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DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03]

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ClinicalTrials.gov Identifier: NCT03529110
Recruitment Status : Active, not recruiting
First Posted : May 18, 2018
Results First Posted : April 29, 2022
Last Update Posted : April 18, 2024
Sponsor:
Collaborators:
Daiichi Sankyo Co., Ltd.
AstraZeneca
Information provided by (Responsible Party):
Daiichi Sankyo

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: Trastuzumab deruxtecan (T-DXd)
Drug: Ado-trastuzumab emtansine (T-DM1)
Enrollment 524
Recruitment Details A total of 524 participants were enrolled and treated at study sites in 14 countries. Primary results reported is from first participant randomized up to data cut-off date of 21 May 2021. The results presented are based on primary analysis up to 33 months. Data collection is still on-going and additional results will be provided after study completion.
Pre-assignment Details  
Arm/Group Title Trastuzumab Deruxtecan (T-DXd) Ado-trastuzumab Emtansine (T-DM1)
Hide Arm/Group Description Participants with HER2-positive, unresectable and/or metastatic breast cancer participants previously treated with trastuzumab and taxane who received T-DXd as a sterile intravenous (IV) solution at a dose of 5.4 mg/kg every 3 weeks (Q3W). Participants with HER2-positive, unresectable and/or metastatic breast cancer participants previously treated with trastuzumab and taxane who received T-DM1 in accordance with the approved label.
Period Title: Overall Study
Started 261 263
Completed 136 49
Not Completed 125 214
Reason Not Completed
Progressive Disease             66             158
Clinical Progression             4             12
Adverse Event             35             17
Withdrawal by Subject (from treatment only)             13             11
Lack of Efficacy             3             3
Physician Decision             2             8
Miscellaneous             2             5
Arm/Group Title Trastuzumab Deruxtecan (T-DXd) Ado-trastuzumab Emtansine (T-DM1) Total
Hide Arm/Group Description Participants with HER2-positive, unresectable and/or metastatic breast cancer participants previously treated with trastuzumab and taxane who received T-DXd as a sterile intravenous (IV) solution at a dose of 5.4 mg/kg every 3 weeks (Q3W). Participants with HER2-positive, unresectable and/or metastatic breast cancer participants previously treated with trastuzumab and taxane who received T-DM1 in accordance with the approved label. Total of all reporting groups
Overall Number of Baseline Participants 261 263 524
Hide Baseline Analysis Population Description
Baseline characteristics were assessed using the Full Analysis Set.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 261 participants 263 participants 524 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
212
  81.2%
206
  78.3%
418
  79.8%
>=65 years
49
  18.8%
57
  21.7%
106
  20.2%
Age, Continuous  
Median (Standard Deviation)
Unit of measure:  Years
Number Analyzed 261 participants 263 participants 524 participants
54.5  (11.11) 54.2  (11.84) 54.4  (11.47)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 261 participants 263 participants 524 participants
Female
260
  99.6%
262
  99.6%
522
  99.6%
Male
1
   0.4%
1
   0.4%
2
   0.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 261 participants 263 participants 524 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
152
  58.2%
162
  61.6%
314
  59.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
10
   3.8%
9
   3.4%
19
   3.6%
White
71
  27.2%
72
  27.4%
143
  27.3%
More than one race
2
   0.8%
0
   0.0%
2
   0.4%
Unknown or Not Reported
26
  10.0%
20
   7.6%
46
   8.8%
1.Primary Outcome
Title Progression-Free Survival (PFS) Based on Blinded Independent Central Review (BICR) in Participants With HER2-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane
Hide Description Progression-free survival (PFS) by BICR was defined as the time from the date of enrollment to the earlier of the dates of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions.
Time Frame Up to 33 months (data cut-off)
Hide Outcome Measure Data
Hide Analysis Population Description
Progression-free survival (PFS) was assessed in the Full Analysis Set at data cut-off date of 21 May 2021.
Arm/Group Title Trastuzumab Deruxtecan (T-DXd) Ado-trastuzumab Emtansine (T-DM1)
Hide Arm/Group Description:
Participants with HER2-positive, unresectable and/or metastatic breast cancer participants previously treated with trastuzumab and taxane who received T-DXd as a sterile intravenous (IV) solution at a dose of 5.4 mg/kg every 3 weeks (Q3W).
Participants with HER2-positive, unresectable and/or metastatic breast cancer participants previously treated with trastuzumab and taxane who received T-DM1 in accordance with the approved label.
Overall Number of Participants Analyzed 261 263
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(18.5 to NA)
6.8
(5.6 to 8.2)
[1]
Median and upper CI was not estimable due to insufficient number of events.
2.Secondary Outcome
Title Overall Survival (OS) in Participants With HER2-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane
Hide Description Overall survival (OS) was defined as the time from the date of first dose of study drug to the date of death due to any cause.
Time Frame Up to 33 months (data cut-off)
Hide Outcome Measure Data
Hide Analysis Population Description
Overall survival (OS) was assessed in the Full Analysis Set at data cut-off date of 21 May 2021.
Arm/Group Title Trastuzumab Deruxtecan (T-DXd) Ado-trastuzumab Emtansine (T-DM1)
Hide Arm/Group Description:
Participants with HER2-positive, unresectable and/or metastatic breast cancer participants previously treated with trastuzumab and taxane who received T-DXd as a sterile intravenous (IV) solution at a dose of 5.4 mg/kg every 3 weeks (Q3W).
Participants with HER2-positive, unresectable and/or metastatic breast cancer participants previously treated with trastuzumab and taxane who received T-DM1 in accordance with the approved label.
Overall Number of Participants Analyzed 261 263
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Median and 95% CI was not estimable due insufficient number of events.
3.Secondary Outcome
Title Percentage of Participants With Objective Response Rate (ORR) Based on BICR and Investigator Assessment in Participants With HER2-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane
Hide Description The Objective Response Rate (ORR) was defined as the percentage of participants who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), assessed by BICR and investigator assessment based on RECIST version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. Confirmed ORR is reported.
Time Frame Up to 33 months (data cut-off)
Hide Outcome Measure Data
Hide Analysis Population Description
Objective response rate was assessed in the Full Analysis Set at data cut-off date of 21 May 2021.
Arm/Group Title Trastuzumab Deruxtecan (T-DXd) Ado-trastuzumab Emtansine (T-DM1)
Hide Arm/Group Description:
Participants with HER2-positive, unresectable and/or metastatic breast cancer participants previously treated with trastuzumab and taxane who received T-DXd as a sterile intravenous (IV) solution at a dose of 5.4 mg/kg every 3 weeks (Q3W).
Participants with HER2-positive, unresectable and/or metastatic breast cancer participants previously treated with trastuzumab and taxane who received T-DM1 in accordance with the approved label.
Overall Number of Participants Analyzed 261 263
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
BICR
79.7
(74.3 to 84.4)
34.2
(28.5 to 40.3)
Investigator Assessment
77.0
(71.2 to 82.0)
36.9
(31.0 to 43.0)
4.Secondary Outcome
Title Duration of Response (DoR) Based on BICR and Investigator Assessment in Participants With HER2-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane
Hide Description Duration of Response (DoR) was defined as the time from the date of the first documentation of objective response (complete response [CR] or partial response [PR]) to the date of the first objective documentation of progressive disease (PD) or death due to any cause. DoR in participants with confirmed CR/PR based on BICR and investigator assessment is reported.
Time Frame Up to 33 months (data cut-off)
Hide Outcome Measure Data
Hide Analysis Population Description
Duration of Response (DoR) was assessed in the Full Analysis Set of participants with confirmed CR/PR at data cut-off date of 21 May 2021.
Arm/Group Title Trastuzumab Deruxtecan (T-DXd) Ado-trastuzumab Emtansine (T-DM1)
Hide Arm/Group Description:
Participants with HER2-positive, unresectable and/or metastatic breast cancer participants previously treated with trastuzumab and taxane who received T-DXd as a sterile intravenous (IV) solution at a dose of 5.4 mg/kg every 3 weeks (Q3W).
Participants with HER2-positive, unresectable and/or metastatic breast cancer participants previously treated with trastuzumab and taxane who received T-DM1 in accordance with the approved label.
Overall Number of Participants Analyzed 261 263
Median (95% Confidence Interval)
Unit of Measure: months
BICR Number Analyzed 208 participants 90 participants
NA [1] 
(20.3 to NA)
NA [1] 
(12.6 to NA)
Investigator Assessment Number Analyzed 201 participants 97 participants
NA [1] 
(20.8 to NA)
NA [1] 
(14.1 to NA)
[1]
Median and upper CI was not estimable due insufficient number of events.
5.Secondary Outcome
Title Progression-Free Survival (PFS) Based on Investigator Assessment in Participants With HER2-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane
Hide Description Progression-free survival (PFS) by investigator assessment was defined as the time from the date of enrollment to the earlier of the dates of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions.
Time Frame Up to 33 months (data cut-off)
Hide Outcome Measure Data
Hide Analysis Population Description
Progression-free survival (PFS) was assessed in the Full Analysis Set at data cut-off date of 21 May 2021.
Arm/Group Title Trastuzumab Deruxtecan (T-DXd) Ado-trastuzumab Emtansine (T-DM1)
Hide Arm/Group Description:
Participants with HER2-positive, unresectable and/or metastatic breast cancer participants previously treated with trastuzumab and taxane who received T-DXd as a sterile intravenous (IV) solution at a dose of 5.4 mg/kg every 3 weeks (Q3W).
Participants with HER2-positive, unresectable and/or metastatic breast cancer participants previously treated with trastuzumab and taxane who received T-DM1 in accordance with the approved label.
Overall Number of Participants Analyzed 261 263
Median (95% Confidence Interval)
Unit of Measure: months
25.1 [1] 
(22.1 to NA)
7.2
(6.8 to 8.3)
[1]
Upper CI was not estimable due to insufficient number of events.
Time Frame Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 33 months.
Adverse Event Reporting Description A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
 
Arm/Group Title Trastuzumab Deruxtecan (T-DXd) Ado-trastuzumab Emtansine (T-DM1)
Hide Arm/Group Description Participants with HER2-positive, unresectable and/or metastatic breast cancer participants previously treated with trastuzumab and taxane who received T-DXd as a sterile intravenous (IV) solution at a dose of 5.4 mg/kg every 3 weeks (Q3W). Participants with HER2-positive, unresectable and/or metastatic breast cancer participants previously treated with trastuzumab and taxane who received T-DM1 in accordance with the approved label.
All-Cause Mortality
Trastuzumab Deruxtecan (T-DXd) Ado-trastuzumab Emtansine (T-DM1)
Affected / at Risk (%) Affected / at Risk (%)
Total   33/257 (12.84%)   53/261 (20.31%) 
Hide Serious Adverse Events
Trastuzumab Deruxtecan (T-DXd) Ado-trastuzumab Emtansine (T-DM1)
Affected / at Risk (%) Affected / at Risk (%)
Total   49/257 (19.07%)   47/261 (18.01%) 
Blood and lymphatic system disorders     
Anaemia † 1  2/257 (0.78%)  3/261 (1.15%) 
Febrile neutropenia † 1  2/257 (0.78%)  0/261 (0.00%) 
Ear and labyrinth disorders     
Otolithiasis † 1  0/257 (0.00%)  1/261 (0.38%) 
Endocrine disorders     
Hypercalcaemia of malignancy † 1  0/257 (0.00%)  1/261 (0.38%) 
Eye disorders     
Rhegmatogenous retinal detachment † 1  1/257 (0.39%)  0/261 (0.00%) 
Gastrointestinal disorders     
Vomiting † 1  5/257 (1.95%)  2/261 (0.77%) 
Nausea † 1  2/257 (0.78%)  0/261 (0.00%) 
Abdominal pain † 1  1/257 (0.39%)  1/261 (0.38%) 
Constipation † 1  1/257 (0.39%)  1/261 (0.38%) 
Campylobacter gastroenteritis † 1  1/257 (0.39%)  0/261 (0.00%) 
Colitis † 1  1/257 (0.39%)  0/261 (0.00%) 
Gastrointestinal disorder † 1  1/257 (0.39%)  0/261 (0.00%) 
Gastrointestinal polyp haemorrhage † 1  1/257 (0.39%)  0/261 (0.00%) 
Haematemesis † 1  1/257 (0.39%)  0/261 (0.00%) 
Diarrhoea † 1  0/257 (0.00%)  1/261 (0.38%) 
General disorders     
Pyrexia † 1  4/257 (1.56%)  0/261 (0.00%) 
Disease progression † 1  3/257 (1.17%)  1/261 (0.38%) 
General physical health deterioration † 1  1/257 (0.39%)  0/261 (0.00%) 
Oedema peripheral † 1  1/257 (0.39%)  0/261 (0.00%) 
Sudden death † 1  1/257 (0.39%)  0/261 (0.00%) 
Fatigue † 1  0/257 (0.00%)  1/261 (0.38%) 
Hepatobiliary disorders     
Jaundice cholestatic † 1  1/257 (0.39%)  0/261 (0.00%) 
Hepatic atrophy † 1  0/257 (0.00%)  1/261 (0.38%) 
Hepatic failure † 1  0/257 (0.00%)  1/261 (0.38%) 
Infections and infestations     
Pneumonia † 1  4/257 (1.56%)  5/261 (1.92%) 
Urinary tract infection † 1  3/257 (1.17%)  1/261 (0.38%) 
Cellulitis † 1  2/257 (0.78%)  0/261 (0.00%) 
COVID-19 † 1  1/257 (0.39%)  2/261 (0.77%) 
Breast cellulitis † 1  1/257 (0.39%)  0/261 (0.00%) 
Cytomegalovirus infection † 1  1/257 (0.39%)  0/261 (0.00%) 
Enterocolitis infectious † 1  1/257 (0.39%)  0/261 (0.00%) 
Infection † 1  1/257 (0.39%)  0/261 (0.00%) 
Influenza † 1  1/257 (0.39%)  0/261 (0.00%) 
Pneumonitis † 1  1/257 (0.39%)  0/261 (0.00%) 
Tracheobronchitis † 1  1/257 (0.39%)  0/261 (0.00%) 
Erysipelas † 1  0/257 (0.00%)  1/261 (0.38%) 
Gastroenteritis † 1  0/257 (0.00%)  1/261 (0.38%) 
Postoperative wound infection † 1  0/257 (0.00%)  1/261 (0.38%) 
Soft tissue infection † 1  0/257 (0.00%)  1/261 (0.38%) 
Injury, poisoning and procedural complications     
Femur fracture † 1  1/257 (0.39%)  0/261 (0.00%) 
Radiation necrosis † 1  1/257 (0.39%)  0/261 (0.00%) 
Spinal fracture † 1  1/257 (0.39%)  0/261 (0.00%) 
Thermal burn † 1  1/257 (0.39%)  0/261 (0.00%) 
Brain herniation † 1  0/257 (0.00%)  1/261 (0.38%) 
Femoral neck fracture † 1  0/257 (0.00%)  1/261 (0.38%) 
Lower limb fracture † 1  0/257 (0.00%)  1/261 (0.38%) 
Subdural haematoma † 1  0/257 (0.00%)  1/261 (0.38%) 
Subdural haemorrhage † 1  0/257 (0.00%)  1/261 (0.38%) 
Investigations     
Ejection fraction decreased † 1  1/257 (0.39%)  0/261 (0.00%) 
Gamma-glutamyltransferase increased † 1  1/257 (0.39%)  0/261 (0.00%) 
Platelet count decreased † 1  0/257 (0.00%)  3/261 (1.15%) 
Alanine aminotransferase increased † 1  0/257 (0.00%)  1/261 (0.38%) 
Aspartate aminotransferase increased † 1  0/257 (0.00%)  1/261 (0.38%) 
Biopsy lymph gland † 1  0/257 (0.00%)  1/261 (0.38%) 
Blood bilirubin increased † 1  0/257 (0.00%)  1/261 (0.38%) 
Metabolism and nutrition disorders     
Hypokalaemia † 1  2/257 (0.78%)  0/261 (0.00%) 
Decreased appetite † 1  1/257 (0.39%)  0/261 (0.00%) 
Dehydration † 1  1/257 (0.39%)  0/261 (0.00%) 
Hyperglycaemia † 1  1/257 (0.39%)  0/261 (0.00%) 
Lactic acidosis † 1  1/257 (0.39%)  0/261 (0.00%) 
Hypercalcaemia † 1  0/257 (0.00%)  2/261 (0.77%) 
Hyponatraemia † 1  0/257 (0.00%)  1/261 (0.38%) 
Musculoskeletal and connective tissue disorders     
Back pain † 1  1/257 (0.39%)  0/261 (0.00%) 
Bone lesion † 1  1/257 (0.39%)  0/261 (0.00%) 
Pain in extremity † 1  1/257 (0.39%)  0/261 (0.00%) 
Osteonecrosis of jaw † 1  0/257 (0.00%)  1/261 (0.38%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cancer pain † 1  0/257 (0.00%)  1/261 (0.38%) 
Colon cancer † 1  0/257 (0.00%)  1/261 (0.38%) 
Nervous system disorders     
Epilepsy † 1  1/257 (0.39%)  0/261 (0.00%) 
Vasogenic cerebral oedema † 1  1/257 (0.39%)  0/261 (0.00%) 
Altered state of consciousness † 1  0/257 (0.00%)  1/261 (0.38%) 
Optic neuritis † 1  0/257 (0.00%)  1/261 (0.38%) 
Spinal cord compression † 1  0/257 (0.00%)  1/261 (0.38%) 
Pregnancy, puerperium and perinatal conditions     
Seizure † 1  2/257 (0.78%)  0/261 (0.00%) 
Renal and urinary disorders     
Renal impairment † 1  1/257 (0.39%)  0/261 (0.00%) 
Acute kidney injury † 1  0/257 (0.00%)  1/261 (0.38%) 
Respiratory, thoracic and mediastinal disorders     
Interstitial lung disease † 1  5/257 (1.95%)  0/261 (0.00%) 
Acute respiratory failure † 1  1/257 (0.39%)  0/261 (0.00%) 
Dyspnoea † 1  1/257 (0.39%)  0/261 (0.00%) 
Epistaxis † 1  0/257 (0.00%)  1/261 (0.38%) 
Mediastinal cyst † 1  0/257 (0.00%)  1/261 (0.38%) 
Pleural effusion † 1  0/257 (0.00%)  1/261 (0.38%) 
Pneumonia aspiration † 1  0/257 (0.00%)  1/261 (0.38%) 
Pulmonary embolism † 1  0/257 (0.00%)  1/261 (0.38%) 
Vascular disorders     
Hypertension † 1  1/257 (0.39%)  0/261 (0.00%) 
Hypotension † 1  1/257 (0.39%)  0/261 (0.00%) 
Angiodysplasia † 1  0/257 (0.00%)  1/261 (0.38%) 
Arterial haemorrhage † 1  0/257 (0.00%)  1/261 (0.38%) 
Haematoma † 1  0/257 (0.00%)  1/261 (0.38%) 
1
Term from vocabulary, MedDRA (23.0)
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Trastuzumab Deruxtecan (T-DXd) Ado-trastuzumab Emtansine (T-DM1)
Affected / at Risk (%) Affected / at Risk (%)
Total   256/257 (99.61%)   249/261 (95.40%) 
Blood and lymphatic system disorders     
Anaemia † 1  83/257 (32.30%)  43/261 (16.48%) 
Neutropenia † 1  41/257 (15.95%)  7/261 (2.68%) 
Leukopenia † 1  22/257 (8.56%)  8/261 (3.07%) 
Lymphopenia † 1  15/257 (5.84%)  6/261 (2.30%) 
Thrombocytopenia † 1  13/257 (5.06%)  31/261 (11.88%) 
Gastrointestinal disorders     
Nausea † 1  195/257 (75.88%)  79/261 (30.27%) 
Vomiting † 1  126/257 (49.03%)  26/261 (9.96%) 
Constipation † 1  88/257 (34.24%)  51/261 (19.54%) 
Diarrhoea † 1  75/257 (29.18%)  18/261 (6.90%) 
Dyspepsia † 1  29/257 (11.28%)  16/261 (6.13%) 
Abdominal pain † 1  29/257 (11.28%)  5/261 (1.92%) 
Abdominal pain upper † 1  28/257 (10.89%)  12/261 (4.60%) 
Gastrooesophageal reflux disease † 1  13/257 (5.06%)  4/261 (1.53%) 
General disorders     
Fatigue † 1  74/257 (28.79%)  52/261 (19.92%) 
Asthenia † 1  32/257 (12.45%)  31/261 (11.88%) 
Malaise † 1  29/257 (11.28%)  10/261 (3.83%) 
Pyrexia † 1  27/257 (10.51%)  39/261 (14.94%) 
Oedema peripheral † 1  17/257 (6.61%)  9/261 (3.45%) 
Infections and infestations     
Stomatitis † 1  40/257 (15.56%)  10/261 (3.83%) 
Urinary tract infection † 1  19/257 (7.39%)  13/261 (4.98%) 
Pneumonia † 1  18/257 (7.00%)  9/261 (3.45%) 
Pneumonitis † 1  18/257 (7.00%)  1/261 (0.38%) 
Investigations     
Neutrophil count decreased † 1  75/257 (29.18%)  25/261 (9.58%) 
Aspartate aminotransferase increased † 1  66/257 (25.68%)  105/261 (40.23%) 
White blood cell count decreased † 1  58/257 (22.57%)  14/261 (5.36%) 
Alanine aminotransferase increased † 1  56/257 (21.79%)  77/261 (29.50%) 
Platelet count decreased † 1  54/257 (21.01%)  112/261 (42.91%) 
Blood alkaline phosphatase increased † 1  35/257 (13.62%)  30/261 (11.49%) 
Blood lactate dehydrogenase increased † 1  17/257 (6.61%)  35/261 (13.41%) 
Blood bilirubin increased † 1  17/257 (6.61%)  13/261 (4.98%) 
Lymphocyte count decreased † 1  14/257 (5.45%)  3/261 (1.15%) 
Metabolism and nutrition disorders     
Decreased appetite † 1  75/257 (29.18%)  44/261 (16.86%) 
Weight decreased † 1  43/257 (16.73%)  16/261 (6.13%) 
Hypokalaemia † 1  33/257 (12.84%)  26/261 (9.96%) 
Hypoalbuminaemia † 1  20/257 (7.78%)  12/261 (4.60%) 
Musculoskeletal and connective tissue disorders     
Back Pain † 1  24/257 (9.34%)  16/261 (6.13%) 
Myalgia † 1  23/257 (8.95%)  16/261 (6.13%) 
Arthralgia † 1  22/257 (8.56%)  23/261 (8.81%) 
Pain in extremity † 1  21/257 (8.17%)  16/261 (6.13%) 
Musculoskeletal pain † 1  17/257 (6.61%)  12/261 (4.60%) 
Nervous system disorders     
Headache † 1  54/257 (21.01%)  38/261 (14.56%) 
Dizziness † 1  32/257 (12.45%)  22/261 (8.43%) 
Peripheral sensory neuropathy † 1  19/257 (7.39%)  25/261 (9.58%) 
Dysgeusia † 1  15/257 (5.84%)  8/261 (3.07%) 
Psychiatric disorders     
Anxiety † 1  18/257 (7.00%)  6/261 (2.30%) 
Insomnia † 1  15/257 (5.84%)  24/261 (9.20%) 
Respiratory, thoracic and mediastinal disorders     
Epistaxis † 1  29/257 (11.28%)  42/261 (16.09%) 
Cough † 1  27/257 (10.51%)  26/261 (9.96%) 
Dyspnoea † 1  21/257 (8.17%)  13/261 (4.98%) 
Upper respiratory tract infection † 1  20/257 (7.78%)  15/261 (5.75%) 
Oropharyngeal pain † 1  13/257 (5.06%)  6/261 (2.30%) 
Skin and subcutaneous tissue disorders     
Alopecia † 1  95/257 (36.96%)  8/261 (3.07%) 
Pruritus † 1  21/257 (8.17%)  18/261 (6.90%) 
Rash † 1  16/257 (6.23%)  24/261 (9.20%) 
Dry skin † 1  14/257 (5.45%)  4/261 (1.53%) 
Vascular disorders     
Hypertension † 1  14/257 (5.45%)  6/261 (2.30%) 
1
Term from vocabulary, MedDRA (23.0)
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Contact for Clinical Trial Information
Organization: Daiichi Sankyo
Phone: 908-992-6400
EMail: CTRinfo@dsi.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Daiichi Sankyo
ClinicalTrials.gov Identifier: NCT03529110    
Other Study ID Numbers: DS8201-A-U302
2018-000222-61 ( EudraCT Number )
183976 ( Registry Identifier: JAPIC CTI )
DESTINY-B03 ( Other Identifier: Daiichi Sankyo and AstraZeneca )
CTR20190378 ( Registry Identifier: CDE )
First Submitted: April 13, 2018
First Posted: May 18, 2018
Results First Submitted: March 7, 2022
Results First Posted: April 29, 2022
Last Update Posted: April 18, 2024