 7 months after last dose of study intervention, or as dictated by local PI for SoC if longer.
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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
14/11/2023
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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
28/08/2030
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Actual
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Sample size
Target
1728
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Darlinghurst
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Research Site - East Melbourne
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Research Site - Heidelberg
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Research Site - Herston
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Recruitment hospital [5]
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Research Site - Nedlands
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Research Site - Waratah
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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3002 - East Melbourne
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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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4029 - Herston
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Recruitment postcode(s) [5]
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6009 - Nedlands
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Recruitment postcode(s) [6]
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2298 - Waratah
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Recruitment outside Australia
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China
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State/province [82]
0
0
Nanjing
Query!
Country [83]
0
0
China
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State/province [83]
0
0
Nanning
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Country [84]
0
0
China
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State/province [84]
0
0
Shanghai
Query!
Country [85]
0
0
China
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State/province [85]
0
0
Shenyang
Query!
Country [86]
0
0
China
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State/province [86]
0
0
Shijiazhuang
Query!
Country [87]
0
0
China
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State/province [87]
0
0
Suining
Query!
Country [88]
0
0
China
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State/province [88]
0
0
Suzhou
Query!
Country [89]
0
0
China
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State/province [89]
0
0
Tianjin
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Country [90]
0
0
China
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State/province [90]
0
0
Urumqi
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Country [91]
0
0
China
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State/province [91]
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Wuhan
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Country [92]
0
0
China
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State/province [92]
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0
Xi'an
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Country [93]
0
0
China
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State/province [93]
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0
Xintai
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Country [94]
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0
China
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State/province [94]
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0
Zhengzhou
Query!
Country [95]
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0
France
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State/province [95]
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Avignon
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Country [96]
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France
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Bayonne
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Country [97]
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France
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State/province [97]
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Caen Cedex 5
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Country [98]
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0
France
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State/province [98]
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0
Clermont Ferrand
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Country [99]
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0
France
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0
Limoges
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Country [100]
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0
France
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Lyon
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Country [101]
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0
France
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Marseille
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Country [102]
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0
France
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Montpellier
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Country [103]
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0
France
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Nice
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Country [104]
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0
France
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Paris
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Country [105]
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0
France
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Reims Cedex
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France
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Saint Herblain
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Country [107]
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France
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Toulouse
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France
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0
Vandoeuvre les Nancy
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France
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Villejuif Cedex
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Germany
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Augsburg
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Germany
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Berlin
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Germany
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Dessau-Roßlau
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Germany
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Dresden
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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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Esslingen am Neckar
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Germany
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Frankfurt am Main
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0
Germany
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Freiburg
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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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Kiel
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Germany
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Mainz
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Germany
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Mannheim
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0
Germany
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München
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0
Germany
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Münster
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0
Germany
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Trier
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Germany
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Ulm
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Hong Kong
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Hong Kong
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Hong Kong
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Kwai Chung
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Hungary
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Budapest
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Hungary
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Kecskemét
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Hungary
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Miskolc
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Hungary
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Nyíregyháza
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Hungary
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Salgótarján
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Hungary
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Szekszárd
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India
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Bengaluru
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India
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Dehradun
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India
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Delhi
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India
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Kolkata
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India
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Marg Jaipur
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0
India
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Nagpur
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0
India
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Nashik
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India
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Puducherry
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0
India
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Thiruvananthapuram
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India
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Vadodara
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Italy
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Empoli
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Italy
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Lucca
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Italy
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State/province [148]
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Macerata
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Country [149]
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Italy
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State/province [149]
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Milano
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Country [150]
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Italy
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State/province [150]
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Modena
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Country [151]
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Italy
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State/province [151]
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Napoli
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Country [152]
0
0
Italy
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Padova
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Country [153]
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0
Italy
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Roma
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Country [154]
0
0
Italy
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State/province [154]
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0
Rozzano
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Country [155]
0
0
Italy
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State/province [155]
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Torino
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Country [156]
0
0
Italy
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State/province [156]
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0
Tricase
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Country [157]
0
0
Italy
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State/province [157]
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Udine
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Country [158]
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0
Japan
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State/province [158]
0
0
Akashi-shi
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Country [159]
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0
Japan
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State/province [159]
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0
Akita-shi
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Country [160]
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0
Japan
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State/province [160]
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0
Bunkyo-ku
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Country [161]
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0
Japan
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State/province [161]
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0
Chiba-shi
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0
Japan
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State/province [162]
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Chuo-ku
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Country [163]
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0
Japan
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State/province [163]
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0
Fukuoka-shi
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0
Japan
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Fukushima-shi
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Japan
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Gifu-shi
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Country [166]
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0
Japan
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Hidaka-shi
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Japan
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Hirakata-shi
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Country [168]
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Japan
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State/province [168]
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Hiroshima-shi
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Country [169]
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Japan
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State/province [169]
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Isehara-shi
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Country [170]
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Japan
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Kashiwa
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Japan
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State/province [171]
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Koto-ku
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Country [172]
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0
Japan
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State/province [172]
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0
Kumamoto-shi
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Country [173]
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Japan
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State/province [173]
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Kurume-shi
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Country [174]
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Japan
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State/province [174]
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Matsuyama-shi
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Country [175]
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Japan
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State/province [175]
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0
Nagoya-shi
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Country [176]
0
0
Japan
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State/province [176]
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0
Niigata-shi
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Country [177]
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0
Japan
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State/province [177]
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Okayama
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Country [178]
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0
Japan
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State/province [178]
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Osaka-shi
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0
Japan
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State/province [179]
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0
Sapporo-shi
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Country [180]
0
0
Japan
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State/province [180]
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0
Sendai-shi
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Country [181]
0
0
Japan
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State/province [181]
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0
Shinagawa-ku
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Country [182]
0
0
Japan
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State/province [182]
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0
Shinjuku-ku
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Country [183]
0
0
Japan
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State/province [183]
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0
Sunto-gun
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Country [184]
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0
Japan
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State/province [184]
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Tokyo
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Country [185]
0
0
Japan
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State/province [185]
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0
Tsu-shi
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Country [186]
0
0
Japan
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State/province [186]
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0
Yokohama-shi
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Country [187]
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0
Korea, Republic of
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State/province [187]
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0
Daegu
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0
Korea, Republic of
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Goyang-si
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Korea, Republic of
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Seongnam
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Korea, Republic of
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Seoul
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0
Malaysia
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George Town
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Country [192]
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Malaysia
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Kuala Lumpur
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Malaysia
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Kuching
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Country [194]
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0
Malaysia
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State/province [194]
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Selangor
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Country [195]
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0
Poland
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Bialystok
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Poland
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Bydgoszcz
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Poland
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Gdansk
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Poland
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Gdynia
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Poland
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Tomaszów Mazowiecki
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Poland
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Warszawa
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Poland
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Wroclaw
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0
Poland
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State/province [202]
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Lódz
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Country [203]
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0
Singapore
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State/province [203]
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Singapore
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Country [204]
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0
Spain
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State/province [204]
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Barcelona
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0
Spain
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State/province [205]
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Granada
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Country [206]
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0
Spain
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State/province [206]
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0
Hospitalet deLlobregat
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Country [207]
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0
Spain
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State/province [207]
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Madrid
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Country [208]
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0
Spain
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State/province [208]
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0
Santiago de Compostela
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Country [209]
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Spain
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Sevilla
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Country [210]
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0
Spain
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State/province [210]
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0
Zaragoza
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Country [211]
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0
Switzerland
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State/province [211]
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Baden
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Country [212]
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0
Switzerland
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0
Basel
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Country [213]
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0
Switzerland
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Bern
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Country [214]
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0
Switzerland
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Frauenfeld
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Country [215]
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0
Switzerland
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State/province [215]
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0
Rennaz
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Country [216]
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0
Taiwan
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Changhua
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Country [217]
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0
Taiwan
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Kaohsiung
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Country [218]
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0
Taiwan
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Taichung
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0
Taiwan
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Tainan
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0
Taiwan
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State/province [220]
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0
Taipei
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Country [221]
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0
Taiwan
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Taoyuan
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Country [222]
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0
Thailand
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0
Bangkok
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Country [223]
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0
Thailand
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State/province [223]
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0
Dusit
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Country [224]
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0
Thailand
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0
Muang
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Country [225]
0
0
Thailand
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State/province [225]
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0
Songkhla
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Country [226]
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0
Turkey
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State/province [226]
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0
Adapazari
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Country [227]
0
0
Turkey
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State/province [227]
0
0
Ankara
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Country [228]
0
0
Turkey
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0
Istanbul
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Country [229]
0
0
Turkey
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0
Kayseri
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Country [230]
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0
Turkey
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State/province [230]
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0
Samsun
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Country [231]
0
0
United Kingdom
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State/province [231]
0
0
Birmingham
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Country [232]
0
0
United Kingdom
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0
0
Cardiff
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Country [233]
0
0
United Kingdom
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0
Edinburgh
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Country [234]
0
0
United Kingdom
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State/province [234]
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0
Guildford
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Country [235]
0
0
United Kingdom
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0
Lancaster
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Country [236]
0
0
United Kingdom
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0
London
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Country [237]
0
0
United Kingdom
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0
Northampton
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Country [238]
0
0
United Kingdom
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0
Oxford
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Country [239]
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0
Vietnam
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0
Hanoi
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Country [240]
0
0
Vietnam
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State/province [240]
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0
Ho Chi Minh city
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Country [241]
0
0
Vietnam
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State/province [241]
0
0
Vinh
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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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
Daiichi Sankyo
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Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
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Summary
Brief summary
This is a Phase III, 2-arm, randomised, open-label, multicentre, global study assessing the efficacy and safety of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy compared with neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy in participants with previously untreated TNBC or hormone receptor-low/HER2-negative breast cancer.
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Trial website
https://clinicaltrials.gov/study/NCT06112379
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
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Address
0
0
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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
AstraZeneca Clinical Study Information Center
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Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
1-877-240-9479
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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
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/study/NCT06112379
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