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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
Date last updated
18/06/2025
Titles & IDs
Public title
Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer
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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)
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Secondary ID [1]
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2023-505554-18-00
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Secondary ID [2]
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D9670C00001
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Universal Trial Number (UTN)
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Trial acronym
DB-06
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced or 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 - 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
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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) Assessed by Blinded Independent Central Review (BICR) in the Hormone Receptor-Positive (HR+), Human Epidermal Growth Factor Receptor 2 (HER2)-Low Population
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Assessment method [1]
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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.
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Timepoint [1]
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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)
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Secondary outcome [1]
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Overall Survival (OS) in the Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-low Population
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Assessment method [1]
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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.
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Timepoint [1]
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From date of randomization until death due to any cause, up to PCD of 18 March 2024 (maximum of approximately 43.85 months)
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Secondary outcome [2]
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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
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Assessment method [2]
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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.
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Timepoint [2]
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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)
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Secondary outcome [3]
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Overall Survival (OS) in the Intent-to-Treat Population
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Assessment method [3]
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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.
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Timepoint [3]
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From date of randomization until death due to any cause, up to PCD of 18 March 2024 (maximum of approximately 43.85 months)
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Secondary outcome [4]
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Progression-Free Survival Assessed by Investigator in the Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-low Population
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Assessment method [4]
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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.
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Timepoint [4]
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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)
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Secondary outcome [5]
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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
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Assessment method [5]
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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.
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Timepoint [5]
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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)
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Secondary outcome [6]
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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
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Assessment method [6]
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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.
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Timepoint [6]
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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)
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Secondary outcome [7]
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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
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Assessment method [7]
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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.
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Timepoint [7]
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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)
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Secondary outcome [8]
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Duration of Response Assessed by Blinded Independent Central Review and Investigator in the Intent-to-Treat Population
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Assessment method [8]
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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.
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Timepoint [8]
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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)
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Secondary outcome [9]
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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
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Assessment method [9]
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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.
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Timepoint [9]
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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)
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Secondary outcome [10]
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Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
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Assessment method [10]
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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.
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Timepoint [10]
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From first dose of study drug (Day 1) up to PCD of 18 March 2024 (maximum of approximately 43.85 months)
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Secondary outcome [11]
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Serum Concentration of Trastuzumab Deruxtecan (T-DXd), Total Anti-Human Epidermal Growth Factor Receptor 2 Antibody and MAAA-1181a
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Assessment method [11]
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Blood samples were collected at indicated time points to determine the concentration of T-DXd, total anti-HER2 antibody and MAAA-1181a in serum.
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Timepoint [11]
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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)
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Secondary outcome [12]
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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
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Assessment method [12]
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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.
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Timepoint [12]
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Baseline (Day 1) and Week 91
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Secondary outcome [13]
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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
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Assessment method [13]
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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.
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Timepoint [13]
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Baseline (Day 1) and Week 58
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Secondary outcome [14]
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Time to Deterioration in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 Scale Score
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Assessment method [14]
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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.
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Timepoint [14]
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From randomization until date of first symptom deterioration that is confirmed, up to PCD of 18 March 2024 (maximum of approximately 43.85 months)
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Secondary outcome [15]
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Number of Participants With Anti-Drug Antibodies (ADAs) Against Trastuzumab Deruxtecan
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Assessment method [15]
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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.
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Timepoint [15]
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From Day 1 up to PCD of 18 March 2024 (maximum of approximately 43.85 months)
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Secondary outcome [16]
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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
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Assessment method [16]
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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.
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Timepoint [16]
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From Day 1 up to 64 months
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Secondary outcome [17]
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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
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Assessment method [17]
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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.
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Timepoint [17]
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From Day 1 up to 64 months
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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
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Minimum age
18
Years
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Maximum age
105
Years
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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
* 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)
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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
Active, not 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
24/07/2020
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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
19/06/2026
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Actual
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Sample size
Target
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Accrual to date
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Final
866
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Adelaide
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Recruitment hospital [2]
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Research Site - Birtinya
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Recruitment hospital [3]
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Research Site - Darlinghurst
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Recruitment hospital [4]
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Research Site - Murdoch
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Recruitment hospital [5]
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Research Site - South Brisbane
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Recruitment hospital [6]
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Research Site - St Leonards
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Recruitment hospital [7]
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Research Site - Waratah
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment postcode(s) [2]
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4575 - Birtinya
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Recruitment postcode(s) [3]
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2010 - Darlinghurst
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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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4101 - South Brisbane
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Recruitment postcode(s) [6]
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2065 - St Leonards
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Recruitment postcode(s) [7]
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2298 - Waratah
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Recruitment outside Australia
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United States of America
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Arizona
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Arkansas
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California
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Colorado
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District of Columbia
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Florida
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Kansas
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Kentucky
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Missouri
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New York
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Ohio
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Tennessee
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Texas
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Caba
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Argentina
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Ciudad de Buenos Aires
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Argentina
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Cordoba
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Argentina
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La Plata
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Argentina
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Mar del Plata
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Argentina
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Rosario
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Austria
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Graz
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Austria
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Innsbruck
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Belgium
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Anderlecht
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Bruxelles
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Charleroi
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Edegem
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Gent
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Leuven
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Liège
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Namur
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Belgium
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State/province [40]
0
0
Roeselare
Query!
Country [41]
0
0
Belgium
Query!
State/province [41]
0
0
Sint-Niklaas
Query!
Country [42]
0
0
Brazil
Query!
State/province [42]
0
0
Barretos
Query!
Country [43]
0
0
Brazil
Query!
State/province [43]
0
0
Belo Horizonte
Query!
Country [44]
0
0
Brazil
Query!
State/province [44]
0
0
Natal
Query!
Country [45]
0
0
Brazil
Query!
State/province [45]
0
0
Porto Alegre
Query!
Country [46]
0
0
Brazil
Query!
State/province [46]
0
0
Rio de Janeiro
Query!
Country [47]
0
0
Brazil
Query!
State/province [47]
0
0
Sao Paulo
Query!
Country [48]
0
0
Brazil
Query!
State/province [48]
0
0
Sorocaba
Query!
Country [49]
0
0
Brazil
Query!
State/province [49]
0
0
São Paulo
Query!
Country [50]
0
0
Canada
Query!
State/province [50]
0
0
Alberta
Query!
Country [51]
0
0
Canada
Query!
State/province [51]
0
0
British Columbia
Query!
Country [52]
0
0
Canada
Query!
State/province [52]
0
0
CA
Query!
Country [53]
0
0
Canada
Query!
State/province [53]
0
0
Ontario
Query!
Country [54]
0
0
Canada
Query!
State/province [54]
0
0
Quebec
Query!
Country [55]
0
0
China
Query!
State/province [55]
0
0
Baoding
Query!
Country [56]
0
0
China
Query!
State/province [56]
0
0
Beijing
Query!
Country [57]
0
0
China
Query!
State/province [57]
0
0
Changchun
Query!
Country [58]
0
0
China
Query!
State/province [58]
0
0
Changsha
Query!
Country [59]
0
0
China
Query!
State/province [59]
0
0
Dalian
Query!
Country [60]
0
0
China
Query!
State/province [60]
0
0
Foshan
Query!
Country [61]
0
0
China
Query!
State/province [61]
0
0
Fuzhou
Query!
Country [62]
0
0
China
Query!
State/province [62]
0
0
Guangzhou
Query!
Country [63]
0
0
China
Query!
State/province [63]
0
0
Hangzhou
Query!
Country [64]
0
0
China
Query!
State/province [64]
0
0
Harbin
Query!
Country [65]
0
0
China
Query!
State/province [65]
0
0
Hefei
Query!
Country [66]
0
0
China
Query!
State/province [66]
0
0
Jinan
Query!
Country [67]
0
0
China
Query!
State/province [67]
0
0
Linyi
Query!
Country [68]
0
0
China
Query!
State/province [68]
0
0
Nanchang
Query!
Country [69]
0
0
China
Query!
State/province [69]
0
0
Nanjing
Query!
Country [70]
0
0
China
Query!
State/province [70]
0
0
Nanning
Query!
Country [71]
0
0
China
Query!
State/province [71]
0
0
Shanghai
Query!
Country [72]
0
0
China
Query!
State/province [72]
0
0
Shenyang
Query!
Country [73]
0
0
China
Query!
State/province [73]
0
0
Tianjin
Query!
Country [74]
0
0
China
Query!
State/province [74]
0
0
Urumqi
Query!
Country [75]
0
0
China
Query!
State/province [75]
0
0
Wuhan
Query!
Country [76]
0
0
China
Query!
State/province [76]
0
0
Xi'an
Query!
Country [77]
0
0
China
Query!
State/province [77]
0
0
Zhengzhou
Query!
Country [78]
0
0
Denmark
Query!
State/province [78]
0
0
Aalborg
Query!
Country [79]
0
0
Denmark
Query!
State/province [79]
0
0
Copenhagen Ø
Query!
Country [80]
0
0
Denmark
Query!
State/province [80]
0
0
Odense
Query!
Country [81]
0
0
Denmark
Query!
State/province [81]
0
0
Vejle
Query!
Country [82]
0
0
France
Query!
State/province [82]
0
0
Avignon Cedex 09
Query!
Country [83]
0
0
France
Query!
State/province [83]
0
0
Besançon
Query!
Country [84]
0
0
France
Query!
State/province [84]
0
0
Bordeaux
Query!
Country [85]
0
0
France
Query!
State/province [85]
0
0
Brest
Query!
Country [86]
0
0
France
Query!
State/province [86]
0
0
Caen Cedex 05
Query!
Country [87]
0
0
France
Query!
State/province [87]
0
0
Dijon
Query!
Country [88]
0
0
France
Query!
State/province [88]
0
0
Le Mans
Query!
Country [89]
0
0
France
Query!
State/province [89]
0
0
Marseille
Query!
Country [90]
0
0
France
Query!
State/province [90]
0
0
Montpellier
Query!
Country [91]
0
0
France
Query!
State/province [91]
0
0
Nice
Query!
Country [92]
0
0
France
Query!
State/province [92]
0
0
Paris
Query!
Country [93]
0
0
France
Query!
State/province [93]
0
0
Pierre Benite
Query!
Country [94]
0
0
France
Query!
State/province [94]
0
0
Plerin SUR MER
Query!
Country [95]
0
0
France
Query!
State/province [95]
0
0
Rennes
Query!
Country [96]
0
0
France
Query!
State/province [96]
0
0
Saint Herblain Cedex
Query!
Country [97]
0
0
France
Query!
State/province [97]
0
0
Saint-cloud
Query!
Country [98]
0
0
France
Query!
State/province [98]
0
0
Tours
Query!
Country [99]
0
0
France
Query!
State/province [99]
0
0
Villejuif Cedex
Query!
Country [100]
0
0
Germany
Query!
State/province [100]
0
0
Berlin
Query!
Country [101]
0
0
Germany
Query!
State/province [101]
0
0
Dresden
Query!
Country [102]
0
0
Germany
Query!
State/province [102]
0
0
Freiburg
Query!
Country [103]
0
0
Germany
Query!
State/province [103]
0
0
Hannover
Query!
Country [104]
0
0
Germany
Query!
State/province [104]
0
0
München
Query!
Country [105]
0
0
Germany
Query!
State/province [105]
0
0
Münster
Query!
Country [106]
0
0
Germany
Query!
State/province [106]
0
0
Velbert
Query!
Country [107]
0
0
Hungary
Query!
State/province [107]
0
0
Budapest
Query!
Country [108]
0
0
Hungary
Query!
State/province [108]
0
0
Gyor
Query!
Country [109]
0
0
Hungary
Query!
State/province [109]
0
0
Kecskemét
Query!
Country [110]
0
0
Hungary
Query!
State/province [110]
0
0
Nyíregyháza
Query!
Country [111]
0
0
Hungary
Query!
State/province [111]
0
0
Szolnok
Query!
Country [112]
0
0
Hungary
Query!
State/province [112]
0
0
Tatabánya
Query!
Country [113]
0
0
India
Query!
State/province [113]
0
0
Bengaluru
Query!
Country [114]
0
0
India
Query!
State/province [114]
0
0
Calicut
Query!
Country [115]
0
0
India
Query!
State/province [115]
0
0
Kolkata
Query!
Country [116]
0
0
India
Query!
State/province [116]
0
0
Marg Jaipur
Query!
Country [117]
0
0
India
Query!
State/province [117]
0
0
New Delhi
Query!
Country [118]
0
0
India
Query!
State/province [118]
0
0
Surat
Query!
Country [119]
0
0
India
Query!
State/province [119]
0
0
Thiruvananthapuram
Query!
Country [120]
0
0
Israel
Query!
State/province [120]
0
0
Haifa
Query!
Country [121]
0
0
Israel
Query!
State/province [121]
0
0
Jerusalem
Query!
Country [122]
0
0
Israel
Query!
State/province [122]
0
0
Kfar-Saba
Query!
Country [123]
0
0
Israel
Query!
State/province [123]
0
0
Petah Tikva
Query!
Country [124]
0
0
Israel
Query!
State/province [124]
0
0
Ramat Gan
Query!
Country [125]
0
0
Israel
Query!
State/province [125]
0
0
Tel-Aviv
Query!
Country [126]
0
0
Italy
Query!
State/province [126]
0
0
Aviano
Query!
Country [127]
0
0
Italy
Query!
State/province [127]
0
0
Bergamo
Query!
Country [128]
0
0
Italy
Query!
State/province [128]
0
0
Candiolo
Query!
Country [129]
0
0
Italy
Query!
State/province [129]
0
0
Cona
Query!
Country [130]
0
0
Italy
Query!
State/province [130]
0
0
Genova
Query!
Country [131]
0
0
Italy
Query!
State/province [131]
0
0
Livorno
Query!
Country [132]
0
0
Italy
Query!
State/province [132]
0
0
Messina
Query!
Country [133]
0
0
Italy
Query!
State/province [133]
0
0
Milano
Query!
Country [134]
0
0
Italy
Query!
State/province [134]
0
0
Milan
Query!
Country [135]
0
0
Italy
Query!
State/province [135]
0
0
Napoli
Query!
Country [136]
0
0
Italy
Query!
State/province [136]
0
0
Padova
Query!
Country [137]
0
0
Italy
Query!
State/province [137]
0
0
Parma
Query!
Country [138]
0
0
Italy
Query!
State/province [138]
0
0
Prato
Query!
Country [139]
0
0
Italy
Query!
State/province [139]
0
0
Tricase, Lecce
Query!
Country [140]
0
0
Italy
Query!
State/province [140]
0
0
Udine
Query!
Country [141]
0
0
Japan
Query!
State/province [141]
0
0
Akashi-shi
Query!
Country [142]
0
0
Japan
Query!
State/province [142]
0
0
Bunkyo-ku
Query!
Country [143]
0
0
Japan
Query!
State/province [143]
0
0
Chiba-shi
Query!
Country [144]
0
0
Japan
Query!
State/province [144]
0
0
Chuo-ku
Query!
Country [145]
0
0
Japan
Query!
State/province [145]
0
0
Fukuoka-shi
Query!
Country [146]
0
0
Japan
Query!
State/province [146]
0
0
Gifu-shi
Query!
Country [147]
0
0
Japan
Query!
State/province [147]
0
0
Hidaka-shi
Query!
Country [148]
0
0
Japan
Query!
State/province [148]
0
0
Hiroshima-shi
Query!
Country [149]
0
0
Japan
Query!
State/province [149]
0
0
Isehara
Query!
Country [150]
0
0
Japan
Query!
State/province [150]
0
0
Kagoshima-shi
Query!
Country [151]
0
0
Japan
Query!
State/province [151]
0
0
Kashiwa
Query!
Country [152]
0
0
Japan
Query!
State/province [152]
0
0
Kawasaki-shi
Query!
Country [153]
0
0
Japan
Query!
State/province [153]
0
0
Kitaadachi-gun
Query!
Country [154]
0
0
Japan
Query!
State/province [154]
0
0
Koto-ku
Query!
Country [155]
0
0
Japan
Query!
State/province [155]
0
0
Matsuyama-shi
Query!
Country [156]
0
0
Japan
Query!
State/province [156]
0
0
Nagoya
Query!
Country [157]
0
0
Japan
Query!
State/province [157]
0
0
Naha-shi
Query!
Country [158]
0
0
Japan
Query!
State/province [158]
0
0
Niigata-shi
Query!
Country [159]
0
0
Japan
Query!
State/province [159]
0
0
Nishinomiya-shi
Query!
Country [160]
0
0
Japan
Query!
State/province [160]
0
0
Okayama-shi
Query!
Country [161]
0
0
Japan
Query!
State/province [161]
0
0
Osaka-shi
Query!
Country [162]
0
0
Japan
Query!
State/province [162]
0
0
Osakasayama-shi
Query!
Country [163]
0
0
Japan
Query!
State/province [163]
0
0
Sagamihara-shi
Query!
Country [164]
0
0
Japan
Query!
State/province [164]
0
0
Sapporo-shi
Query!
Country [165]
0
0
Japan
Query!
State/province [165]
0
0
Shinagawa-ku
Query!
Country [166]
0
0
Japan
Query!
State/province [166]
0
0
Shinjuku-ku
Query!
Country [167]
0
0
Japan
Query!
State/province [167]
0
0
Shizuoka
Query!
Country [168]
0
0
Japan
Query!
State/province [168]
0
0
Tsu-shi
Query!
Country [169]
0
0
Japan
Query!
State/province [169]
0
0
Yokohama-shi
Query!
Country [170]
0
0
Korea, Republic of
Query!
State/province [170]
0
0
Daegu
Query!
Country [171]
0
0
Korea, Republic of
Query!
State/province [171]
0
0
Goyang-si
Query!
Country [172]
0
0
Korea, Republic of
Query!
State/province [172]
0
0
Incheon
Query!
Country [173]
0
0
Korea, Republic of
Query!
State/province [173]
0
0
Seongnam-si
Query!
Country [174]
0
0
Korea, Republic of
Query!
State/province [174]
0
0
Seoul
Query!
Country [175]
0
0
Mexico
Query!
State/province [175]
0
0
Alc. Cuauhtémoc
Query!
Country [176]
0
0
Mexico
Query!
State/province [176]
0
0
Guadalajara Jalisco
Query!
Country [177]
0
0
Mexico
Query!
State/province [177]
0
0
Guadalajra
Query!
Country [178]
0
0
Mexico
Query!
State/province [178]
0
0
Mexico City
Query!
Country [179]
0
0
Mexico
Query!
State/province [179]
0
0
Mexico, D.F.
Query!
Country [180]
0
0
Mexico
Query!
State/province [180]
0
0
Monterrey
Query!
Country [181]
0
0
Mexico
Query!
State/province [181]
0
0
México
Query!
Country [182]
0
0
Mexico
Query!
State/province [182]
0
0
Nuevo Leon
Query!
Country [183]
0
0
Netherlands
Query!
State/province [183]
0
0
Amsterdam
Query!
Country [184]
0
0
Netherlands
Query!
State/province [184]
0
0
Breda
Query!
Country [185]
0
0
Netherlands
Query!
State/province [185]
0
0
Hengelo
Query!
Country [186]
0
0
Netherlands
Query!
State/province [186]
0
0
Leeuwarden
Query!
Country [187]
0
0
Netherlands
Query!
State/province [187]
0
0
Rotterdam
Query!
Country [188]
0
0
Netherlands
Query!
State/province [188]
0
0
Sittard-Geleen
Query!
Country [189]
0
0
Poland
Query!
State/province [189]
0
0
Bydgoszcz
Query!
Country [190]
0
0
Poland
Query!
State/province [190]
0
0
Koszalin
Query!
Country [191]
0
0
Poland
Query!
State/province [191]
0
0
Kraków
Query!
Country [192]
0
0
Poland
Query!
State/province [192]
0
0
Rzeszów
Query!
Country [193]
0
0
Poland
Query!
State/province [193]
0
0
Warszawa
Query!
Country [194]
0
0
Poland
Query!
State/province [194]
0
0
Wroclaw
Query!
Country [195]
0
0
Poland
Query!
State/province [195]
0
0
Lódz
Query!
Country [196]
0
0
Portugal
Query!
State/province [196]
0
0
Lisboa
Query!
Country [197]
0
0
Russian Federation
Query!
State/province [197]
0
0
Krasnodar
Query!
Country [198]
0
0
Russian Federation
Query!
State/province [198]
0
0
Moscow
Query!
Country [199]
0
0
Russian Federation
Query!
State/province [199]
0
0
Saint Petersburg
Query!
Country [200]
0
0
Russian Federation
Query!
State/province [200]
0
0
Saint-Petersburg
Query!
Country [201]
0
0
Russian Federation
Query!
State/province [201]
0
0
Sankt-Peterburg
Query!
Country [202]
0
0
Russian Federation
Query!
State/province [202]
0
0
Yaroslavl
Query!
Country [203]
0
0
Saudi Arabia
Query!
State/province [203]
0
0
Ar Riya?
Query!
Country [204]
0
0
Saudi Arabia
Query!
State/province [204]
0
0
Dammam
Query!
Country [205]
0
0
Saudi Arabia
Query!
State/province [205]
0
0
Jeddah
Query!
Country [206]
0
0
Saudi Arabia
Query!
State/province [206]
0
0
Riyadh
Query!
Country [207]
0
0
Singapore
Query!
State/province [207]
0
0
Bukit Merah
Query!
Country [208]
0
0
Singapore
Query!
State/province [208]
0
0
Singapore
Query!
Country [209]
0
0
Spain
Query!
State/province [209]
0
0
Barcelona
Query!
Country [210]
0
0
Spain
Query!
State/province [210]
0
0
Cordoba
Query!
Country [211]
0
0
Spain
Query!
State/province [211]
0
0
El Palmar
Query!
Country [212]
0
0
Spain
Query!
State/province [212]
0
0
La Coruña
Query!
Country [213]
0
0
Spain
Query!
State/province [213]
0
0
Madrid
Query!
Country [214]
0
0
Spain
Query!
State/province [214]
0
0
San Sebastián
Query!
Country [215]
0
0
Spain
Query!
State/province [215]
0
0
Sevilla
Query!
Country [216]
0
0
Spain
Query!
State/province [216]
0
0
Valencia
Query!
Country [217]
0
0
Sweden
Query!
State/province [217]
0
0
Göteborg
Query!
Country [218]
0
0
Sweden
Query!
State/province [218]
0
0
Stockholm
Query!
Country [219]
0
0
Sweden
Query!
State/province [219]
0
0
Uppsala
Query!
Country [220]
0
0
Sweden
Query!
State/province [220]
0
0
Växjö
Query!
Country [221]
0
0
Sweden
Query!
State/province [221]
0
0
Örebro
Query!
Country [222]
0
0
Taiwan
Query!
State/province [222]
0
0
Taichung
Query!
Country [223]
0
0
Taiwan
Query!
State/province [223]
0
0
Tainan
Query!
Country [224]
0
0
Taiwan
Query!
State/province [224]
0
0
Taipei
Query!
Country [225]
0
0
Taiwan
Query!
State/province [225]
0
0
Tao-Yuan
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Country [226]
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United Kingdom
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Cambridge
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Cardiff
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Edinburgh
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Guildford
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Leeds
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London
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Manchester
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United Kingdom
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Northwood
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Other
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Daiichi Sankyo Company, Limited 3-5-1 Nihonbashihoncho, Chuo-ku, Tokyo
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Ethics approval
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Summary
Brief summary
This study will evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan compared with investigator's choice chemotherapy in human epidermal growth factor receptor (HER)2-low, hormone receptor (HR) positive breast cancer patients whose disease has progressed on endocrine therapy in the metastatic setting.
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Trial website
https://clinicaltrials.gov/study/NCT04494425
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Contacts
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
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When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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Available to whom?
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home
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What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/25/NCT04494425/Prot_002.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/25/NCT04494425/SAP_003.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT04494425
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