Register a trial

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.


Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements.
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04494425




Registration number
NCT04494425
Ethics application status
Date submitted
20/07/2020
Date registered
31/07/2020

Titles & IDs
Public title
Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer
Scientific title
A Phase 3, Randomized, Multi-center, Open-label Study of Trastuzumab Deruxtecan (T-DXd) Versus Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Breast Cancer Patients Whose Disease Has Progressed on Endocrine Therapy in the Metastatic Setting (DESTINY-Breast06)
Secondary ID [1] 0 0
2023-505554-18-00
Secondary ID [2] 0 0
D9670C00001
Universal Trial Number (UTN)
Trial acronym
DB-06
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced or Metastatic Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Trastuzumab deruxtecan
Treatment: Drugs - Capecitabine
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Nab-Paclitaxel

Experimental: Trastuzumab deruxtecan - Trastuzumab deruxtecan (T-DXd; DS-8201a) arm

Active comparator: Standard of Care - Investigator's choice standard of care chemotherapy (capecitabine, paclitaxel, nab-paclitaxel) arm


Treatment: Drugs: Trastuzumab deruxtecan
Trastuzumab deruxtecan by intravenous infusion

Treatment: Drugs: Capecitabine
Investigator's choice standard of care single agent chemotherapy; capecitabine tablets will be given orally.

Treatment: Drugs: Paclitaxel
Investigator's choice standard of care single agent chemotherapy; paclitaxel by intravenous infusion.

Treatment: Drugs: Nab-Paclitaxel
Investigator's choice standard of care single agent chemotherapy; nab-paclitaxel by intravenous infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS) Assessed by Blinded Independent Central Review (BICR) in the Hormone Receptor-Positive (HR+), Human Epidermal Growth Factor Receptor 2 (HER2)-Low Population
Assessment method [1] 0 0
PFS per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) assessed by BICR was defined as the time from the date of randomization until the date of PD, as defined or death (by any cause in the absence of progression) regardless of whether the participant withdrew from randomized therapy or received another anticancer therapy prior to progression. PD was defined as at least a 20% increase in the sum of diameters of target lesions (TLs), taking as reference the smallest previous sum of diameters (nadir), this included the baseline sum if that was the smallest on study. In addition to the relative increase of 20%, the sum must demonstrate an absolute increase of at least 5 millimeter (mm) from nadir. Median PFS was calculated using Kaplan-Meier method and its confidence interval (CI) using Brookmeyer-Crowley method.
Timepoint [1] 0 0
Response evaluations performed at screening, every 6 weeks (q6w) ± 1 week from randomization for 48 weeks, and then every 9 weeks (q9w) ± 1 week, starting at Week 48 until PD, up to PCD of 18 March 2024 (maximum of approximately 43.85 months)
Secondary outcome [1] 0 0
Overall Survival (OS) in the Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-low Population
Assessment method [1] 0 0
OS was defined as the time from the date of randomization until death due to any cause regardless of whether the participant withdrew from randomized therapy or received another anticancer therapy. Median OS was calculated using Kaplan-Meier method and its CI using Brookmeyer-Crowley method.
Timepoint [1] 0 0
From date of randomization until death due to any cause, up to PCD of 18 March 2024 (maximum of approximately 43.85 months)
Secondary outcome [2] 0 0
Progression-Free Survival Assessed by Blinded Independent Central Review in the Intent-to-Treat, Human Epidermal Growth Factor Receptor 2 Immunohistochemistry (IHC) >0 <1+ and Human Epidermal Growth Factor Receptor 2-low Population
Assessment method [2] 0 0
PFS per RECIST 1.1 assessed by BICR was defined as the time from the date of randomization until the date of PD, as defined or death (by any cause in the absence of progression) regardless of whether the participant withdrew from randomized therapy or received another anticancer therapy prior to progression. PD was defined as at least a 20% increase in the sum of diameters of TLs, taking as reference the smallest previous sum of diameters (nadir), this included the baseline sum if that was the smallest on study. In addition to the relative increase of 20%, the sum must demonstrate an absolute increase of at least 5 mm from nadir. Median PFS was calculated using Kaplan-Meier method and its CI using Brookmeyer-Crowley method.
Timepoint [2] 0 0
Response evaluations performed at screening, q6w ± 1 week from randomization for 48 weeks, and then q9w ± 1 week, starting at Week 48 until PD, up to PCD of 18 March 2024 (maximum of approximately 43.85 months)
Secondary outcome [3] 0 0
Overall Survival (OS) in the Intent-to-Treat Population
Assessment method [3] 0 0
OS was defined as the time from the date of randomization until death due to any cause regardless of whether the participant withdrew from randomized therapy or received another anticancer therapy. Median OS was calculated using Kaplan-Meier method and its CI using Brookmeyer-Crowley method.
Timepoint [3] 0 0
From date of randomization until death due to any cause, up to PCD of 18 March 2024 (maximum of approximately 43.85 months)
Secondary outcome [4] 0 0
Progression-Free Survival Assessed by Investigator in the Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-low Population
Assessment method [4] 0 0
PFS per RECIST 1.1 assessed by Investigator was defined as the time from the date of randomization until the date of PD, as defined or death (by any cause in the absence of progression) regardless of whether the participant withdrew from randomized therapy or received another anticancer therapy prior to progression. PD was defined as at least a 20% increase in the sum of diameters of TLs, taking as reference the smallest previous sum of diameters (nadir), this included the baseline sum if that was the smallest on study. In addition to the relative increase of 20%, the sum must demonstrate an absolute increase of at least 5 mm from nadir. Median PFS was calculated using Kaplan-Meier method and its CI using Brookmeyer-Crowley method.
Timepoint [4] 0 0
Response evaluations performed at screening, q6w ± 1 week from randomization for 48 weeks, and then q9w ± 1 week, starting at Week 48 until PD, up to PCD of 18 March 2024 (maximum of approximately 43.85 months)
Secondary outcome [5] 0 0
Objective Response Rate (ORR) Assessed by Blinded Independent Central Review and Investigator in the Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-low Population
Assessment method [5] 0 0
ORR per RECIST 1.1 assessed by BICR and Investigator was defined as the percentage of participants with at least 1 visit response of complete response (CR) or partial response (PR). CR was defined as disappearance of all TLs since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis diameter to \<10 mm. PR was defined as at least a 30% decrease in the sum of the diameters of TL, taking as reference the baseline sum of diameters.
Timepoint [5] 0 0
Response evaluations performed at screening, q6w ± 1 week from randomization for 48 weeks, and then q9w ± 1 week, starting at Week 48 until PD, up to PCD of 18 March 2024 (maximum of approximately 43.85 months)
Secondary outcome [6] 0 0
Duration of Response (DOR) Assessed by Blinded Independent Central Review and Investigator in the Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-low Population
Assessment method [6] 0 0
DOR per RECIST v1.1 was defined as the time from the date of first documented response until date of documented progression or death in the absence of PD. PD was defined as at least a 20% increase in the sum of diameters of TLs, taking as reference the smallest previous sum of diameters (nadir), this included the baseline sum if that was the smallest on study. In addition to the relative increase of 20%, the sum must demonstrate an absolute increase of at least 5 mm from nadir. Median DOR was calculated using Kaplan-Meier method.
Timepoint [6] 0 0
Response evaluations performed at screening, q6w ± 1 week from randomization for 48 weeks, and then q9w ± 1 week, starting at Week 48 until PD, up to PCD of 18 March 2024 (maximum of approximately 43.85 months)
Secondary outcome [7] 0 0
Objective Response Rate Assessed by Blinded Independent Central Review and Investigator in the Intent-to-Treat and Human Epidermal Growth Factor Receptor 2 Immunohistochemistry >0 <1+ Population
Assessment method [7] 0 0
ORR per RECIST 1.1 assessed by BICR and Investigator was defined as the percentage of participants with at least 1 visit response of CR or PR. CR was defined as disappearance of all TLs since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis diameter to \<10 mm. PR was defined as at least a 30% decrease in the sum of the diameters of TL, taking as reference the baseline sum of diameters.
Timepoint [7] 0 0
Response evaluations performed at screening, q6w ± 1 week from randomization for 48 weeks, and then q9w ± 1 week, starting at Week 48 until PD, up to PCD of 18 March 2024 (maximum of approximately 43.85 months)
Secondary outcome [8] 0 0
Duration of Response Assessed by Blinded Independent Central Review and Investigator in the Intent-to-Treat Population
Assessment method [8] 0 0
DOR per RECIST v1.1 was defined as the time from the date of first documented response until date of documented progression or death in the absence of PD. PD was defined as at least a 20% increase in the sum of diameters of TLs, taking as reference the smallest previous sum of diameters (nadir), this included the baseline sum if that was the smallest on study. In addition to the relative increase of 20%, the sum must demonstrate an absolute increase of at least 5 mm from nadir. Median DOR was calculated using Kaplan-Meier method.
Timepoint [8] 0 0
Response evaluations performed at screening, q6w ± 1 week from randomization for 48 weeks, and then q9w ± 1 week, starting at Week 48 until PD, up to PCD of 18 March 2024 (maximum of approximately 43.85 months)
Secondary outcome [9] 0 0
Time From Randomization to Second Progression or Death (PFS2) in the Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-low and Intent-to-Treat Population
Assessment method [9] 0 0
PFS2 was defined as time from randomization to second progression (the earliest of the progression event subsequent to first subsequent therapy) or death; second progression was defined according to local standard clinical practice and might involve any of the following: objective radiological imaging, symptomatic progression, or death. Median PFS2 was calculated using Kaplan-Meier method and its CI using Brookmeyer-Crowley method.
Timepoint [9] 0 0
Response evaluations performed at screening, q6w ± 1 week from randomization for 48 weeks, and then q9w ± 1 week, starting at Week 48 until PD, up to PCD of 18 March 2024 (maximum of approximately 43.85 months)
Secondary outcome [10] 0 0
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Assessment method [10] 0 0
An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant administered a medicinal product and which did not necessarily had a causal relationship with this treatment. A serious adverse event (SAE) was an AE occurring during any study phase, that fulfilled 1 or more of following criteria: resulted in death, was immediately life-threatening, required in-participant hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability or incapacity, was congenital abnormality or birth defect, and was an important medical event that jeopardized participant or required medical treatment to prevent 1 of outcomes listed above. TEAE was any AE that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after initiation of the study drug until the 40-day (+7 days) safety follow-up visit.
Timepoint [10] 0 0
From first dose of study drug (Day 1) up to PCD of 18 March 2024 (maximum of approximately 43.85 months)
Secondary outcome [11] 0 0
Serum Concentration of Trastuzumab Deruxtecan (T-DXd), Total Anti-Human Epidermal Growth Factor Receptor 2 Antibody and MAAA-1181a
Assessment method [11] 0 0
Blood samples were collected at indicated time points to determine the concentration of T-DXd, total anti-HER2 antibody and MAAA-1181a in serum.
Timepoint [11] 0 0
Pre-dose on Day 1 of Cycles 1, 2, 4, 6 and 8; 15 minutes post-dose on Day 1 of Cycles 1, 2 and 4; and 5 hours post-dose on Day 1 of Cycle 1 (each cycle is 21 days)
Secondary outcome [12] 0 0
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scale Score at Week 91
Assessment method [12] 0 0
EORTC QLQ-C30 is a 30-item self-administered questionnaire grouped into 5 multi-item functional scales(physical,role,emotional,cognitive and social),3 multiitem symptom scales(fatigue,pain and nausea/vomiting),2-item global QoL scale,5 single items assessing additional symptoms reported by cancer participants(dyspnea,loss of appetite,insomnia,constipation and diarrhea). All but 2 questions have 4-point scales:1:not at all,2:a little,3:quite a bit,4:very much.2 questions concerning global health status and QoL have 7-point scales with responses ranging from 1:very poor to 7:excellent;higher score:better level of functioning/greater degree of symptoms.For each of 15 scales,final scores were averaged from scores of component items,transformed,range: 0 to 100;higher scores:better functioning,better health related (HR)QoL,or greater level of symptoms(higher scores:opposite interpretations for functioning/QoL and symptoms/problems).Baseline:last observed measurement prior to randomization.
Timepoint [12] 0 0
Baseline (Day 1) and Week 91
Secondary outcome [13] 0 0
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Breast Module 45 (BR45) Scale Score at Week 58
Assessment method [13] 0 0
EORTC QLQ-BR45 is an updated version of the BR23. Self-administered instrument includes original 23-items yielding 5 multi-item scores (body image, sexual functioning, arm symptoms, breast symptoms, and systemic therapy side effects). Additional 22 items yield 4 additional multi-item scales (breast satisfaction, endocrine therapy symptoms, skin mucosis symptoms, and endocrine sexual symptoms). Single items assess sexual enjoyment, future perspective and being upset by hair loss. Items are scored on a 4-point verbal rating scale: 1: not at all, 2: a little, 3: quite a bit, and 4: very much; higher score: better level of functioning or greater degree of symptoms. Scores of these scales were averaged from scores of component items, transformed, and ranged from 0 to 100; higher scores for functioning scales or items indicate better functioning, whereas higher scores for symptom scales or items represent a higher level of symptoms. Baseline:last observed measurement prior to randomization.
Timepoint [13] 0 0
Baseline (Day 1) and Week 58
Secondary outcome [14] 0 0
Time to Deterioration in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 Scale Score
Assessment method [14] 0 0
Time to deterioration was defined as the time from randomization until the date of the first clinically meaningful deterioration that was confirmed at next available assessment, at least 14 days apart, regardless of whether the participant withdrew from study treatment or receives another anti-cancer therapy prior to deterioration.
Timepoint [14] 0 0
From randomization until date of first symptom deterioration that is confirmed, up to PCD of 18 March 2024 (maximum of approximately 43.85 months)
Secondary outcome [15] 0 0
Number of Participants With Anti-Drug Antibodies (ADAs) Against Trastuzumab Deruxtecan
Assessment method [15] 0 0
Blood samples were collected at indicated timepoints to determine ADA. Treatment-induced ADA was defined as ADA positive post-baseline and not detected at baseline (negative or missing). Treatment-boosted ADA was defined as a baseline positive ADA titer that was boosted to a 4-fold or higher-level following drug administration.
Timepoint [15] 0 0
From Day 1 up to PCD of 18 March 2024 (maximum of approximately 43.85 months)
Secondary outcome [16] 0 0
Time to First Subsequent Treatment or Death (TFST) in the Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-low and Intent-to-Treat Population
Assessment method [16] 0 0
TFST was defined as time from randomization to the start date of the first subsequent anti-cancer therapy after discontinuation of randomized treatment or death due to any cause.
Timepoint [16] 0 0
From Day 1 up to 64 months
Secondary outcome [17] 0 0
Time to Second Subsequent Treatment or Death (TSST) in the Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-low and Intent-to-Treat Population
Assessment method [17] 0 0
TSST was defined as time from randomization to the start date of the second subsequent anti-cancer therapy after discontinuation of randomized treatment or death due to any cause.
Timepoint [17] 0 0
From Day 1 up to 64 months

Eligibility
Key inclusion criteria
Key

* Patients must be =18 years of age
* Pathologically documented breast cancer that:

1. is advanced or metastatic
2. has a history of HER2-low or negative expression by local test, defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) or HER2 IHC 0 (ISH- or untested)
3. has HER2-low or HER2 IHC >0 <1+ expression as determined by the central laboratory result established on a tissue sample taken in the metastatic setting
4. was never previously HER2-positive
5. is documented HR+ disease in the metastatic setting.
* No prior chemotherapy for advanced or metastatic breast cancer.
* Has adequate tumor samples for assessment of HER2 status
* Must have either:

1. disease progression within 6 months of starting first line metastatic treatment with an endocrine therapy combined with a CDK4/6 inhibitor or
2. disease progression on at least 2 previous lines of endocrine therapy with or without a targeted therapy in the metastatic setting. Of note with regards to the =2 lines of previous ET requirement: disease recurrence while on the first 24 months of starting adjuvant ET, will be considered a line of therapy; these patients will only require 1 line of ET in the metastatic setting.
* Has protocol-defined adequate organ and bone marrow function

Key
Minimum age
18 Years
Maximum age
105 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Ineligible for all options in the investigator's choice chemotherapy arm
* Lung-specific intercurrent clinically significant illnesses
* Uncontrolled or significant cardiovascular disease or infection
* Prior documented interstitial lung disease (ILD)/ pneumonitis that required steroids, current ILD/ pneumonitis, or suspected ILD/ pneumonitis that cannot be ruled out by imaging at screening.
* Patients with spinal cord compression or clinically active central nervous system metastases
* Prior randomization or treatment in a previous trastuzumab deruxtecan study regardless of treatment arm assignment
* Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study during the follow up period of a prior interventional study (prescreening for this study while a patient is on treatment in another clinical study is acceptable)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/07/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
19/06/2026
Actual
Sample size
Target
Accrual to date
Final
866
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Adelaide
Recruitment hospital [2] 0 0
Research Site - Birtinya
Recruitment hospital [3] 0 0
Research Site - Darlinghurst
Recruitment hospital [4] 0 0
Research Site - Murdoch
Recruitment hospital [5] 0 0
Research Site - South Brisbane
Recruitment hospital [6] 0 0
Research Site - St Leonards
Recruitment hospital [7] 0 0
Research Site - Waratah
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
4575 - Birtinya
Recruitment postcode(s) [3] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [4] 0 0
6150 - Murdoch
Recruitment postcode(s) [5] 0 0
4101 - South Brisbane
Recruitment postcode(s) [6] 0 0
2065 - St Leonards
Recruitment postcode(s) [7] 0 0
2298 - Waratah
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Minnesota
Country [13] 0 0
United States of America
State/province [13] 0 0
Missouri
Country [14] 0 0
United States of America
State/province [14] 0 0
New Jersey
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
Tennessee
Country [19] 0 0
United States of America
State/province [19] 0 0
Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Virginia
Country [21] 0 0
United States of America
State/province [21] 0 0
Washington
Country [22] 0 0
United States of America
State/province [22] 0 0
Wisconsin
Country [23] 0 0
Argentina
State/province [23] 0 0
Buenos Aires
Country [24] 0 0
Argentina
State/province [24] 0 0
Caba
Country [25] 0 0
Argentina
State/province [25] 0 0
Ciudad de Buenos Aires
Country [26] 0 0
Argentina
State/province [26] 0 0
Cordoba
Country [27] 0 0
Argentina
State/province [27] 0 0
La Plata
Country [28] 0 0
Argentina
State/province [28] 0 0
Mar del Plata
Country [29] 0 0
Argentina
State/province [29] 0 0
Rosario
Country [30] 0 0
Austria
State/province [30] 0 0
Graz
Country [31] 0 0
Austria
State/province [31] 0 0
Innsbruck
Country [32] 0 0
Belgium
State/province [32] 0 0
Anderlecht
Country [33] 0 0
Belgium
State/province [33] 0 0
Bruxelles
Country [34] 0 0
Belgium
State/province [34] 0 0
Charleroi
Country [35] 0 0
Belgium
State/province [35] 0 0
Edegem
Country [36] 0 0
Belgium
State/province [36] 0 0
Gent
Country [37] 0 0
Belgium
State/province [37] 0 0
Leuven
Country [38] 0 0
Belgium
State/province [38] 0 0
Liège
Country [39] 0 0
Belgium
State/province [39] 0 0
Namur
Country [40] 0 0
Belgium
State/province [40] 0 0
Roeselare
Country [41] 0 0
Belgium
State/province [41] 0 0
Sint-Niklaas
Country [42] 0 0
Brazil
State/province [42] 0 0
Barretos
Country [43] 0 0
Brazil
State/province [43] 0 0
Belo Horizonte
Country [44] 0 0
Brazil
State/province [44] 0 0
Natal
Country [45] 0 0
Brazil
State/province [45] 0 0
Porto Alegre
Country [46] 0 0
Brazil
State/province [46] 0 0
Rio de Janeiro
Country [47] 0 0
Brazil
State/province [47] 0 0
Sao Paulo
Country [48] 0 0
Brazil
State/province [48] 0 0
Sorocaba
Country [49] 0 0
Brazil
State/province [49] 0 0
São Paulo
Country [50] 0 0
Canada
State/province [50] 0 0
Alberta
Country [51] 0 0
Canada
State/province [51] 0 0
British Columbia
Country [52] 0 0
Canada
State/province [52] 0 0
CA
Country [53] 0 0
Canada
State/province [53] 0 0
Ontario
Country [54] 0 0
Canada
State/province [54] 0 0
Quebec
Country [55] 0 0
China
State/province [55] 0 0
Baoding
Country [56] 0 0
China
State/province [56] 0 0
Beijing
Country [57] 0 0
China
State/province [57] 0 0
Changchun
Country [58] 0 0
China
State/province [58] 0 0
Changsha
Country [59] 0 0
China
State/province [59] 0 0
Dalian
Country [60] 0 0
China
State/province [60] 0 0
Foshan
Country [61] 0 0
China
State/province [61] 0 0
Fuzhou
Country [62] 0 0
China
State/province [62] 0 0
Guangzhou
Country [63] 0 0
China
State/province [63] 0 0
Hangzhou
Country [64] 0 0
China
State/province [64] 0 0
Harbin
Country [65] 0 0
China
State/province [65] 0 0
Hefei
Country [66] 0 0
China
State/province [66] 0 0
Jinan
Country [67] 0 0
China
State/province [67] 0 0
Linyi
Country [68] 0 0
China
State/province [68] 0 0
Nanchang
Country [69] 0 0
China
State/province [69] 0 0
Nanjing
Country [70] 0 0
China
State/province [70] 0 0
Nanning
Country [71] 0 0
China
State/province [71] 0 0
Shanghai
Country [72] 0 0
China
State/province [72] 0 0
Shenyang
Country [73] 0 0
China
State/province [73] 0 0
Tianjin
Country [74] 0 0
China
State/province [74] 0 0
Urumqi
Country [75] 0 0
China
State/province [75] 0 0
Wuhan
Country [76] 0 0
China
State/province [76] 0 0
Xi'an
Country [77] 0 0
China
State/province [77] 0 0
Zhengzhou
Country [78] 0 0
Denmark
State/province [78] 0 0
Aalborg
Country [79] 0 0
Denmark
State/province [79] 0 0
Copenhagen Ø
Country [80] 0 0
Denmark
State/province [80] 0 0
Odense
Country [81] 0 0
Denmark
State/province [81] 0 0
Vejle
Country [82] 0 0
France
State/province [82] 0 0
Avignon Cedex 09
Country [83] 0 0
France
State/province [83] 0 0
Besançon
Country [84] 0 0
France
State/province [84] 0 0
Bordeaux
Country [85] 0 0
France
State/province [85] 0 0
Brest
Country [86] 0 0
France
State/province [86] 0 0
Caen Cedex 05
Country [87] 0 0
France
State/province [87] 0 0
Dijon
Country [88] 0 0
France
State/province [88] 0 0
Le Mans
Country [89] 0 0
France
State/province [89] 0 0
Marseille
Country [90] 0 0
France
State/province [90] 0 0
Montpellier
Country [91] 0 0
France
State/province [91] 0 0
Nice
Country [92] 0 0
France
State/province [92] 0 0
Paris
Country [93] 0 0
France
State/province [93] 0 0
Pierre Benite
Country [94] 0 0
France
State/province [94] 0 0
Plerin SUR MER
Country [95] 0 0
France
State/province [95] 0 0
Rennes
Country [96] 0 0
France
State/province [96] 0 0
Saint Herblain Cedex
Country [97] 0 0
France
State/province [97] 0 0
Saint-cloud
Country [98] 0 0
France
State/province [98] 0 0
Tours
Country [99] 0 0
France
State/province [99] 0 0
Villejuif Cedex
Country [100] 0 0
Germany
State/province [100] 0 0
Berlin
Country [101] 0 0
Germany
State/province [101] 0 0
Dresden
Country [102] 0 0
Germany
State/province [102] 0 0
Freiburg
Country [103] 0 0
Germany
State/province [103] 0 0
Hannover
Country [104] 0 0
Germany
State/province [104] 0 0
München
Country [105] 0 0
Germany
State/province [105] 0 0
Münster
Country [106] 0 0
Germany
State/province [106] 0 0
Velbert
Country [107] 0 0
Hungary
State/province [107] 0 0
Budapest
Country [108] 0 0
Hungary
State/province [108] 0 0
Gyor
Country [109] 0 0
Hungary
State/province [109] 0 0
Kecskemét
Country [110] 0 0
Hungary
State/province [110] 0 0
Nyíregyháza
Country [111] 0 0
Hungary
State/province [111] 0 0
Szolnok
Country [112] 0 0
Hungary
State/province [112] 0 0
Tatabánya
Country [113] 0 0
India
State/province [113] 0 0
Bengaluru
Country [114] 0 0
India
State/province [114] 0 0
Calicut
Country [115] 0 0
India
State/province [115] 0 0
Kolkata
Country [116] 0 0
India
State/province [116] 0 0
Marg Jaipur
Country [117] 0 0
India
State/province [117] 0 0
New Delhi
Country [118] 0 0
India
State/province [118] 0 0
Surat
Country [119] 0 0
India
State/province [119] 0 0
Thiruvananthapuram
Country [120] 0 0
Israel
State/province [120] 0 0
Haifa
Country [121] 0 0
Israel
State/province [121] 0 0
Jerusalem
Country [122] 0 0
Israel
State/province [122] 0 0
Kfar-Saba
Country [123] 0 0
Israel
State/province [123] 0 0
Petah Tikva
Country [124] 0 0
Israel
State/province [124] 0 0
Ramat Gan
Country [125] 0 0
Israel
State/province [125] 0 0
Tel-Aviv
Country [126] 0 0
Italy
State/province [126] 0 0
Aviano
Country [127] 0 0
Italy
State/province [127] 0 0
Bergamo
Country [128] 0 0
Italy
State/province [128] 0 0
Candiolo
Country [129] 0 0
Italy
State/province [129] 0 0
Cona
Country [130] 0 0
Italy
State/province [130] 0 0
Genova
Country [131] 0 0
Italy
State/province [131] 0 0
Livorno
Country [132] 0 0
Italy
State/province [132] 0 0
Messina
Country [133] 0 0
Italy
State/province [133] 0 0
Milano
Country [134] 0 0
Italy
State/province [134] 0 0
Milan
Country [135] 0 0
Italy
State/province [135] 0 0
Napoli
Country [136] 0 0
Italy
State/province [136] 0 0
Padova
Country [137] 0 0
Italy
State/province [137] 0 0
Parma
Country [138] 0 0
Italy
State/province [138] 0 0
Prato
Country [139] 0 0
Italy
State/province [139] 0 0
Tricase, Lecce
Country [140] 0 0
Italy
State/province [140] 0 0
Udine
Country [141] 0 0
Japan
State/province [141] 0 0
Akashi-shi
Country [142] 0 0
Japan
State/province [142] 0 0
Bunkyo-ku
Country [143] 0 0
Japan
State/province [143] 0 0
Chiba-shi
Country [144] 0 0
Japan
State/province [144] 0 0
Chuo-ku
Country [145] 0 0
Japan
State/province [145] 0 0
Fukuoka-shi
Country [146] 0 0
Japan
State/province [146] 0 0
Gifu-shi
Country [147] 0 0
Japan
State/province [147] 0 0
Hidaka-shi
Country [148] 0 0
Japan
State/province [148] 0 0
Hiroshima-shi
Country [149] 0 0
Japan
State/province [149] 0 0
Isehara
Country [150] 0 0
Japan
State/province [150] 0 0
Kagoshima-shi
Country [151] 0 0
Japan
State/province [151] 0 0
Kashiwa
Country [152] 0 0
Japan
State/province [152] 0 0
Kawasaki-shi
Country [153] 0 0
Japan
State/province [153] 0 0
Kitaadachi-gun
Country [154] 0 0
Japan
State/province [154] 0 0
Koto-ku
Country [155] 0 0
Japan
State/province [155] 0 0
Matsuyama-shi
Country [156] 0 0
Japan
State/province [156] 0 0
Nagoya
Country [157] 0 0
Japan
State/province [157] 0 0
Naha-shi
Country [158] 0 0
Japan
State/province [158] 0 0
Niigata-shi
Country [159] 0 0
Japan
State/province [159] 0 0
Nishinomiya-shi
Country [160] 0 0
Japan
State/province [160] 0 0
Okayama-shi
Country [161] 0 0
Japan
State/province [161] 0 0
Osaka-shi
Country [162] 0 0
Japan
State/province [162] 0 0
Osakasayama-shi
Country [163] 0 0
Japan
State/province [163] 0 0
Sagamihara-shi
Country [164] 0 0
Japan
State/province [164] 0 0
Sapporo-shi
Country [165] 0 0
Japan
State/province [165] 0 0
Shinagawa-ku
Country [166] 0 0
Japan
State/province [166] 0 0
Shinjuku-ku
Country [167] 0 0
Japan
State/province [167] 0 0
Shizuoka
Country [168] 0 0
Japan
State/province [168] 0 0
Tsu-shi
Country [169] 0 0
Japan
State/province [169] 0 0
Yokohama-shi
Country [170] 0 0
Korea, Republic of
State/province [170] 0 0
Daegu
Country [171] 0 0
Korea, Republic of
State/province [171] 0 0
Goyang-si
Country [172] 0 0
Korea, Republic of
State/province [172] 0 0
Incheon
Country [173] 0 0
Korea, Republic of
State/province [173] 0 0
Seongnam-si
Country [174] 0 0
Korea, Republic of
State/province [174] 0 0
Seoul
Country [175] 0 0
Mexico
State/province [175] 0 0
Alc. Cuauhtémoc
Country [176] 0 0
Mexico
State/province [176] 0 0
Guadalajara Jalisco
Country [177] 0 0
Mexico
State/province [177] 0 0
Guadalajra
Country [178] 0 0
Mexico
State/province [178] 0 0
Mexico City
Country [179] 0 0
Mexico
State/province [179] 0 0
Mexico, D.F.
Country [180] 0 0
Mexico
State/province [180] 0 0
Monterrey
Country [181] 0 0
Mexico
State/province [181] 0 0
México
Country [182] 0 0
Mexico
State/province [182] 0 0
Nuevo Leon
Country [183] 0 0
Netherlands
State/province [183] 0 0
Amsterdam
Country [184] 0 0
Netherlands
State/province [184] 0 0
Breda
Country [185] 0 0
Netherlands
State/province [185] 0 0
Hengelo
Country [186] 0 0
Netherlands
State/province [186] 0 0
Leeuwarden
Country [187] 0 0
Netherlands
State/province [187] 0 0
Rotterdam
Country [188] 0 0
Netherlands
State/province [188] 0 0
Sittard-Geleen
Country [189] 0 0
Poland
State/province [189] 0 0
Bydgoszcz
Country [190] 0 0
Poland
State/province [190] 0 0
Koszalin
Country [191] 0 0
Poland
State/province [191] 0 0
Kraków
Country [192] 0 0
Poland
State/province [192] 0 0
Rzeszów
Country [193] 0 0
Poland
State/province [193] 0 0
Warszawa
Country [194] 0 0
Poland
State/province [194] 0 0
Wroclaw
Country [195] 0 0
Poland
State/province [195] 0 0
Lódz
Country [196] 0 0
Portugal
State/province [196] 0 0
Lisboa
Country [197] 0 0
Russian Federation
State/province [197] 0 0
Krasnodar
Country [198] 0 0
Russian Federation
State/province [198] 0 0
Moscow
Country [199] 0 0
Russian Federation
State/province [199] 0 0
Saint Petersburg
Country [200] 0 0
Russian Federation
State/province [200] 0 0
Saint-Petersburg
Country [201] 0 0
Russian Federation
State/province [201] 0 0
Sankt-Peterburg
Country [202] 0 0
Russian Federation
State/province [202] 0 0
Yaroslavl
Country [203] 0 0
Saudi Arabia
State/province [203] 0 0
Ar Riya?
Country [204] 0 0
Saudi Arabia
State/province [204] 0 0
Dammam
Country [205] 0 0
Saudi Arabia
State/province [205] 0 0
Jeddah
Country [206] 0 0
Saudi Arabia
State/province [206] 0 0
Riyadh
Country [207] 0 0
Singapore
State/province [207] 0 0
Bukit Merah
Country [208] 0 0
Singapore
State/province [208] 0 0
Singapore
Country [209] 0 0
Spain
State/province [209] 0 0
Barcelona
Country [210] 0 0
Spain
State/province [210] 0 0
Cordoba
Country [211] 0 0
Spain
State/province [211] 0 0
El Palmar
Country [212] 0 0
Spain
State/province [212] 0 0
La Coruña
Country [213] 0 0
Spain
State/province [213] 0 0
Madrid
Country [214] 0 0
Spain
State/province [214] 0 0
San Sebastián
Country [215] 0 0
Spain
State/province [215] 0 0
Sevilla
Country [216] 0 0
Spain
State/province [216] 0 0
Valencia
Country [217] 0 0
Sweden
State/province [217] 0 0
Göteborg
Country [218] 0 0
Sweden
State/province [218] 0 0
Stockholm
Country [219] 0 0
Sweden
State/province [219] 0 0
Uppsala
Country [220] 0 0
Sweden
State/province [220] 0 0
Växjö
Country [221] 0 0
Sweden
State/province [221] 0 0
Örebro
Country [222] 0 0
Taiwan
State/province [222] 0 0
Taichung
Country [223] 0 0
Taiwan
State/province [223] 0 0
Tainan
Country [224] 0 0
Taiwan
State/province [224] 0 0
Taipei
Country [225] 0 0
Taiwan
State/province [225] 0 0
Tao-Yuan
Country [226] 0 0
United Kingdom
State/province [226] 0 0
Cambridge
Country [227] 0 0
United Kingdom
State/province [227] 0 0
Cardiff
Country [228] 0 0
United Kingdom
State/province [228] 0 0
Edinburgh
Country [229] 0 0
United Kingdom
State/province [229] 0 0
Guildford
Country [230] 0 0
United Kingdom
State/province [230] 0 0
Leeds
Country [231] 0 0
United Kingdom
State/province [231] 0 0
London
Country [232] 0 0
United Kingdom
State/province [232] 0 0
Manchester
Country [233] 0 0
United Kingdom
State/province [233] 0 0
Northwood

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Daiichi Sankyo Company, Limited 3-5-1 Nihonbashihoncho, Chuo-ku, Tokyo
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

TypeOther DetailsAttachment
Study protocol
Statistical analysis plan



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04494425