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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02278120
Registration number
NCT02278120
Ethics application status
Date submitted
22/10/2014
Date registered
29/10/2014
Date last updated
12/03/2024
Titles & IDs
Public title
Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer
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Scientific title
A Phase III Randomized, Double-blind, Placebo-controlled Study of LEE011 or Placebo in Combination With Tamoxifen and Goserelin or a Non-steroidal Aromatase Inhibitor (NSAI) and Goserelin for the Treatment of Premenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer
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Secondary ID [1]
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2014-001931-36
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Secondary ID [2]
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CLEE011E2301
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Universal Trial Number (UTN)
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Trial acronym
MONALEESA-7
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced Metastatic 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 - Ribociclib
Treatment: Drugs - Tamoxifen
Treatment: Drugs - Letrozole
Treatment: Drugs - Anastrozole
Treatment: Drugs - Goserelin
Treatment: Drugs - Placebo
Experimental: Ribociclib + NSAI/tamoxifen + goserelin - Ribociclib 600 mg daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days)
Placebo Comparator: Placebo + NSAI/tamoxifen + goserelin - Placebo daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days).
Participants were unblinded once the final OS analysis was conducted and after the implementation of protocol amendment 6 (16-Jul-2019) and were given the option to crossover to treatment with ribociclib +NSAI/tamoxifen + goserelin.
Treatment: Drugs: Ribociclib
Ribociclib (600 mg, in three 200 mg hard gelatin capsules) was administered orally once daily on Days 1-21 of each 28-day cycle.
Treatment: Drugs: Tamoxifen
Tamoxifen (20 mg, tablets) was administered orally on a continuous daily schedule (days 1-28 of each 28-day cycle)
Treatment: Drugs: Letrozole
Letrozole (2.5 mg, tablets) was administered orally once daily on a continuous daily schedule (days 1-28 of each 28-day cycle)
Treatment: Drugs: Anastrozole
Anastrozole (1 mg, tablets) was administered orally once daily on a continuous daily schedule (days 1-28 of each 28-day cycle)
Treatment: Drugs: Goserelin
Goserelin (3.6 mg, subcutaneous implant) was administered on day 1 of every 28-day cycle
Treatment: Drugs: Placebo
Placebo (hard gelatin capsules) was administered orally once daily on Days 1-21 of each 28-day cycle.
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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) by Investigator Assessment
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Assessment method [1]
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PFS was defined as the period starting from the date of randomization to the date of the first documented progression or death caused by any reason. In cases where patients did not experience an event, the PFS was censored at the date of the last adequate tumor assessment. Clinical deterioration without objective radiological evidence was not considered as documented disease progression. PFS was assessed via local radiology assessment according to RECIST 1.1. As per protocol, the final PFS analysis was conducted after approximately 392 PFS events were documented. The Kaplan-Meier method was used to estimate PFS, and the median PFS, along with 95% confidence intervals, was reported for each treatment group. A stratified Cox regression model was used to estimate the hazard ratio of PFS, along with 95% confidence interval
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Timepoint [1]
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From randomization to first documented progression or death, assessed up to approximately 29 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 was defined as the time from the date of randomization to the date of death from any cause. In cases where the patient's death was not recorded, the OS value was censored at the date of the last known patient's survival status. OS was estimated using the Kaplan-Meier method. As per protocol, the final OS analysis was conducted after approximately 189 deaths were documented.
The median OS, along with 95% confidence intervals, was reported for each treatment group.The distribution of OS between the two treatment arms was compared using a log-rank test at one-sided cumulative 2.5% level of significance. A stratified Cox regression was used to estimate the OS hazard ratio and the associated 95% CI.
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Timepoint [1]
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From randomization to death, assessed up to approximately 45 months
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Secondary outcome [2]
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Overall Response Rate (ORR) by Investigator Assessment
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Assessment method [2]
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ORR is the percentage of participants with the best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1 as per local assessment. CR = Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR = At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
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Timepoint [2]
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Up to approximately 29 months
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Secondary outcome [3]
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Clinical Benefit Rate (CBR) by Investigator Assessment
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Assessment method [3]
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Percentage of participants with complete response (CR) or partial response (PR) or stable disease (SD) lasting 24 weeks or longer as defined in RECIST 1.1 and local assessment. CR = Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR = At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters; SD = Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease: PD = At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20% the sum must also demonstrate an absolute increase of at least 5 mm.
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Timepoint [3]
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Up to approximately 29 months
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Secondary outcome [4]
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Time to Response (TTR) by Investigator Assessment
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Assessment method [4]
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Time to response is the time from the date of randomization to the first documented response (CR or PR, which must be confirmed subsequently) according to RECIST 1.1 as per local assessment. The Kaplan-Meier method was used to estimate TTR, and the median TTR, along with 95% confidence intervals, was reported for each treatment group. Participants who did not achieve a confirmed response were censored at the maximum follow-up time for patients who had a PFS event (i.e. either progressed or died due to any cause) or at the date of last adequate tumor assessment otherwise.
CR = Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR = At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
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Timepoint [4]
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Up to approximately 29 months
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Secondary outcome [5]
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Duration of Response (DOR) by Investigator Assessment
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Assessment method [5]
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DOR was defined as the time from the first documented response (CR or PR) to the first documented progression or death due to underlying cancer as defined in RECIST 1.1 per investigator assessment. The Kaplan-Meier method was used to estimate DOR, and the median DOR, along with 95% confidence intervals, was reported for each treatment group. If a participant had not had an event, duration was censored at the date of last adequate tumor assessment.
CR = Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR = At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
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Timepoint [5]
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Up to approximately 29 months
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Secondary outcome [6]
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Time to Definitive Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) by at Least One Category of the Score
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Assessment method [6]
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ECOG PS categorized patients based on their ability to perform daily activities and self-care, with scores ranging from 0 to 5. A score of 0 indicated no restrictions in activity, while higher scores indicated increasing limitations. Time to definitive deterioration was defined as the time from the date of randomization to the date of the event, defined as experiencing an increase in ECOG PS by at least one category from the baseline or death. A deterioration was considered definitive if no improvements in the ECOG PS were observed at a subsequent time. The Kaplan-Meier method was used to estimate the distribution, and the median time to definitive deterioration, along with 95% confidence intervals, was reported for each treatment group. Patients receiving any further therapy prior to definitive worsening were censored at their date of last assessment prior to start of therapy. Patients that had not worsened at the data cutoff point were censored at the date of last assessment.
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Timepoint [6]
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Baseline, up to approximately 29 months
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Secondary outcome [7]
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Time to Definitive 10% Deterioration in the Global Health Status/Quality of Life (GHS/QoL) Scale Score of the European Organization for Research and Treatment of Cancer's Core Quality of Life Questionnaire (EORTC QLQ-C30)
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Assessment method [7]
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The EORTC QLQ-C30 is a questionnaire that includes 5 functional scales, 3 symptom scales, 1 GHS/QoL scale, and 6 single items. GHS/QoL scale score ranges between 0 and 100. A high score for GHS/QoL represents better functioning or QoL.The time to definitive 10% deterioration is defined as the time from the date of randomization to the date of event, which is defined as at least 10% relative to baseline worsening of the QoL score (without further improvement above the threshold) or death due to any cause. The Kaplan-Meier method was used to estimate the distribution, and the median time to definitive 10% deterioration, along with 95% confidence intervals, was reported for each treatment group. If a patient had not had an event, time to deterioration was censored at the date of the last adequate QoL evaluation.
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Timepoint [7]
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Up to approximately 29 months
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Secondary outcome [8]
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Change From Baseline in the GHS/QoL Scale Score of the EORTC QLQ-C30
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Assessment method [8]
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The EORTC QLQ-C30 is a questionnaire that includes 5 functional scales, 3 symptom scales, 1 GHS/QoL scale, and 6 single items. GHS/QoL scale score ranges between 0 and 100. A high score for GHS/QoL represents better functioning or QoL.The change from baseline in the GHS/QoL score was assessed. A positive change from baseline indicated improvement. For subjects who discontinued treatment without disease progression, post-treatment efficacy visits occurred every 8 weeks during the initial 18 months since start of treatment, followed by visits every 12 weeks until disease progression.
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Timepoint [8]
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Baseline, every 2 cycles after randomization during 18 months, then every 3 cycles up to end of treatment (EOT); EOT; and every 8 or 12 weeks post-treatment until progression, assessed up to approximately 29 months. Cycle=28 days
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Eligibility
Key inclusion criteria
Key inclusion criteria:
- Patients had advanced (locoregionally recurrent or metastatic) breast cancer not
amenable to curative therapy
- Patients were premenopausal or perimenopausal at the time of study entry
- Patients who had received (neo) adjuvant therapy for breast cancer were eligible
- Patients had a histologically and/or cytologically confirmed diagnosis of
estrogen-receptor positive and/or progesterone receptor positive breast cancer
- Patients had HER2-negative breast cancer
- Patients must have either had measurable disease or If no measurable disease was
present, then at least one predominantly lytic bone lesion
- Patients had an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Patients had adequate bone marrow and organ function
Key exclusion criteria:
- Patients who had received a prior CDK4/6 inhibitor
- Patients were postmenopausal
- Patients who currently had inflammatory breast cancer at screening.
- Patients who had received any prior hormonal anti-cancer therapy for advanced breast
cancer, except for = 14 days of tamoxifen or NSAI ± goserelin for advanced breast
cancer prior to randomization.
- Patients had a concurrent malignancy or malignancy within 3 years of randomization,
with the exception of adequately treated basal cell skin carcinoma, squamous cell skin
carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer.
- Patients with CNS metastases.
- Patients had active cardiac disease or a history of cardiac dysfunction
- Patients were currently using other antineoplastic agents
- Patients were pregnant or nursing or physiologically capable of becoming pregnant and
not using highly effective contraception.
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Minimum age
18
Years
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Maximum age
59
Years
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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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
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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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
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
20/11/2014
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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
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Actual
20/04/2023
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Sample size
Target
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Accrual to date
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Final
672
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Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
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Recruitment hospital [1]
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Novartis Investigative Site - Waratah
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Recruitment hospital [2]
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Novartis Investigative Site - Box Hill
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Novartis Investigative Site - Heidelberg
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Novartis Investigative Site - Murdoch
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Recruitment hospital [5]
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Novartis Investigative Site - Nedlands
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Recruitment postcode(s) [1]
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2298 - Waratah
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Recruitment postcode(s) [2]
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3128 - Box Hill
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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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6150 - Murdoch
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Recruitment postcode(s) [5]
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6009 - Nedlands
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Recruitment outside Australia
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Italy
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State/province [84]
0
0
LE
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0
0
Italy
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LU
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Italy
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MC
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0
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Italy
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0
MI
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Country [88]
0
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Italy
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0
PG
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Country [89]
0
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Italy
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0
PO
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Country [90]
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Italy
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PV
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Country [91]
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Italy
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State/province [91]
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RM
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Country [92]
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Italy
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State/province [92]
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TO
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Country [93]
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Italy
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State/province [93]
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0
TR
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Country [94]
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Italy
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State/province [94]
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UD
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Country [95]
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Italy
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State/province [95]
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Napoli
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Country [96]
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Korea, Republic of
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State/province [96]
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Gyeonggi Do
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Country [97]
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Korea, Republic of
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State/province [97]
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Korea
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Country [98]
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Korea, Republic of
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State/province [98]
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Seoul
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Country [99]
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Lebanon
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State/province [99]
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LBN
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Country [100]
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Lebanon
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State/province [100]
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Ashrafieh
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Country [101]
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Lebanon
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State/province [101]
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Beirut
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Country [102]
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Lebanon
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State/province [102]
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Saida
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Country [103]
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Malaysia
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State/province [103]
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Johor
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Country [104]
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Malaysia
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State/province [104]
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Kuala Lumpur
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Country [105]
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Mexico
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State/province [105]
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Edo. De México
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Country [106]
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Mexico
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State/province [106]
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Guanajuato
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Country [107]
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Mexico
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State/province [107]
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Monterrey
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Country [108]
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Poland
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State/province [108]
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Gdansk
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Country [109]
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Poland
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State/province [109]
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Konin
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Country [110]
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Portugal
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State/province [110]
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Lisboa
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Country [111]
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Portugal
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State/province [111]
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Porto
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Country [112]
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Russian Federation
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State/province [112]
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Arkhangelsk
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Country [113]
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Russian Federation
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State/province [113]
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Saint Petersburg
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Country [114]
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Saudi Arabia
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State/province [114]
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Riyadh
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Country [115]
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Singapore
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State/province [115]
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Singapore
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Country [116]
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Spain
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State/province [116]
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Alicante
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Country [117]
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Spain
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State/province [117]
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Andalucia
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Country [118]
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Spain
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State/province [118]
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Barcelona
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Country [119]
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Spain
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State/province [119]
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Catalunya
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Country [120]
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Spain
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State/province [120]
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Comunidad Valenciana
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Country [121]
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Spain
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Galicia
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Country [122]
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Spain
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State/province [122]
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Islas Baleares
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Country [123]
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Spain
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State/province [123]
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Madrid
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Country [124]
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Spain
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State/province [124]
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Pais Vasco
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Country [125]
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Spain
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State/province [125]
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Vizcaya
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Country [126]
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Switzerland
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State/province [126]
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Geneve
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Country [127]
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Taiwan
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State/province [127]
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Changhua
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Country [128]
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Taiwan
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State/province [128]
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Kaohsiung
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Country [129]
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Taiwan
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State/province [129]
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New Taipei City
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Country [130]
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Taiwan
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State/province [130]
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Taipei
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Country [131]
0
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Taiwan
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State/province [131]
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Taoyuan
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Country [132]
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Thailand
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State/province [132]
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Bangkok
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Country [133]
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Turkey
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State/province [133]
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TUR
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Country [134]
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Turkey
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State/province [134]
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Adana
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Country [135]
0
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Turkey
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State/province [135]
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Ankara
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Country [136]
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Turkey
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State/province [136]
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Diyarbakir
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Country [137]
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Turkey
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State/province [137]
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Edirne
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Country [138]
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Turkey
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State/province [138]
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Izmir
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Country [139]
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United Arab Emirates
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State/province [139]
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Al Ain Abu Dhabi
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis Pharmaceuticals
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Address
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Ethics approval
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Summary
Brief summary
The purpose of this study was to determine whether treatment with tamoxifen or a
non-steroidal aromatase inhibitors (NSAI) + goserelin + LEE011 prolonged progression-free
survival (PFS) compared to treatment with tamoxifen or a NSAI + goserelin + placebo in
premenopausal women with hormone receptor positive (HR+), human epidermal growth factor
receptor 2 negative (HER2-) advanced breast cancer.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02278120
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Public notes
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Contacts
Principal investigator
Name
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Novartis Pharmaceuticals
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Novartis Pharmaceuticals
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02278120
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