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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05382286
Registration number
NCT05382286
Ethics application status
Date submitted
16/05/2022
Date registered
19/05/2022
Titles & IDs
Public title
Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer
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Scientific title
A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer, Whose Tumors Express PD-L1
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Secondary ID [1]
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2021-005742-14
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Secondary ID [2]
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GS-US-592-6173
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Universal Trial Number (UTN)
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Trial acronym
ASCENT-04
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Triple Negative Breast Cancer
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PD-L1 Positive
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Sacituzumab Govitecan-hziy
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - Paclitaxel
Treatment: Drugs - nab-Paclitaxel
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Carboplatin
Experimental: Sacituzumab Govitecan-hziy (SG) + Pembrolizumab - Participants will receive SG 10 mg/kg on Days 1 and 8 of 21-day cycles and pembrolizumab 200 mg on Day 1 of 21-day cycles
Pembrolizumab will be administered for a maximum of 35 cycles.
Active comparator: Pembrolizumab + Treatment of Physician's Choice (TPC) - Participants will receive pembrolizumab 200 mg on Day 1 of each 21-day cycle (maximum 35 cycles) plus TPC determined prior to randomization from 1 of the 3 allowed regimens:
* Paclitaxel 90 mg/m\^2 on Days 1, 8, and 15 of 28-day cycles
* nab-Paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of 28-day cycles
* Gemcitabine 1000 mg/m\^2 + carboplatin area under the curve (AUC) 2 on Days 1 and 8 of 21-day cycles
Treatment: Drugs: Sacituzumab Govitecan-hziy
Administered intravenously
Treatment: Drugs: Pembrolizumab
Administered intravenously
Treatment: Drugs: Paclitaxel
Administered intravenously
Treatment: Drugs: nab-Paclitaxel
Administered intravenously
Treatment: Drugs: Gemcitabine
Administered intravenously
Treatment: Drugs: Carboplatin
Administered intravenously
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
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Assessment method [1]
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PFS is defined as the time from the date of randomization until the date of objective progressive disease (PD) or death (whichever comes first).
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Timepoint [1]
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Randomization up to approximately 33 months
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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OS is defined as the time from the date of randomization until death due to any cause.
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Timepoint [1]
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Randomization up to approximately 53 months
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Secondary outcome [2]
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Objective Response Rate (ORR) as Assessed by BICR per RECIST Version 1.1
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Assessment method [2]
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ORR is defined as the proportion of participants who achieve complete response (CR) or partial response (PR) that is confirmed at least 4 weeks after initial documentation of response.
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Timepoint [2]
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Randomization up to approximately 53 months
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Secondary outcome [3]
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Duration of Response (DOR) as Assessed by BICR per RECIST Version 1.1
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Assessment method [3]
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DOR is defined as the time from the first documentation of CR or PR to the earlier of the first documentation of objective PD or death from any cause (whichever comes first).
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Timepoint [3]
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Randomization up to approximately 53 months
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Secondary outcome [4]
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Time to Response (TTR) as Assessed by BICR per RECIST Version 1.1
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Assessment method [4]
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TTR is defined as the time from the date of randomization until the first documentation of CR or PR.
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Timepoint [4]
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Randomization up to approximately 53 months
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Secondary outcome [5]
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Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
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Assessment method [5]
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Timepoint [5]
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First dose date up to 53 months plus 30 days
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Secondary outcome [6]
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Percentage of Participants Experiencing Clinical Laboratory Abnormalities
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Assessment method [6]
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Timepoint [6]
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First dose date up to 53 months plus 30 days
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Secondary outcome [7]
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Time to Deterioration (TTD) in Global Health Status/Quality of Life (QoL) Scale as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Core Questionnaire, Version 3.0 (EORTC QLQ-C30)
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Assessment method [7]
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The EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer patients, it is composed of 30 questions (items) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Scoring of the QLQ-C30 is performed according to QLQ-C30 Scoring manual. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the participant), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the participant).
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Timepoint [7]
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Randomization up to approximately 53 months
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Secondary outcome [8]
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TTD of Pain Score as Measured by EORTC QLQ-C30
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Assessment method [8]
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The EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer patients, it is composed of 30 questions (items) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Scoring of the QLQ-C30 is performed according to QLQ-C30 Scoring manual. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the participant), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the participant).
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Timepoint [8]
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Randomization up to approximately 53 months
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Secondary outcome [9]
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TTD of Fatigue Score as Measured by EORTC QLQ-C30
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Assessment method [9]
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The EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer patients, it is composed of 30 questions (items) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Scoring of the QLQ-C30 is performed according to QLQ-C30 Scoring manual. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (ie, a better state of the participant), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (ie, a worse state of the participant).
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Timepoint [9]
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Randomization up to approximately 53 months
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Secondary outcome [10]
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TTD of Physical Functioning Domain Score as Measured by EORTC QLQ-C30
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Assessment method [10]
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The EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer patients, it is composed of 30 questions (items) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Scoring of the QLQ-C30 is performed according to QLQ-C30 Scoring manual. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (ie, a better state of the participant), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (ie, a worse state of the participant).
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Timepoint [10]
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Randomization up to approximately 53 months
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Secondary outcome [11]
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TTD of Role Functioning Score as Measured by EORTC QLQ-C30
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Assessment method [11]
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0
The EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer patients, it is composed of 30 questions (items) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Scoring of the QLQ-C30 is performed according to QLQ-C30 Scoring manual. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (ie, a better state of the participant), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (ie, a worse state of the participant).
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Timepoint [11]
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Randomization up to approximately 53 months
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Eligibility
Key inclusion criteria
Key
* Individuals with locally advanced, inoperable, or metastatic triple-negative breast cancer (TNBC) who have not received previous systemic therapy for advanced disease and whose tumors are programmed cell death ligand 1 (PD-L1) positive at screening.
* Individuals must have completed treatment for Stage I to III breast cancer, if indicated, and = 6 months must have elapsed between completion of treatment with curative intent and first documented local or distant disease recurrence.
* Individuals presenting with de novo metastatic TNBC are eligible for this study.
* TNBC status and tumor PD-L1 combined positive score (CPS) will be confirmed centrally on a recent or archival tumor specimen.
* Individuals must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria as evaluated locally.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
* Demonstrates adequate organ function
* Male and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.
* Individuals with HIV must be on antiretroviral therapy (ART) and have a well-controlled HIV infection/disease.
Key
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Positive serum pregnancy test or women who are lactating.
* Received prior therapy with an agent directed to another stimulatory or coinhibitory T-cell receptor.
* Individuals may not have received systemic anticancer treatment (with the exception of endocrine therapy) within the previous 6 months or radiation therapy within 2 weeks prior to enrollment.
* Individuals may not be participating in a study with an investigational agent or investigational device within 4 weeks prior to randomization. Individuals participating in observational studies are eligible.
* Have previously received topoisomerase 1 inhibitors or antibody drug conjugates containing a topoisomerase inhibitor.
* Have an active second malignancy.
* Have active serious infection requiring antibiotics.
* Individuals positive for HIV-1 or 2 with a history of Kaposi sarcoma and/or Multicentric Castleman Disease.
* Have active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
* Has an active autoimmune disease that has required systemic treatment in the past 2 years.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
25/07/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/02/2027
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Actual
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Sample size
Target
440
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
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Recruitment hospital [1]
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Border Medical Oncology - Albury
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Saint George Hospital - Australia - Kogarah
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Mater Hospital - North Sydney - North Sydney
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GenesisCare - North Shore - St Leonards
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Mater Misericordiae Limited and Mater Research Limited - South Brisbane
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Princess Alexandra Hospital - Woolloongabba
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Cancer Research SA (CRSA) - Adelaide
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Icon Cancer Centre Hobart - Hobart
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Monash Medical Centre - Clayton
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Austin Hospital - Melbourne
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Recruitment hospital [11]
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Peter MacCallum Cancer Centre - Parkville
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Recruitment hospital [12]
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Breast Cancer Research Center - Western Australia - Nedlands
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Recruitment postcode(s) [1]
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2640 - Albury
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2217 - Kogarah
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2060 - North Sydney
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2065 - St Leonards
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Recruitment postcode(s) [5]
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4101 - South Brisbane
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Recruitment postcode(s) [6]
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4102 - Woolloongabba
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Recruitment postcode(s) [7]
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5000 - Adelaide
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Recruitment postcode(s) [8]
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7000 - Hobart
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Recruitment postcode(s) [9]
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3168 - Clayton
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Recruitment postcode(s) [10]
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3084 - Melbourne
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Recruitment postcode(s) [11]
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3050 - Parkville
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Recruitment postcode(s) [12]
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6009 - Nedlands
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Recruitment outside Australia
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Providencia
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Santiago
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Olomouc
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0
Czechia
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State/province [80]
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Prague
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Czechia
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Praha
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France
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Avignon
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France
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Besancon
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France
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Bordeaux
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France
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Brest
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France
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Caen
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France
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Clermont Ferrand
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France
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Lyon
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France
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Marseille CEDEX 9
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France
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Montpellier Cedex 5
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France
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Montpellier
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France
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Nantes
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France
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Pierre-Benite
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France
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Plerin
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France
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Rennes Cedex
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France
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Toulouse
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France
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Villejuif
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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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Bottrop
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Germany
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Erlangen
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Germany
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Essen
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Germany
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Freiburg
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Germany
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Hamburg
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Germany
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Heidelberg
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Germany
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Köln
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Germany
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Lübeck
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Germany
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Mannheim
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Germany
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Munster
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Germany
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Mönchengladbach
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Germany
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München
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Germany
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Tübingen
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Germany
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Wiesbaden
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Hong Kong
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Hong Kong
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Hong Kong
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New Territories
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Gyor
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Israel
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Beer-Sheva
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Kfar Saba
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Israel
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Petah Tikva
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Israel
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Rehovot
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Israel
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Tel Aviv
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Italy
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Bari
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Italy
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Bologna
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Italy
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Brescia
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Italy
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Genova GE
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Italy
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Lecco
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Italy
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Lucca
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Italy
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Macerata
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Italy
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Milano
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Italy
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Milan
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Italy
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Monza
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Italy
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Napoli
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Italy
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Novara
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Italy
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Padova
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Italy
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Prato
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Italy
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Roma
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Italy
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Rome
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Italy
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Siena
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Japan
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Aichi
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Japan
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Aoba-ku
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Japan
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Bunkyo-ku
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Japan
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Chuo-ku
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Japan
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Ehime
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Japan
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Fukushima
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Japan
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Inamachi
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Japan
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Kagoshima-shi
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Japan
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Kanagawa
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Japan
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Kashiwa
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Japan
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Koto-ku
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Japan
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Kumamoto- shi
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Japan
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Kure
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Japan
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Mie
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Japan
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Nagoya
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Japan
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Naka-ku
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Japan
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Niigata-shi
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Japan
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Okayama
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Japan
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Ota
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Japan
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Sakyo-ku
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Japan
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Sapporo
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Japan
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Shizuoka-city
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Japan
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Shizuoka
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Japan
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State/province [166]
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Suita
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Japan
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Tokyo
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Japan
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Yokohama
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Korea, Republic of
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Goyang-si Gyeonggi-do
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Korea, Republic of
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Seongnam-si
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Korea, Republic of
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Seoul
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Malaysia
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Georgetown
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Malaysia
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Johor Bahru
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Malaysia
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Kuala Lumpur
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Malaysia
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Putrajaya
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Malaysia
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Sabah
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Malaysia
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Sarawak
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Mexico
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Chihuahua
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Mexico
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Ciudad de Mexico
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Mexico
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Culiacan
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Mexico
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Guadalajara
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Mexico
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Merida
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Mexico
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Monterrey
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Mexico
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México
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Mexico
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San Luis Potosi
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Mexico
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Veracruz
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Mexico
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Zapopan
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Netherlands
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Breda
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Netherlands
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Groningen
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Netherlands
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Leeuwarden
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Netherlands
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Rotterdam
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Poland
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Gdansk
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Poland
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Gliwice
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Poland
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Opole
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Poland
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Poznan
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Poland
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Siedlce
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Poland
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Warsaw
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Poland
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Warszawa
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Puerto Rico
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Ponce
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Puerto Rico
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San Juan
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Singapore
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Singapore
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South Africa
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Hilton
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South Africa
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Johannesburg
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South Africa
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Pretoria
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Spain
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A Coruña
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Spain
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Barcelona
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Spain
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Bilbo
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Spain
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Lleida
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Spain
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Madrid
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Spain
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Malaga
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Spain
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Murcia
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Spain
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Sevilla
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Spain
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Tenerife
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Spain
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Valencia
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Country [215]
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Switzerland
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Baden
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Switzerland
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Liestal
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Switzerland
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St. Gallen
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Switzerland
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Winterthur
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Switzerland
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Zürich
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Taiwan
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Changhua
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Taiwan
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Kaohsiung
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Taiwan
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New Taipei City
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Taiwan
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Tainan City
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Taiwan
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Tainan
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Taiwan
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Taipei City
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Taiwan
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Taipei
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0
Taiwan
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Taoyuan
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Turkey
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Adana
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Turkey
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Ankara
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Turkey
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Edirne
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Turkey
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Istanbul
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Turkey
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Izmir
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Turkey
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Sariyer
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Turkey
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Sisli
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Country [235]
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United Kingdom
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Edinburgh
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United Kingdom
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Glasgow
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United Kingdom
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Leeds
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0
United Kingdom
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0
London
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Country [239]
0
0
United Kingdom
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State/province [239]
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0
Nottingham
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Gilead Sciences
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Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/industry
Query!
Name [1]
0
0
Merck Sharp & Dohme LLC
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Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) and pembrolizumab versus treatment of physician's choice (TPC) and pembrolizumab in participants with previously untreated, locally advanced inoperable or metastatic triple-negative breast cancer, whose tumors express programmed cell death ligand 1 (PD-L1).
Query!
Trial website
https://clinicaltrials.gov/study/NCT05382286
Query!
Trial related presentations / publications
Query!
Public notes
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Contacts
Principal investigator
Name
0
0
Gilead Study Director
Query!
Address
0
0
Gilead Sciences
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Gilead Clinical Study Information Center
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
1-833-445-3230 (GILEAD-0)
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05382286