The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of DS-8201a in Metastatic Breast Cancer Previously Treated With Trastuzumab Emtansine (T-DM1)

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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03248492
Recruitment Status : Active, not recruiting
First Posted : August 14, 2017
Results First Posted : February 17, 2020
Last Update Posted : November 15, 2023
Sponsor:
Collaborators:
AstraZeneca
Daiichi Sankyo Co., Ltd.
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
Intervention Drug: DS-8201a
Enrollment 253
Recruitment Details Participants who met all of the inclusion and none of the exclusion criteria were enrolled and randomized to treatment (Part 1) or received DS-8201a at the recommended dose (Part 2).
Pre-assignment Details In Part 1, participants were randomized 1:1:1 to either 5.4 mg/kg, 6.4 mg/kg, or 7.4 mg/kg dose of DS-8201a. Two doses randomized 1:1 (6.4 mg/kg and 7.4 mg/kg) were further evaluated. In Part 2, all T-DM1 resistant refractory participants (cohort 2a) or T-DM1 intolerant (cohort 2b) received DS-8201a at the recommended dose.
Arm/Group Title Part 1: DS-8201a Low Dose Part 1: DS-8201a Medium Dose Part 1: DS-8201a High Dose Part 2a: DS-8201a Low Dose Part 2b (Exploratory): DS-8201a Low Dose
Hide Arm/Group Description T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a low dose (5.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases. T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a medium dose (6.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases. T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a high dose (7.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phase. All T-DM1 resistant/refractory (R/R) participants who were treated at the recommended (5.4 mg/kg) dose in Part 2a in the continuation phase. All participants who were previously treated with T-DM1 and were randomized to receive DS8201a low dose (5.4 mg/kg) in Part 2b in the continuation phase.
Period Title: Overall Study
Started 50 48 21 130 4
Completed [1] 0 0 0 0 0
Not Completed 50 48 21 130 4
Reason Not Completed
Ongoing             23             26             3             85             2
Progressive disease per RECIST v1.1             16             12             9             22             0
Adverse Event             6             6             8             8             1
Withdrawal by Subject             3             3             0             3             1
Physician Decision             1             0             1             2             0
Death             1             0             0             6             0
Other             0             1             0             4             0
[1]
Data from the Ongoing and Discontinued participants are presented as of data cutoff on 21 March 2019
Arm/Group Title Part 1: DS-8201a Low Dose Part 1: DS-8201a Medium Dose Part 1: DS-8201a High Dose Part 2a: DS-8201a Low Dose Part 2b (Exploratory): DS-8201a Low Dose Total
Hide Arm/Group Description T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a low dose (5.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases. T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a medium dose (6.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases. T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a high dose (7.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases. All T-DM1 resistant/refractory (R/R) participants who were treated at the recommended (5.4 mg/kg) dose in Part 2a in the continuation phase. All participants who were previously treated with T-DM1 and were randomized to receive DS8201a low dose (5.4 mg/kg) in Part 2b in the continuation phase. Total of all reporting groups
Overall Number of Baseline Participants 50 48 21 130 4 253
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 48 participants 21 participants 130 participants 4 participants 253 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
35
  70.0%
33
  68.8%
16
  76.2%
101
  77.7%
4
 100.0%
189
  74.7%
>=65 years
15
  30.0%
15
  31.3%
5
  23.8%
29
  22.3%
0
   0.0%
64
  25.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 48 participants 21 participants 130 participants 4 participants 253 participants
57.9  (11.3) 55.8  (13.0) 54.4  (10.5) 55.4  (11.9) 49.8  (9.2) 55.8  (11.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 48 participants 21 participants 130 participants 4 participants 253 participants
Female
50
 100.0%
48
 100.0%
21
 100.0%
130
 100.0%
4
 100.0%
253
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 48 participants 21 participants 130 participants 4 participants 253 participants
American Indian or Alaska Native
0
   0.0%
1
   2.1%
0
   0.0%
0
   0.0%
1
  25.0%
2
   0.8%
Asian
22
  44.0%
22
  45.8%
12
  57.1%
47
  36.2%
1
  25.0%
104
  41.1%
Native Hawaiian or Other Pacific Islander
1
   2.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.4%
Black or African American
2
   4.0%
0
   0.0%
1
   4.8%
1
   0.8%
1
  25.0%
5
   2.0%
White
24
  48.0%
23
  47.9%
8
  38.1%
76
  58.5%
1
  25.0%
132
  52.2%
More than one race
1
   2.0%
1
   2.1%
0
   0.0%
2
   1.5%
0
   0.0%
4
   1.6%
Unknown or Not Reported
0
   0.0%
1
   2.1%
0
   0.0%
4
   3.1%
0
   0.0%
5
   2.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 50 participants 48 participants 21 participants 130 participants 4 participants 253 participants
South Korea 7 7 0 25 1 40
Belgium 0 2 0 7 0 9
United States 15 14 10 36 2 77
Japan 16 15 11 14 0 56
Italy 0 1 0 8 1 10
United Kingdom 0 0 0 12 0 12
France 2 1 0 17 0 20
Spain 10 8 0 11 0 29
1.Primary Outcome
Title Objective Response Rate as Confirmed by Independent Central Review Following Intravenous Administration of 5.4 mg/kg DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)
Hide Description The number of participants with objective response was assessed every six weeks from Cycle 1 Day 1 through discontinuation of treatment, by independent central imaging facility review based on RECIST version 1.1.
Time Frame at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)
Hide Outcome Measure Data
Hide Analysis Population Description
Objective response rate (ORR) was assessed in the Enrolled Analysis Set.at data cut-off date of 21 March 2019
Arm/Group Title Part 1 and Part 2a: DS-8201a Low Dose Part 1 + Part 2a + Part 2b: DS-8201a Low Dose
Hide Arm/Group Description:
All T-DM1 resistant/refractory (R/R) participants who were treated in Part 1 or Part 2a at the recommended (5.4 mg/kg) dose.
All participants who were previously treated with T-DM1 and were randomized to receive DS8201a low dose (5.4 mg/kg) in Part 1 or Part 2a or Part 2b.
Overall Number of Participants Analyzed 180 184
Measure Type: Count of Participants
Unit of Measure: Participants
109
  60.6%
111
  60.3%
2.Secondary Outcome
Title Objective Response Rate as Confirmed By the Investigator Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)
Hide Description The number of participants with objective response is assessed every six weeks from Cycle 1 Day 1 through discontinuation of treatment. Investigator-assessed objective response rate (ORR) was defined as the proportion of participants who achieved a best overall response of complete response or partial response based on local radiologists/investigators' tumor assessments.
Time Frame at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)
Hide Outcome Measure Data
Hide Analysis Population Description
Objective response rate (ORR) was assessed in the Enrolled Analysis Set at data cut-off date of 21 March 2019.
Arm/Group Title Part 1 and Part 2a: DS-8201a Low Dose Part 1 + Part 2a + Part 2b: DS-8201a Low Dose Part 1: DS-8201a Medium Dose Part 1: DS-8201a High Dose
Hide Arm/Group Description:
All T-DM1 resistant/refractory (R/R) participants who were treated in Part 1 or Part 2a at the recommended (5.4 mg/kg) dose.
All participants who were previously treated with T-DM1 and were randomized to receive DS8201a low dose (5.4 mg/kg) in Part 1 or Part 2a or Part 2b.
T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a medium dose (6.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a high dose (7.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
Overall Number of Participants Analyzed 180 184 48 21
Measure Type: Count of Participants
Unit of Measure: Participants
116
  64.4%
118
  64.1%
37
  77.1%
18
  85.7%
3.Secondary Outcome
Title Best Overall Tumor Response as Confirmed By the Investigator Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)
Hide Description Best overall tumor response was defined as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) by the investigator based on RECIST v1.1. Participants who were non-evaluable (NE) are also reported.
Time Frame at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)
Hide Outcome Measure Data
Hide Analysis Population Description
Best overall tumor response was assessed in the Enrolled Analysis Set at data cut-off date of 21 March 2019.
Arm/Group Title Part 1: DS-8201a Medium Dose Part 1: DS-8201a High Dose Part 1 + Part 2a: DS-8201a Low Dose Part 1 + Part 2a + Part 2b: DS-8201a Low Dose
Hide Arm/Group Description:
T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a medium dose (6.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a high dose (7.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
All T-DM1 resistant/refractory (R/R) participants who were treated at the recommended (5.4 mg/kg) dose in Part 1 or Part 2a.
All participants who were previously treated with T-DM1 and were randomized to receive DS8201a low dose (5.4 mg/kg) in Part 1 or Part 2a or Part 2b.
Overall Number of Participants Analyzed 48 21 180 184
Measure Type: Count of Participants
Unit of Measure: Participants
Complete response
3
   6.3%
0
   0.0%
4
   2.2%
6
   3.3%
Partial response
34
  70.8%
18
  85.7%
112
  62.2%
112
  60.9%
Stable disease
10
  20.8%
3
  14.3%
59
  32.8%
61
  33.2%
Progressive disease
0
   0.0%
0
   0.0%
4
   2.2%
4
   2.2%
Non-evaluable
1
   2.1%
0
   0.0%
1
   0.6%
1
   0.5%
4.Secondary Outcome
Title Disease Control Rate and Clinical Benefit Rate as Confirmed by Independent Central Review Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)
Hide Description Number of participants with controlled disease and who received clinical benefit from treatment as assessed by independent central review. DCR was defined as the proportion of participants who achieved a best overall response of complete response, partial response, or stable disease. CBR was defined as the proportion of participants who achieved a best overall response of complete response or partial response or more than 6 months of stable disease.
Time Frame at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)
Hide Outcome Measure Data
Hide Analysis Population Description
Disease control rate (DCR) and clinical benefit rate (CBR) were assessed in the Enrolled Analysis Set at data cut-off date of 21 March 2019.
Arm/Group Title Part 1: DS-8201a Medium Dose Part 1: DS-8201a High Dose Part 1 + Part 2a: DS-8201a Low Dose Part 1 + Part 2a + Part 2b: DS-8201a Low Dose
Hide Arm/Group Description:
T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a medium dose (6.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a high dose (7.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
All T-DM1 resistant/refractory (R/R) participants who were treated at the recommended (5.4 mg/kg) dose in Part 1 or Part 2a.
All participants who were previously treated with T-DM1 and were randomized to receive DS8201a low dose (5.4 mg/kg) in Part 1 or Part 2a or Part 2b.
Overall Number of Participants Analyzed 48 21 180 184
Measure Type: Count of Participants
Unit of Measure: Participants
Disease control rate
47
  97.9%
21
 100.0%
175
  97.2%
179
  97.3%
Clinical benefit rate
41
  85.4%
20
  95.2%
127
  70.6%
130
  70.7%
5.Secondary Outcome
Title Duration of Response (Complete Response or Partial Response) as Confirmed by Independent Central Review Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)
Hide Description The estimated duration of confirmed response (complete response [CR] or partial response [PR]) was assessed by independent central review. Duration of response was defined as the time interval between the date of first documentation of objective response (CR or PR) and the date of the first objective documentation of disease progression or death due to any cause.
Time Frame at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with CR or PR were analyzed. Estimated duration of response was assessed in the Enrolled Analysis Set at data cut-off date of 21 March 2019.
Arm/Group Title Part 1: DS-8201a Medium Dose Part 1: DS-8201a High Dose Part 1 + Part 2a: DS-8201a Low Dose Part 1 + Part 2a + Part 2b: DS-8201a Low Dose
Hide Arm/Group Description:
T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a medium dose (6.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a high dose (7.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
All T-DM1 resistant/refractory (R/R) participants who were treated at the recommended (5.4 mg/kg) dose in Part 1 or Part 2a.
All participants who were previously treated with T-DM1 and were randomized to receive DS8201a low dose (5.4 mg/kg) in Part 1 or Part 2a or Part 2b.
Overall Number of Participants Analyzed 33 17 109 111
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(8.3 to NA)
6.0
(4.8 to 8.3)
NA [2] 
(NA to NA)
NA [2] 
(NA to NA)
[1]
There were not enough events to estimate a standard error for the median survival time.
[2]
Lack of a median value is due to less than 50% of the participants experiencing the event.
6.Secondary Outcome
Title Progression-Free Survival Estimate As Confirmed by Independent Central Review Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)
Hide Description The point estimate of progression-free survival (PFS) is reported. PFS was defined as the time interval between the date of randomization/registration and the first documentation of disease progression or death due to any cause.
Time Frame at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)
Hide Outcome Measure Data
Hide Analysis Population Description
Progression-free survival was assessed in the Enrolled Analysis Set at data cut-off date of 21 March 2019.
Arm/Group Title Part 1: DS-8201a Medium Dose Part 1: DS-8201a High Dose Part 1 + Part 2a: DS-8201a Low Dose Part 1 + Part 2a + Part 2b: DS-8201a Low Dose
Hide Arm/Group Description:
T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a medium dose (6.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a high dose (7.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
All T-DM1 resistant/refractory (R/R) participants who were treated at the recommended (5.4 mg/kg) dose in Part 1 or Part 2a.
All participants who were previously treated with T-DM1 and were randomized to receive DS8201a low dose (5.4 mg/kg) in Part 1 or Part 2a or Part 2b.
Overall Number of Participants Analyzed 48 21 180 184
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
9.5
(7.4 to 13.2)
NA [2] 
(10.6 to NA)
NA [2] 
(10.6 to NA)
[1]
Lack of a median value is due to less than 50% of the participants experiencing the event.
[2]
There were not enough events to estimate a standard error for the median survival time.
7.Secondary Outcome
Title Percent Change From Baseline in Sum of Diameters Over Time as Determined by Independent Central Review Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)
Hide Description Best percent change in sum of diameters of measurable tumors was based on RECIST 1.1. The best percent change was defined as the percent change in the smallest sum of diameters from all post-baseline tumor assessments, taking as reference the baseline sum of diameters.
Time Frame Baseline up to Week 6, 12, 18, 24, 30, 36 post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Best percent change from baseline in sum of diameters was assessed in the Enrolled Analysis Set at data cut-off date of 21 March 2019.
Arm/Group Title Part 1: DS-8201a Medium Dose Part 1: DS-8201a High Dose Part 1 + Part 2a: DS-8201a Low Dose Part 1 + Part 2a + Part 2b: DS-8201a Low Dose
Hide Arm/Group Description:
T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a medium dose (6.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a high dose (7.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
All T-DM1 resistant/refractory (R/R) participants who were treated at the recommended (5.4 mg/kg) dose in Part 1 or Part 2a.
All participants who were previously treated with T-DM1 and were randomized to receive DS8201a low dose (5.4 mg/kg) in Part 1 or Part 2a or Part 2b.
Overall Number of Participants Analyzed 48 21 180 184
Mean (Standard Deviation)
Unit of Measure: Percent change from baseline
Baseline to Week 6 Number Analyzed 43 participants 21 participants 164 participants 167 participants
-26.2  (18.3) -32.9  (25.4) -26.9  (21.6) -26.9  (22.5)
Baseline to Week 12 Number Analyzed 40 participants 21 participants 152 participants 154 participants
-39.6  (22.7) -43.6  (28.1) -39.9  (24.5) -40.1  (24.9)
Baseline to Week 18 Number Analyzed 37 participants 19 participants 136 participants 138 participants
-50.1  (22.1) -58.5  (29.4) -44.4  (27.8) -44.9  (28.0)
Baseline to Week 24 Number Analyzed 31 participants 17 participants 124 participants 125 participants
-56.3  (22.1) -61.9  (32.0) -49.2  (30.6) -49.3  (30.5)
Baseline to Week 30 Number Analyzed 30 participants 15 participants 80 participants 81 participants
-59.1  (26.1) -63.9  (32.2) -51.2  (29.2) -51.5  (29.2)
Baseline to Week 36 Number Analyzed 24 participants 9 participants 46 participants 46 participants
-61.0  (26.7) -54.6  (32.2) -55.5  (29.9) -55.5  (29.9)
Best percent change from baseline Number Analyzed 43 participants 21 participants 166 participants 169 participants
-59.5  (28.2) -65.3  (27.7) -50.5  (28.3) -50.6  (28.8)
8.Secondary Outcome
Title Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Safety Analysis Set)
Hide Description TEAEs were assessed by severity and seriousness according to unique criteria. Severity described the intensity of an event and was graded using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03, where Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL); Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL; Grade 4: Life-threatening consequences; urgent intervention indicated; and Grade 5: Death related to AE. Serious TEAEs were defined as any untoward medical occurrence that at any dose results in death, is life threatening, requires inpatient hospitalization, or causes prolongation of existing hospitalization.
Time Frame Day 0 to Day 47 post last dose
Hide Outcome Measure Data
Hide Analysis Population Description
Adverse event data were assessed in the Safety Analysis Set t data cut-off date of 21 March 2019.
Arm/Group Title Part 1: DS-8201a Low Dose Part 1: DS-8201a Medium Dose Part 1: DS-8201a High Dose Part 2a: DS-8201a Low Dose Part 2b (Exploratory): DS-8201a Low Dose
Hide Arm/Group Description:
T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a low dose (5.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a medium dose (6.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a high dose (7.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
All T-DM1 resistant/refractory (R/R) participants who were treated at the recommended (5.4 mg/kg) dose in the continuation phase.
All participants who were T-DM1 intolerant and treated at the recommend dose (5.4 mg/kg) in the continuation phase.
Overall Number of Participants Analyzed 50 48 21 130 4
Measure Type: Count of Participants
Unit of Measure: Participants
Any TEAE
50
 100.0%
48
 100.0%
21
 100.0%
129
  99.2%
4
 100.0%
Drug-related TEAEs
50
 100.0%
47
  97.9%
21
 100.0%
128
  98.5%
4
 100.0%
Drug-related TEAEs of CTCAE ≥Grade 3
26
  52.0%
32
  66.7%
16
  76.2%
48
  36.9%
3
  75.0%
Any serious TEAE
11
  22.0%
6
  12.5%
8
  38.1%
25
  19.2%
0
   0.0%
Drug-related serious TEAEs
6
  12.0%
4
   8.3%
5
  23.8%
10
   7.7%
0
   0.0%
TEAEs associated with drug discontinuation
6
  12.0%
6
  12.5%
8
  38.1%
8
   6.2%
1
  25.0%
Related TEAEs associated with drug discontinuation
6
  12.0%
6
  12.5%
8
  38.1%
7
   5.4%
1
  25.0%
TEAEs associated with dose reduction
13
  26.0%
19
  39.6%
11
  52.4%
21
  16.2%
3
  75.0%
Drug-related TEAEs associated with dose reduction
11
  22.0%
18
  37.5%
11
  52.4%
20
  15.4%
3
  75.0%
TEAEs associated with dose interruption
19
  38.0%
16
  33.3%
12
  57.1%
36
  27.7%
2
  50.0%
Related TEAEs associated with drug interruption
17
  34.0%
13
  27.1%
11
  52.4%
29
  22.3%
2
  50.0%
TEAEs associated with death
1
   2.0%
1
   2.1%
2
   9.5%
8
   6.2%
0
   0.0%
Drug-related TEAEs associated with death
0
   0.0%
0
   0.0%
1
   4.8%
2
   1.5%
0
   0.0%
Time Frame Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
Adverse Event Reporting Description A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
 
Arm/Group Title Part 1: DS-8201a Low Dose Part 1: DS-8201a Medium Dose Part 1: DS-8201a High Dose Part 2a: DS-8201a Low Dose Part 2b (Exploratory): DS-8201a Low Dose
Hide Arm/Group Description T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a low dose (5.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases. T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a medium dose (6.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases. T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a high dose (7.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases. All T-DM1 resistant/refractory (R/R) participants who were treated at the recommended (5.4 mg/kg) dose in Part 2a in the continuation phase. All participants who were T-DM1 intolerant and treated at the recommend dose (5.4 mg/kg) in Part 2b in the continuation phase.
All-Cause Mortality
Part 1: DS-8201a Low Dose Part 1: DS-8201a Medium Dose Part 1: DS-8201a High Dose Part 2a: DS-8201a Low Dose Part 2b (Exploratory): DS-8201a Low Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/50 (12.00%)   7/48 (14.58%)   8/21 (38.10%)   13/130 (10.00%)   0/4 (0.00%) 
Hide Serious Adverse Events
Part 1: DS-8201a Low Dose Part 1: DS-8201a Medium Dose Part 1: DS-8201a High Dose Part 2a: DS-8201a Low Dose Part 2b (Exploratory): DS-8201a Low Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   11/50 (22.00%)   6/48 (12.50%)   8/21 (38.10%)   25/130 (19.23%)   0/4 (0.00%) 
Blood and lymphatic system disorders           
Anemia † 1  1/50 (2.00%)  0/48 (0.00%)  0/21 (0.00%)  0/130 (0.00%)  0/4 (0.00%) 
Thrombocytopenia † 1  0/50 (0.00%)  1/48 (2.08%)  0/21 (0.00%)  0/130 (0.00%)  0/4 (0.00%) 
Hematuria † 1  0/50 (0.00%)  0/48 (0.00%)  0/21 (0.00%)  1/130 (0.77%)  0/4 (0.00%) 
Shock hemorrhagic † 1  1/50 (2.00%)  0/48 (0.00%)  0/21 (0.00%)  0/130 (0.00%)  0/4 (0.00%) 
Febrile neutropenia † 1  0/50 (0.00%)  0/48 (0.00%)  1/21 (4.76%)  0/130 (0.00%)  0/4 (0.00%) 
Cardiac disorders           
Cardiac failure congestive † 1  0/50 (0.00%)  0/48 (0.00%)  0/21 (0.00%)  1/130 (0.77%)  0/4 (0.00%) 
Gastrointestinal disorders           
Vomiting † 1  2/50 (4.00%)  1/48 (2.08%)  0/21 (0.00%)  2/130 (1.54%)  0/4 (0.00%) 
Intestinal obstruction † 1  0/50 (0.00%)  0/48 (0.00%)  0/21 (0.00%)  3/130 (2.31%)  0/4 (0.00%) 
Nausea † 1  0/50 (0.00%)  2/48 (4.17%)  0/21 (0.00%)  3/130 (2.31%)  0/4 (0.00%) 
Abdominal pain † 1  0/50 (0.00%)  0/48 (0.00%)  0/21 (0.00%)  2/130 (1.54%)  0/4 (0.00%) 
Abdominal abscess † 1  0/50 (0.00%)  0/48 (0.00%)  0/21 (0.00%)  1/130 (0.77%)  0/4 (0.00%) 
Ascites † 1  0/50 (0.00%)  0/48 (0.00%)  0/21 (0.00%)  1/130 (0.77%)  0/4 (0.00%) 
Dysphagia † 1  0/50 (0.00%)  0/48 (0.00%)  0/21 (0.00%)  1/130 (0.77%)  0/4 (0.00%) 
Upper gastrointestinal hemorrhage † 1  1/50 (2.00%)  0/48 (0.00%)  0/21 (0.00%)  0/130 (0.00%)  0/4 (0.00%) 
General disorders           
Disease progression † 1  0/50 (0.00%)  0/48 (0.00%)  1/21 (4.76%)  1/130 (0.77%)  0/4 (0.00%) 
Pain † 1  0/50 (0.00%)  0/48 (0.00%)  1/21 (4.76%)  0/130 (0.00%)  0/4 (0.00%) 
General physical health deterioration † 1  0/50 (0.00%)  0/48 (0.00%)  0/21 (0.00%)  1/130 (0.77%)  0/4 (0.00%) 
Asthenia † 1  0/50 (0.00%)  1/48 (2.08%)  0/21 (0.00%)  0/130 (0.00%)  0/4 (0.00%) 
Hepatobiliary disorders           
Pyelonephritis † 1  1/50 (2.00%)  0/48 (0.00%)  0/21 (0.00%)  1/130 (0.77%)  0/4 (0.00%) 
Acute hepatic failure † 1  0/50 (0.00%)  0/48 (0.00%)  0/21 (0.00%)  1/130 (0.77%)  0/4 (0.00%) 
Acute kidney injury † 1  0/50 (0.00%)  0/48 (0.00%)  0/21 (0.00%)  1/130 (0.77%)  0/4 (0.00%) 
Cholecystitis † 1  0/50 (0.00%)  0/48 (0.00%)  0/21 (0.00%)  1/130 (0.77%)  0/4 (0.00%) 
Immune system disorders           
Hypersensitivity † 1  1/50 (2.00%)  0/48 (0.00%)  0/21 (0.00%)  0/130 (0.00%)  0/4 (0.00%) 
Infections and infestations           
Cellulitis † 1  3/50 (6.00%)  0/48 (0.00%)  0/21 (0.00%)  0/130 (0.00%)  0/4 (0.00%) 
Pneumonia † 1  0/50 (0.00%)  1/48 (2.08%)  0/21 (0.00%)  3/130 (2.31%)  0/4 (0.00%) 
Urinary tract infection † 1  0/50 (0.00%)  0/48 (0.00%)  0/21 (0.00%)  2/130 (1.54%)  0/4 (0.00%) 
Diverticulitis † 1  1/50 (2.00%)  0/48 (0.00%)  0/21 (0.00%)  0/130 (0.00%)  0/4 (0.00%) 
Influenza † 1  0/50 (0.00%)  0/48 (0.00%)  1/21 (4.76%)  0/130 (0.00%)  0/4 (0.00%) 
Lung infection † 1  0/50 (0.00%)  0/48 (0.00%)  1/21 (4.76%)  0/130 (0.00%)  0/4 (0.00%) 
Parotitis † 1  0/50 (0.00%)  1/48 (2.08%)  0/21 (0.00%)  0/130 (0.00%)  0/4 (0.00%) 
Soft tissue infection † 1  0/50 (0.00%)  0/48 (0.00%)  1/21 (4.76%)  0/130 (0.00%)  0/4 (0.00%) 
Lower respiratory tract infection † 1  0/50 (0.00%)  0/48 (0.00%)  0/21 (0.00%)  1/130 (0.77%)  0/4 (0.00%) 
Lymphangitis † 1  0/50 (0.00%)  0/48 (0.00%)  0/21 (0.00%)  1/130 (0.77%)  0/4 (0.00%) 
Osteomyelitis † 1  1/50 (2.00%)  0/48 (0.00%)  0/21 (0.00%)  0/130 (0.00%)  0/4 (0.00%) 
Pneumonitis † 1  0/50 (0.00%)  0/48 (0.00%)  1/21 (4.76%)  1/130 (0.77%)  0/4 (0.00%) 
Sepsis † 1  0/50 (0.00%)  0/48 (0.00%)  0/21 (0.00%)  1/130 (0.77%)  0/4 (0.00%) 
Injury, poisoning and procedural complications           
Ilium fracture † 1  0/50 (0.00%)  1/48 (2.08%)  0/21 (0.00%)  0/130 (0.00%)  0/4 (0.00%) 
Femoral neck fracture † 1  0/50 (0.00%)  0/48 (0.00%)  1/21 (4.76%)  0/130 (0.00%)  0/4 (0.00%) 
Investigations           
Neutrophil count decreased † 1  0/50 (0.00%)  1/48 (2.08%)  0/21 (0.00%)  0/130 (0.00%)  0/4 (0.00%) 
Alanine aminotransferase increased † 1  0/50 (0.00%)  0/48 (0.00%)  2/21 (9.52%)  0/130 (0.00%)  0/4 (0.00%) 
Aspartate aminotransferase increased † 1  0/50 (0.00%)  0/48 (0.00%)  2/21 (9.52%)  0/130 (0.00%)  0/4 (0.00%) 
Metabolism and nutrition disorders           
Hypokalemia † 1  0/50 (0.00%)  0/48 (0.00%)  0/21 (0.00%)  2/130 (1.54%)  0/4 (0.00%) 
Hyperkalemia † 1  0/50 (0.00%)  0/48 (0.00%)  0/21 (0.00%)  1/130 (0.77%)  0/4 (0.00%) 
Hyponatremia † 1  0/50 (0.00%)  0/48 (0.00%)  1/21 (4.76%)  0/130 (0.00%)  0/4 (0.00%) 
Musculoskeletal and connective tissue disorders           
Back pain † 1  0/50 (0.00%)  0/48 (0.00%)  0/21 (0.00%)  1/130 (0.77%)  0/4 (0.00%) 
Muscular weakness † 1  0/50 (0.00%)  1/48 (2.08%)  0/21 (0.00%)  0/130 (0.00%)  0/4 (0.00%) 
Flank pain † 1  0/50 (0.00%)  0/48 (0.00%)  0/21 (0.00%)  1/130 (0.77%)  0/4 (0.00%) 
Nervous system disorders           
Epilepsy † 1  1/50 (2.00%)  0/48 (0.00%)  0/21 (0.00%)  0/130 (0.00%)  0/4 (0.00%) 
Presyncope † 1  1/50 (2.00%)  0/48 (0.00%)  0/21 (0.00%)  0/130 (0.00%)  0/4 (0.00%) 
Reproductive system and breast disorders           
Genital hemorrhage † 1  0/50 (0.00%)  0/48 (0.00%)  0/21 (0.00%)  1/130 (0.77%)  0/4 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Pleural effusion † 1  2/50 (4.00%)  0/48 (0.00%)  1/21 (4.76%)  0/130 (0.00%)  0/4 (0.00%) 
Acute respiratory failure † 1  0/50 (0.00%)  0/48 (0.00%)  0/21 (0.00%)  1/130 (0.77%)  0/4 (0.00%) 
Dyspnea † 1  0/50 (0.00%)  0/48 (0.00%)  1/21 (4.76%)  1/130 (0.77%)  0/4 (0.00%) 
Interstitial lung disease † 1  0/50 (0.00%)  1/48 (2.08%)  1/21 (4.76%)  0/130 (0.00%)  0/4 (0.00%) 
Pulmonary embolism † 1  0/50 (0.00%)  1/48 (2.08%)  1/21 (4.76%)  0/130 (0.00%)  0/4 (0.00%) 
Hypoxia † 1  0/50 (0.00%)  0/48 (0.00%)  0/21 (0.00%)  1/130 (0.77%)  0/4 (0.00%) 
Respiratory failure † 1  0/50 (0.00%)  0/48 (0.00%)  0/21 (0.00%)  1/130 (0.77%)  0/4 (0.00%) 
Vascular disorders           
Hypotension † 1  0/50 (0.00%)  1/48 (2.08%)  0/21 (0.00%)  0/130 (0.00%)  0/4 (0.00%) 
1
Term from vocabulary, MedDRA v20.1
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Part 1: DS-8201a Low Dose Part 1: DS-8201a Medium Dose Part 1: DS-8201a High Dose Part 2a: DS-8201a Low Dose Part 2b (Exploratory): DS-8201a Low Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   50/50 (100.00%)   48/48 (100.00%)   21/21 (100.00%)   129/130 (99.23%)   4/4 (100.00%) 
Blood and lymphatic system disorders           
Anemia † 1  16/50 (32.00%)  20/48 (41.67%)  10/21 (47.62%)  31/130 (23.85%)  0/4 (0.00%) 
Neutropenia † 1  7/50 (14.00%)  6/48 (12.50%)  5/21 (23.81%)  13/130 (10.00%)  1/4 (25.00%) 
Lymphopenia † 1  2/50 (4.00%)  0/48 (0.00%)  0/21 (0.00%)  8/130 (6.15%)  0/4 (0.00%) 
Thrombocytopenia † 1  2/50 (4.00%)  4/48 (8.33%)  2/21 (9.52%)  5/130 (3.85%)  1/4 (25.00%) 
Leukopenia † 1  0/50 (0.00%)  0/48 (0.00%)  1/21 (4.76%)  3/130 (2.31%)  1/4 (25.00%) 
Cardiac disorders           
Mitral valve incompetence † 1  0/50 (0.00%)  0/48 (0.00%)  0/21 (0.00%)  0/130 (0.00%)  1/4 (25.00%) 
Ear and labyrinth disorders           
Tinnitus † 1  0/50 (0.00%)  0/48 (0.00%)  0/21 (0.00%)  3/130 (2.31%)  1/4 (25.00%) 
Eye disorders           
Dry eye † 1  4/50 (8.00%)  5/48 (10.42%)  3/21 (14.29%)  16/130 (12.31%)  0/4 (0.00%) 
Keratitis † 1  2/50 (4.00%)  3/48 (6.25%)  1/21 (4.76%)  1/130 (0.77%)  0/4 (0.00%) 
Lacrimation increased † 1  0/50 (0.00%)  3/48 (6.25%)  0/21 (0.00%)  3/130 (2.31%)  0/4 (0.00%) 
Visual impairment † 1  1/50 (2.00%)  2/48 (4.17%)  0/21 (0.00%)  1/130 (0.77%)  1/4 (25.00%) 
Gastrointestinal disorders           
Nausea † 1  38/50 (76.00%)  40/48 (83.33%)  13/21 (61.90%)  101/130 (77.69%)  2/4 (50.00%) 
Vomiting † 1  23/50 (46.00%)  19/48 (39.58%)  7/21 (33.33%)  58/130 (44.62%)  2/4 (50.00%) 
Constipation † 1  16/50 (32.00%)  17/48 (35.42%)  10/21 (47.62%)  46/130 (35.38%)  1/4 (25.00%) 
Diarrhea † 1  15/50 (30.00%)  13/48 (27.08%)  4/21 (19.05%)  33/130 (25.38%)  1/4 (25.00%) 
Stomatitis † 1  10/50 (20.00%)  13/48 (27.08%)  4/21 (19.05%)  11/130 (8.46%)  2/4 (50.00%) 
Dyspepsia † 1  3/50 (6.00%)  5/48 (10.42%)  0/21 (0.00%)  19/130 (14.62%)  0/4 (0.00%) 
Abdominal pain † 1  5/50 (10.00%)  2/48 (4.17%)  3/21 (14.29%)  16/130 (12.31%)  0/4 (0.00%) 
Gastroesophageal reflux disease † 1  8/50 (16.00%)  2/48 (4.17%)  2/21 (9.52%)  7/130 (5.38%)  0/4 (0.00%) 
Abdominal pain upper † 1  3/50 (6.00%)  0/48 (0.00%)  0/21 (0.00%)  8/130 (6.15%)  0/4 (0.00%) 
Hemorrhoids † 1  3/50 (6.00%)  2/48 (4.17%)  1/21 (4.76%)  5/130 (3.85%)  1/4 (25.00%) 
Abdominal distension † 1  3/50 (6.00%)  1/48 (2.08%)  0/21 (0.00%)  1/130 (0.77%)  0/4 (0.00%) 
Dysphagia † 1  0/50 (0.00%)  0/48 (0.00%)  2/21 (9.52%)  4/130 (3.08%)  0/4 (0.00%) 
Ascites † 1  0/50 (0.00%)  3/48 (6.25%)  1/21 (4.76%)  3/130 (2.31%)  0/4 (0.00%) 
Toothache † 1  3/50 (6.00%)  1/48 (2.08%)  0/21 (0.00%)  0/130 (0.00%)  0/4 (0.00%) 
Abdominal discomfort † 1  1/50 (2.00%)  0/48 (0.00%)  2/21 (9.52%)  0/130 (0.00%)  0/4 (0.00%) 
General disorders           
Fatigue † 1  21/50 (42.00%)  24/48 (50.00%)  11/21 (52.38%)  65/130 (50.00%)  2/4 (50.00%) 
Asthenia † 1  9/50 (18.00%)  7/48 (14.58%)  0/21 (0.00%)  15/130 (11.54%)  1/4 (25.00%) 
Pyrexia † 1  2/50 (4.00%)  10/48 (20.83%)  4/21 (19.05%)  11/130 (8.46%)  0/4 (0.00%) 
Mucosal inflammation † 1  1/50 (2.00%)  2/48 (4.17%)  0/21 (0.00%)  10/130 (7.69%)  0/4 (0.00%) 
Odema peripheral † 1  2/50 (4.00%)  6/48 (12.50%)  0/21 (0.00%)  8/130 (6.15%)  0/4 (0.00%) 
Malaise † 1  3/50 (6.00%)  3/48 (6.25%)  5/21 (23.81%)  2/130 (1.54%)  0/4 (0.00%) 
Infections and infestations           
Urinary tract infection † 1  4/50 (8.00%)  3/48 (6.25%)  2/21 (9.52%)  12/130 (9.23%)  1/4 (25.00%) 
Upper respiratory tract infection † 1  6/50 (12.00%)  1/48 (2.08%)  1/21 (4.76%)  10/130 (7.69%)  0/4 (0.00%) 
Nasopharyngitis † 1  5/50 (10.00%)  3/48 (6.25%)  3/21 (14.29%)  8/130 (6.15%)  0/4 (0.00%) 
Cystitis † 1  2/50 (4.00%)  2/48 (4.17%)  1/21 (4.76%)  2/130 (1.54%)  1/4 (25.00%) 
Cellulitis † 1  3/50 (6.00%)  1/48 (2.08%)  0/21 (0.00%)  1/130 (0.77%)  0/4 (0.00%) 
Herpes zoster † 1  3/50 (6.00%)  0/48 (0.00%)  0/21 (0.00%)  1/130 (0.77%)  0/4 (0.00%) 
Influenza † 1  0/50 (0.00%)  2/48 (4.17%)  2/21 (9.52%)  3/130 (2.31%)  0/4 (0.00%) 
Conjunctivitis † 1  0/50 (0.00%)  3/48 (6.25%)  1/21 (4.76%)  2/130 (1.54%)  0/4 (0.00%) 
Pharyngitis † 1  1/50 (2.00%)  3/48 (6.25%)  0/21 (0.00%)  0/130 (0.00%)  0/4 (0.00%) 
Injury, poisoning and procedural complications           
Infusion-related reaction † 1  3/50 (6.00%)  0/48 (0.00%)  0/21 (0.00%)  1/130 (0.77%)  0/4 (0.00%) 
Investigations           
Neutrophil count decreased † 1  16/50 (32.00%)  17/48 (35.42%)  12/21 (57.14%)  21/130 (16.15%)  0/4 (0.00%) 
White blood cell count decreased † 1  12/50 (24.00%)  15/48 (31.25%)  13/21 (61.90%)  20/130 (15.38%)  0/4 (0.00%) 
Platelet count decreased † 1  8/50 (16.00%)  11/48 (22.92%)  7/21 (33.33%)  16/130 (12.31%)  0/4 (0.00%) 
Aspartate aminotransferase increased † 1  9/50 (18.00%)  5/48 (10.42%)  7/21 (33.33%)  14/130 (10.77%)  0/4 (0.00%) 
Alanine aminotransferase increased † 1  7/50 (14.00%)  4/48 (8.33%)  7/21 (33.33%)  10/130 (7.69%)  0/4 (0.00%) 
Lymphocyte count decreased † 1  3/50 (6.00%)  5/48 (10.42%)  2/21 (9.52%)  11/130 (8.46%)  0/4 (0.00%) 
Weight decreased † 1  5/50 (10.00%)  6/48 (12.50%)  4/21 (19.05%)  6/130 (4.62%)  1/4 (25.00%) 
Blood bilirubin increased † 1  4/50 (8.00%)  3/48 (6.25%)  5/21 (23.81%)  7/130 (5.38%)  0/4 (0.00%) 
Blood alkaline phosphatase increased † 1  1/50 (2.00%)  4/48 (8.33%)  6/21 (28.57%)  7/130 (5.38%)  0/4 (0.00%) 
Electrocardiogram QT prolonged † 1  5/50 (10.00%)  0/48 (0.00%)  1/21 (4.76%)  3/130 (2.31%)  0/4 (0.00%) 
Blood lactate dehydrogenase increased † 1  4/50 (8.00%)  0/48 (0.00%)  3/21 (14.29%)  1/130 (0.77%)  0/4 (0.00%) 
Gamma-glutamyltransferase increased † 1  1/50 (2.00%)  6/48 (12.50%)  1/21 (4.76%)  4/130 (3.08%)  0/4 (0.00%) 
Troponin I increased † 1  3/50 (6.00%)  0/48 (0.00%)  0/21 (0.00%)  0/130 (0.00%)  0/4 (0.00%) 
Ejection fraction decreased † 1  1/50 (2.00%)  1/48 (2.08%)  0/21 (0.00%)  0/130 (0.00%)  1/4 (25.00%) 
Metabolism and nutrition disorders           
Decreased appetite † 1  15/50 (30.00%)  21/48 (43.75%)  6/21 (28.57%)  37/130 (28.46%)  1/4 (25.00%) 
Hypokalemia † 1  3/50 (6.00%)  3/48 (6.25%)  4/21 (19.05%)  16/130 (12.31%)  0/4 (0.00%) 
Hypoalbuminemia † 1  1/50 (2.00%)  3/48 (6.25%)  4/21 (19.05%)  5/130 (3.85%)  0/4 (0.00%) 
Hypomagnesemia † 1  2/50 (4.00%)  0/48 (0.00%)  3/21 (14.29%)  4/130 (3.08%)  0/4 (0.00%) 
Musculoskeletal and connective tissue disorders           
Back pain † 1  1/50 (2.00%)  2/48 (4.17%)  3/21 (14.29%)  14/130 (10.77%)  0/4 (0.00%) 
Arthralgia † 1  3/50 (6.00%)  3/48 (6.25%)  1/21 (4.76%)  8/130 (6.15%)  0/4 (0.00%) 
Myalgia † 1  4/50 (8.00%)  3/48 (6.25%)  0/21 (0.00%)  7/130 (5.38%)  0/4 (0.00%) 
Muscle spasms † 1  1/50 (2.00%)  1/48 (2.08%)  1/21 (4.76%)  8/130 (6.15%)  0/4 (0.00%) 
Pain in extremity † 1  2/50 (4.00%)  4/48 (8.33%)  2/21 (9.52%)  3/130 (2.31%)  0/4 (0.00%) 
Neck pain † 1  0/50 (0.00%)  1/48 (2.08%)  2/21 (9.52%)  1/130 (0.77%)  0/4 (0.00%) 
Nervous system disorders           
Headache † 1  7/50 (14.00%)  10/48 (20.83%)  2/21 (9.52%)  26/130 (20.00%)  1/4 (25.00%) 
Dysgeusia † 1  4/50 (8.00%)  5/48 (10.42%)  1/21 (4.76%)  8/130 (6.15%)  1/4 (25.00%) 
Peripheral sensory neuropathy † 1  3/50 (6.00%)  4/48 (8.33%)  2/21 (9.52%)  9/130 (6.92%)  0/4 (0.00%) 
Neuropathy peripheral † 1  2/50 (4.00%)  1/48 (2.08%)  2/21 (9.52%)  7/130 (5.38%)  1/4 (25.00%) 
Cognitive disorder † 1  0/50 (0.00%)  0/48 (0.00%)  0/21 (0.00%)  0/130 (0.00%)  1/4 (25.00%) 
Psychiatric disorders           
Insomnia † 1  5/50 (10.00%)  5/48 (10.42%)  5/21 (23.81%)  6/130 (4.62%)  0/4 (0.00%) 
Anxiety † 1  3/50 (6.00%)  2/48 (4.17%)  2/21 (9.52%)  7/130 (5.38%)  0/4 (0.00%) 
Dizziness † 1  6/50 (12.00%)  4/48 (8.33%)  1/21 (4.76%)  9/130 (6.92%)  1/4 (25.00%) 
Renal and urinary disorders           
Hematuria † 1  0/50 (0.00%)  1/48 (2.08%)  1/21 (4.76%)  1/130 (0.77%)  1/4 (25.00%) 
Respiratory, thoracic and mediastinal disorders           
Cough † 1  9/50 (18.00%)  7/48 (14.58%)  4/21 (19.05%)  23/130 (17.69%)  0/4 (0.00%) 
Dyspnea † 1  5/50 (10.00%)  0/48 (0.00%)  2/21 (9.52%)  19/130 (14.62%)  0/4 (0.00%) 
Epistaxis † 1  6/50 (12.00%)  3/48 (6.25%)  1/21 (4.76%)  16/130 (12.31%)  0/4 (0.00%) 
Pneumonitis † 1  4/50 (8.00%)  1/48 (2.08%)  2/21 (9.52%)  5/130 (3.85%)  0/4 (0.00%) 
Interstitial lung disease † 1  4/50 (8.00%)  3/48 (6.25%)  5/21 (23.81%)  1/130 (0.77%)  0/4 (0.00%) 
Hypoxia † 1  0/50 (0.00%)  0/48 (0.00%)  1/21 (4.76%)  2/130 (1.54%)  1/4 (25.00%) 
Skin and subcutaneous tissue disorders           
Alopecia † 1  25/50 (50.00%)  28/48 (58.33%)  8/21 (38.10%)  61/130 (46.92%)  2/4 (50.00%) 
Rash † 1  1/50 (2.00%)  6/48 (12.50%)  1/21 (4.76%)  10/130 (7.69%)  0/4 (0.00%) 
Dry skin † 1  2/50 (4.00%)  1/48 (2.08%)  1/21 (4.76%)  7/130 (5.38%)  0/4 (0.00%) 
Nail disorder † 1  1/50 (2.00%)  0/48 (0.00%)  0/21 (0.00%)  7/130 (5.38%)  0/4 (0.00%) 
Skin hyperpigmentation † 1  3/50 (6.00%)  0/48 (0.00%)  2/21 (9.52%)  4/130 (3.08%)  0/4 (0.00%) 
Pruritus † 1  0/50 (0.00%)  3/48 (6.25%)  0/21 (0.00%)  4/130 (3.08%)  0/4 (0.00%) 
Vascular disorders           
Hypertension † 1  0/50 (0.00%)  0/48 (0.00%)  0/21 (0.00%)  4/130 (3.08%)  1/4 (25.00%) 
1
Term from vocabulary, MedDRA v20.1
†
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: 1-908-992-6400
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: NCT03248492    
Other Study ID Numbers: DS8201-A-U201
2016-004986-18 ( EudraCT Number )
JapicCTI-173693(en) ( Registry Identifier: JapicCTI )
DESTINY-Breast01 ( Other Identifier: Daiichi Sankyo and AstraZeneca )
First Submitted: August 10, 2017
First Posted: August 14, 2017
Results First Submitted: January 17, 2020
Results First Posted: February 17, 2020
Last Update Posted: November 15, 2023