Trial Outcomes & Findings for A Study to Assess the Efficacy and Safety of Enzalutamide With Trastuzumab in Patients With Human Epidermal Growth Factor Receptor 2 Positive (HER2+), Androgen Receptor Positive (AR+) Metastatic or Locally Advanced Breast Cancer (NCT NCT02091960)
NCT ID: NCT02091960
Last Updated: 2025-04-04
Results Overview
Clinical benefit rate was defined as the percentage of evaluable participants with best objective response of confirmed complete response or partial response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, or prolonged stable disease (≥ 24 weeks). Complete response (CR) was defined as the disappearance of all target and non-target lesions and no new lesions, and lymph nodes all \< 10 mm in short axis. Partial response (PR) was defined as disappearance of target lesions or a ≥ 30% decrease in the size of target lesions, with persistence of non-target lesions and no new lesions. Stable disease (SD) was defined as \< 30% decrease and \< 20% increase in the size of target lesions, persistence of non-target lesions, and no new lesions. PR and CR required confirmation with equivalent or improved assessment no less than 4 weeks after the date that PR or CR was first observed. SD required confirmation with equivalent or improved assessment no less than 8 weeks after enrollment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
103 participants
Primary outcome timeframe
Tumor assessments were performed every 8 weeks through week 49, and then every 12 weeks thereafter until disease progression or death; the median duration of treatment was 70 days, and the maximum was 660 days.
Results posted on
2025-04-04
Participant Flow
The study was conducted at 35 clinical sites in Belgium, Canada, Italy, Spain, the United Kingdom and the United States.
This study enrolled women with human epidermal growth factor receptor 2 positive (HER2+) and androgen receptor positive (AR+) metastatic or locally advanced breast cancer who progressed on anti-HER2 therapy in the metastatic or advanced setting.
Participant milestones
| Measure |
Enzalutamide + Trastuzumab
Participants received 160 mg enzalutamide orally once daily and 6 mg/kg trastuzumab administered by intravenous infusion or subcutaneous injection every 21 days. Participants continued on treatment until disease progression, unacceptable toxicity or any other discontinuation criteria were met.
|
|---|---|
|
Overall Study
STARTED
|
103
|
|
Overall Study
Received Treatment
|
103
|
|
Overall Study
COMPLETED
|
58
|
|
Overall Study
NOT COMPLETED
|
45
|
Reasons for withdrawal
| Measure |
Enzalutamide + Trastuzumab
Participants received 160 mg enzalutamide orally once daily and 6 mg/kg trastuzumab administered by intravenous infusion or subcutaneous injection every 21 days. Participants continued on treatment until disease progression, unacceptable toxicity or any other discontinuation criteria were met.
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|---|---|
|
Overall Study
Death
|
7
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Miscellaneous Reasons
|
37
|
Baseline Characteristics
Participants for whom data were available
Baseline characteristics by cohort
| Measure |
Enzalutamide + Trastuzumab
n=103 Participants
Participants received 160 mg enzalutamide orally once daily and 6 mg/kg trastuzumab administered by intravenous infusion or subcutaneous injection every 21 days. Participants continued on treatment until disease progression, unacceptable toxicity or any other discontinuation criteria were met.
|
|---|---|
|
Age, Continuous
|
59.3 years
STANDARD_DEVIATION 10.0 • n=103 Participants
|
|
Sex: Female, Male
Female
|
103 Participants
n=103 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=103 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=103 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
98 Participants
n=103 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=103 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
90 Participants
n=103 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
8 Participants
n=103 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
3 Participants
n=103 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaskan Native
|
0 Participants
n=103 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or other Pacific Islander
|
1 Participants
n=103 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=103 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 0
|
51 Participants
n=103 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 1
|
51 Participants
n=103 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Missing
|
1 Participants
n=103 Participants
|
|
Time from Initial Diagnosis of Primary Cancer to Enrollment
|
1199 days
n=95 Participants • Participants for whom data were available
|
|
Histopathology at Diagnosis
Ductal
|
73 Participants
n=103 Participants
|
|
Histopathology at Diagnosis
Inflammatory
|
5 Participants
n=103 Participants
|
|
Histopathology at Diagnosis
Intraductal
|
6 Participants
n=103 Participants
|
|
Histopathology at Diagnosis
Lobular
|
6 Participants
n=103 Participants
|
|
Histopathology at Diagnosis
Mixed
|
1 Participants
n=103 Participants
|
|
Histopathology at Diagnosis
Not otherwise specified
|
1 Participants
n=103 Participants
|
|
Histopathology at Diagnosis
Other
|
5 Participants
n=103 Participants
|
|
Histopathology at Diagnosis
Unknown
|
6 Participants
n=103 Participants
|
|
Anatomic Stage
Stage 0
|
3 Participants
n=103 Participants
|
|
Anatomic Stage
Stage IA
|
6 Participants
n=103 Participants
|
|
Anatomic Stage
Stage IB
|
1 Participants
n=103 Participants
|
|
Anatomic Stage
Stage IIA
|
14 Participants
n=103 Participants
|
|
Anatomic Stage
Stage IIB
|
12 Participants
n=103 Participants
|
|
Anatomic Stage
Stage IIIA
|
5 Participants
n=103 Participants
|
|
Anatomic Stage
Stage IIIB
|
7 Participants
n=103 Participants
|
|
Anatomic Stage
Stage IIIC
|
7 Participants
n=103 Participants
|
|
Anatomic Stage
Stage IV
|
28 Participants
n=103 Participants
|
|
Anatomic Stage
Unknown
|
20 Participants
n=103 Participants
|
PRIMARY outcome
Timeframe: Tumor assessments were performed every 8 weeks through week 49, and then every 12 weeks thereafter until disease progression or death; the median duration of treatment was 70 days, and the maximum was 660 days.Population: The efficacy evaluable set (EES) included all enrolled participants who had centrally assessed androgen receptor positive (AR+; defined as ≥ 10% of tumor cells with nuclear expression), received at least one dose of study drug, and had at least one available post baseline tumor assessment.
Clinical benefit rate was defined as the percentage of evaluable participants with best objective response of confirmed complete response or partial response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, or prolonged stable disease (≥ 24 weeks). Complete response (CR) was defined as the disappearance of all target and non-target lesions and no new lesions, and lymph nodes all \< 10 mm in short axis. Partial response (PR) was defined as disappearance of target lesions or a ≥ 30% decrease in the size of target lesions, with persistence of non-target lesions and no new lesions. Stable disease (SD) was defined as \< 30% decrease and \< 20% increase in the size of target lesions, persistence of non-target lesions, and no new lesions. PR and CR required confirmation with equivalent or improved assessment no less than 4 weeks after the date that PR or CR was first observed. SD required confirmation with equivalent or improved assessment no less than 8 weeks after enrollment.
Outcome measures
| Measure |
Enzalutamide + Trastuzumab
n=89 Participants
Participants received 160 mg enzalutamide orally once daily and 6 mg/kg trastuzumab administered by intravenous infusion or subcutaneous injection every 21 days. Participants continued on treatment until disease progression, unacceptable toxicity or any other discontinuation criteria were met.
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|---|---|
|
Clinical Benefit Rate (CBR)
|
23.6 percentage of participants
Interval 15.2 to 33.8
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Efficacy evaluable set
Overall response rate was defined as the percentage of evaluable participants with a best objective response of confirmed complete response (CR) or partial response (PR) per RECIST 1.1. Complete response was defined as the disappearance of all target and non-target lesions and no new lesions, and lymph nodes all \< 10 mm in short axis. Partial response was defined as disappearance of target lesions or a ≥ 30% decrease in the size of target lesions with persistence of non-target lesions and no new lesions. PR and CR required confirmation with equivalent or improved assessment no less than 4 weeks after the date of scan that PR or CR was first observed.
Outcome measures
| Measure |
Enzalutamide + Trastuzumab
n=89 Participants
Participants received 160 mg enzalutamide orally once daily and 6 mg/kg trastuzumab administered by intravenous infusion or subcutaneous injection every 21 days. Participants continued on treatment until disease progression, unacceptable toxicity or any other discontinuation criteria were met.
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|---|---|
|
Overall Response Rate at Week 24
|
3.4 percentage of participants
Interval 0.7 to 9.5
|
SECONDARY outcome
Timeframe: Tumor assessments were performed every 8 weeks through week 49, and then every 12 weeks thereafter until disease progression or death; the median duration of treatment was 70 days, and the maximum was 660 days.Population: Efficacy evaluable set
Best overall response was the best response across all time points, based on investigator assessments. Best overall response rate was defined as the percentage of evaluable participants with a best objective response of confirmed complete response (CR) or partial response (PR) at any time during the study per RECIST 1.1. Complete response was defined as the disappearance of all target and non-target lesions and no new lesions, and lymph nodes all \< 10 mm in short axis. Partial response was defined as disappearance of target lesions or a ≥ 30% decrease in the size of target lesions with persistence of non-target lesions and no new lesions. PR and CR required confirmation with equivalent or improved assessment no less than 4 weeks after the date of scan that PR or CR was first observed.
Outcome measures
| Measure |
Enzalutamide + Trastuzumab
n=89 Participants
Participants received 160 mg enzalutamide orally once daily and 6 mg/kg trastuzumab administered by intravenous infusion or subcutaneous injection every 21 days. Participants continued on treatment until disease progression, unacceptable toxicity or any other discontinuation criteria were met.
|
|---|---|
|
Best Overall Response Rate
|
4.5 percentage of participants
Interval 1.2 to 11.1
|
SECONDARY outcome
Timeframe: From the date of first dose of study drug until disease progression or death; the median duration of treatment was 70 days, and the maximum was 660 days.Population: Efficacy evaluable set
Progression-free survival was defined as the time from the date of first dose of enzalutamide until the date of disease progression per RECIST 1.1, or death from any cause on study, whichever occurred first. Participants who initiated another antitumor therapy before documented progressive disease (PD) or death, or who progressed or died after missing 2 or more consecutive radiological assessments were censored at the date of the last radiological assessment showing no progression. Progressive disease was defined as a ≥ 20% increase in the size of target lesions and at least a 5 mm increase in size of target lesions from smallest size on study, or unequivocal progression of non-target lesions, or any new lesions.
Outcome measures
| Measure |
Enzalutamide + Trastuzumab
n=89 Participants
Participants received 160 mg enzalutamide orally once daily and 6 mg/kg trastuzumab administered by intravenous infusion or subcutaneous injection every 21 days. Participants continued on treatment until disease progression, unacceptable toxicity or any other discontinuation criteria were met.
|
|---|---|
|
Progression-free Survival
|
105.0 days
Interval 61.0 to 116.0
|
SECONDARY outcome
Timeframe: From the date of first dose of study drug until disease progression or death; the median duration of treatment was 70 days, and the maximum was 660 days.Population: Efficacy analysis set
Time to progression was defined as the time from the first date of enzalutamide treatment until the date of disease progression per RECIST 1.1. Participants who initiated another anti-tumor therapy before documented PD, who progressed after missing two or more consecutive radiological assessments or who died before disease progression were censored at the date of the last radiological assessment showing no progression.
Outcome measures
| Measure |
Enzalutamide + Trastuzumab
n=89 Participants
Participants received 160 mg enzalutamide orally once daily and 6 mg/kg trastuzumab administered by intravenous infusion or subcutaneous injection every 21 days. Participants continued on treatment until disease progression, unacceptable toxicity or any other discontinuation criteria were met.
|
|---|---|
|
Time to Progression
|
108.0 days
Interval 61.0 to 116.0
|
SECONDARY outcome
Timeframe: Tumor assessments were performed every 8 weeks through week 49, and then every 12 weeks thereafter until disease progression or death; the median duration of treatment was 70 days, and the maximum was 660 days..Population: Efficacy evaluable set participants with a best overall response of CR or PR
Duration of response was defined as the time from the date of first documentation of response (CR or PR) until the date of disease progression per RECIST 1.1. Participants who initiated another anti-tumor therapy before documented PD, progressed after missing two or more consecutive radiological assessments or who died before disease progression were censored at the date of the last radiological assessment showing no progression.
Outcome measures
| Measure |
Enzalutamide + Trastuzumab
n=4 Participants
Participants received 160 mg enzalutamide orally once daily and 6 mg/kg trastuzumab administered by intravenous infusion or subcutaneous injection every 21 days. Participants continued on treatment until disease progression, unacceptable toxicity or any other discontinuation criteria were met.
|
|---|---|
|
Duration of Response
|
NA days
Could not be estimated due to the low number of events
|
SECONDARY outcome
Timeframe: From the date of first dose of study drug until disease progression or death; the median duration of treatment was 70 days, and the maximum was 660 days.Population: Efficacy evaluable set with a best overall response of CR or PR
Time to response was defined as the time from the first date of enzalutamide treatment to initial CR or PR and was calculated for participants with a CR or PR.
Outcome measures
| Measure |
Enzalutamide + Trastuzumab
n=4 Participants
Participants received 160 mg enzalutamide orally once daily and 6 mg/kg trastuzumab administered by intravenous infusion or subcutaneous injection every 21 days. Participants continued on treatment until disease progression, unacceptable toxicity or any other discontinuation criteria were met.
|
|---|---|
|
Time to Response
|
57 days
Interval 57.0 to 222.0
|
SECONDARY outcome
Timeframe: From the first dose date of study drug to 30 days after the last dose date of study drug or the start of subsequent treatment or date of death, whichever was first (Up to 3031 days)Population: The Safety Analysis Set (SAF) which consisted of all participants who had received at least 1 or partial dose of study drug.
An AE was defined as any untoward medical occurrence in a participant administered study drug/who underwent study procedures and did not necessarily have a causal relationship with treatment. Abnormalities identified during medical tests were defined as an AE if they induced clinical signs/symptoms, required active intervention, interruption or discontinuation of study medication, or were clinically significant to the investigator. An AE was defined as serious if any of the following resulted: Death, was life-threatening, persistent or significant disability/incapacity or substantial disruption of ability to conduct normal life functions, congenital anomaly/ birth defect, inpatient hospitalization/prolongation of hospitalization or other medically important event. TEAE was defined as an AE observed during the treatment emergent period, which is from first dose date of study drug to 30 days after last dose date or the start of subsequent treatment or date of death, whichever is first.
Outcome measures
| Measure |
Enzalutamide + Trastuzumab
n=103 Participants
Participants received 160 mg enzalutamide orally once daily and 6 mg/kg trastuzumab administered by intravenous infusion or subcutaneous injection every 21 days. Participants continued on treatment until disease progression, unacceptable toxicity or any other discontinuation criteria were met.
|
|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any treatment emergent adverse events (TEAE)
|
97 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Enzalutamide Related TEAE
|
75 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Trastuzumab Related TEAE
|
40 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any Drug Related TEAE
|
78 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Deaths
|
4 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Serious TEAE
|
24 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Enzalutamide Related Serious TEAE
|
3 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Trastuzumab Related Serious TEAE
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any Drug Related Serious TEAE
|
3 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
TEAE leading to discontinuation of enzalutamide
|
23 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
TEAE leading to discontinuation of trastuzumab
|
21 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
TEAE leading to discontinuation of any study drug
|
24 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Discontinuation due to enzalutamide Related TEAE
|
5 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Discontinuation due to trastuzumab Related TEAE
|
5 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Discontinuation due to Any Drug Related TEAE
|
9 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
TEAE Leading to Dose Reduction
|
7 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
TEAE Leading to Dose Interruption
|
23 Participants
|
Adverse Events
Enzalutamide + Trastuzumab
Serious events: 24 serious events
Other events: 89 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Enzalutamide + Trastuzumab
n=103 participants at risk
Participants received 160 mg enzalutamide orally once daily and 6 mg/kg trastuzumab administered by intravenous infusion or subcutaneous injection every 21 days. Participants continued on treatment until disease progression, unacceptable toxicity or any other discontinuation criteria were met.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
1.9%
2/103 • Number of events 2 • From the first dose date of study drug to 30 days after the last dose date of study drug or the start of subsequent treatment or date of death, whichever is first (Up to 3031 days).
The Safety Analysis Set consisted of all participants who had received at least 1 or partial dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.97%
1/103 • Number of events 1 • From the first dose date of study drug to 30 days after the last dose date of study drug or the start of subsequent treatment or date of death, whichever is first (Up to 3031 days).
The Safety Analysis Set consisted of all participants who had received at least 1 or partial dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.97%
1/103 • Number of events 1 • From the first dose date of study drug to 30 days after the last dose date of study drug or the start of subsequent treatment or date of death, whichever is first (Up to 3031 days).
The Safety Analysis Set consisted of all participants who had received at least 1 or partial dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
2.9%
3/103 • Number of events 4 • From the first dose date of study drug to 30 days after the last dose date of study drug or the start of subsequent treatment or date of death, whichever is first (Up to 3031 days).
The Safety Analysis Set consisted of all participants who had received at least 1 or partial dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
2.9%
3/103 • Number of events 4 • From the first dose date of study drug to 30 days after the last dose date of study drug or the start of subsequent treatment or date of death, whichever is first (Up to 3031 days).
The Safety Analysis Set consisted of all participants who had received at least 1 or partial dose of study drug.
|
|
General disorders
Asthenia
|
0.97%
1/103 • Number of events 1 • From the first dose date of study drug to 30 days after the last dose date of study drug or the start of subsequent treatment or date of death, whichever is first (Up to 3031 days).
The Safety Analysis Set consisted of all participants who had received at least 1 or partial dose of study drug.
|
|
General disorders
General physical health deterioration
|
0.97%
1/103 • Number of events 1 • From the first dose date of study drug to 30 days after the last dose date of study drug or the start of subsequent treatment or date of death, whichever is first (Up to 3031 days).
The Safety Analysis Set consisted of all participants who had received at least 1 or partial dose of study drug.
|
|
General disorders
Pyrexia
|
0.97%
1/103 • Number of events 1 • From the first dose date of study drug to 30 days after the last dose date of study drug or the start of subsequent treatment or date of death, whichever is first (Up to 3031 days).
The Safety Analysis Set consisted of all participants who had received at least 1 or partial dose of study drug.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.97%
1/103 • Number of events 1 • From the first dose date of study drug to 30 days after the last dose date of study drug or the start of subsequent treatment or date of death, whichever is first (Up to 3031 days).
The Safety Analysis Set consisted of all participants who had received at least 1 or partial dose of study drug.
|
|
Infections and infestations
Infection
|
0.97%
1/103 • Number of events 2 • From the first dose date of study drug to 30 days after the last dose date of study drug or the start of subsequent treatment or date of death, whichever is first (Up to 3031 days).
The Safety Analysis Set consisted of all participants who had received at least 1 or partial dose of study drug.
|
|
Infections and infestations
Pneumonia
|
1.9%
2/103 • Number of events 2 • From the first dose date of study drug to 30 days after the last dose date of study drug or the start of subsequent treatment or date of death, whichever is first (Up to 3031 days).
The Safety Analysis Set consisted of all participants who had received at least 1 or partial dose of study drug.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.97%
1/103 • Number of events 1 • From the first dose date of study drug to 30 days after the last dose date of study drug or the start of subsequent treatment or date of death, whichever is first (Up to 3031 days).
The Safety Analysis Set consisted of all participants who had received at least 1 or partial dose of study drug.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.97%
1/103 • Number of events 1 • From the first dose date of study drug to 30 days after the last dose date of study drug or the start of subsequent treatment or date of death, whichever is first (Up to 3031 days).
The Safety Analysis Set consisted of all participants who had received at least 1 or partial dose of study drug.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.97%
1/103 • Number of events 1 • From the first dose date of study drug to 30 days after the last dose date of study drug or the start of subsequent treatment or date of death, whichever is first (Up to 3031 days).
The Safety Analysis Set consisted of all participants who had received at least 1 or partial dose of study drug.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.97%
1/103 • Number of events 1 • From the first dose date of study drug to 30 days after the last dose date of study drug or the start of subsequent treatment or date of death, whichever is first (Up to 3031 days).
The Safety Analysis Set consisted of all participants who had received at least 1 or partial dose of study drug.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.97%
1/103 • Number of events 2 • From the first dose date of study drug to 30 days after the last dose date of study drug or the start of subsequent treatment or date of death, whichever is first (Up to 3031 days).
The Safety Analysis Set consisted of all participants who had received at least 1 or partial dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.9%
3/103 • Number of events 3 • From the first dose date of study drug to 30 days after the last dose date of study drug or the start of subsequent treatment or date of death, whichever is first (Up to 3031 days).
The Safety Analysis Set consisted of all participants who had received at least 1 or partial dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm malignant
|
0.97%
1/103 • Number of events 1 • From the first dose date of study drug to 30 days after the last dose date of study drug or the start of subsequent treatment or date of death, whichever is first (Up to 3031 days).
The Safety Analysis Set consisted of all participants who had received at least 1 or partial dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
4.9%
5/103 • Number of events 6 • From the first dose date of study drug to 30 days after the last dose date of study drug or the start of subsequent treatment or date of death, whichever is first (Up to 3031 days).
The Safety Analysis Set consisted of all participants who had received at least 1 or partial dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to skin
|
0.97%
1/103 • Number of events 1 • From the first dose date of study drug to 30 days after the last dose date of study drug or the start of subsequent treatment or date of death, whichever is first (Up to 3031 days).
The Safety Analysis Set consisted of all participants who had received at least 1 or partial dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myxoid liposarcoma
|
0.97%
1/103 • Number of events 1 • From the first dose date of study drug to 30 days after the last dose date of study drug or the start of subsequent treatment or date of death, whichever is first (Up to 3031 days).
The Safety Analysis Set consisted of all participants who had received at least 1 or partial dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.97%
1/103 • Number of events 1 • From the first dose date of study drug to 30 days after the last dose date of study drug or the start of subsequent treatment or date of death, whichever is first (Up to 3031 days).
The Safety Analysis Set consisted of all participants who had received at least 1 or partial dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin neoplasm bleeding
|
0.97%
1/103 • Number of events 1 • From the first dose date of study drug to 30 days after the last dose date of study drug or the start of subsequent treatment or date of death, whichever is first (Up to 3031 days).
The Safety Analysis Set consisted of all participants who had received at least 1 or partial dose of study drug.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.97%
1/103 • Number of events 1 • From the first dose date of study drug to 30 days after the last dose date of study drug or the start of subsequent treatment or date of death, whichever is first (Up to 3031 days).
The Safety Analysis Set consisted of all participants who had received at least 1 or partial dose of study drug.
|
|
Renal and urinary disorders
Urinary retention
|
0.97%
1/103 • Number of events 1 • From the first dose date of study drug to 30 days after the last dose date of study drug or the start of subsequent treatment or date of death, whichever is first (Up to 3031 days).
The Safety Analysis Set consisted of all participants who had received at least 1 or partial dose of study drug.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.97%
1/103 • Number of events 1 • From the first dose date of study drug to 30 days after the last dose date of study drug or the start of subsequent treatment or date of death, whichever is first (Up to 3031 days).
The Safety Analysis Set consisted of all participants who had received at least 1 or partial dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.9%
2/103 • Number of events 2 • From the first dose date of study drug to 30 days after the last dose date of study drug or the start of subsequent treatment or date of death, whichever is first (Up to 3031 days).
The Safety Analysis Set consisted of all participants who had received at least 1 or partial dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.97%
1/103 • Number of events 1 • From the first dose date of study drug to 30 days after the last dose date of study drug or the start of subsequent treatment or date of death, whichever is first (Up to 3031 days).
The Safety Analysis Set consisted of all participants who had received at least 1 or partial dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.97%
1/103 • Number of events 1 • From the first dose date of study drug to 30 days after the last dose date of study drug or the start of subsequent treatment or date of death, whichever is first (Up to 3031 days).
The Safety Analysis Set consisted of all participants who had received at least 1 or partial dose of study drug.
|
|
Vascular disorders
Embolism
|
0.97%
1/103 • Number of events 1 • From the first dose date of study drug to 30 days after the last dose date of study drug or the start of subsequent treatment or date of death, whichever is first (Up to 3031 days).
The Safety Analysis Set consisted of all participants who had received at least 1 or partial dose of study drug.
|
Other adverse events
| Measure |
Enzalutamide + Trastuzumab
n=103 participants at risk
Participants received 160 mg enzalutamide orally once daily and 6 mg/kg trastuzumab administered by intravenous infusion or subcutaneous injection every 21 days. Participants continued on treatment until disease progression, unacceptable toxicity or any other discontinuation criteria were met.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
8.7%
9/103 • Number of events 10 • From the first dose date of study drug to 30 days after the last dose date of study drug or the start of subsequent treatment or date of death, whichever is first (Up to 3031 days).
The Safety Analysis Set consisted of all participants who had received at least 1 or partial dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
14.6%
15/103 • Number of events 16 • From the first dose date of study drug to 30 days after the last dose date of study drug or the start of subsequent treatment or date of death, whichever is first (Up to 3031 days).
The Safety Analysis Set consisted of all participants who had received at least 1 or partial dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
13.6%
14/103 • Number of events 16 • From the first dose date of study drug to 30 days after the last dose date of study drug or the start of subsequent treatment or date of death, whichever is first (Up to 3031 days).
The Safety Analysis Set consisted of all participants who had received at least 1 or partial dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
9.7%
10/103 • Number of events 10 • From the first dose date of study drug to 30 days after the last dose date of study drug or the start of subsequent treatment or date of death, whichever is first (Up to 3031 days).
The Safety Analysis Set consisted of all participants who had received at least 1 or partial dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
27.2%
28/103 • Number of events 33 • From the first dose date of study drug to 30 days after the last dose date of study drug or the start of subsequent treatment or date of death, whichever is first (Up to 3031 days).
The Safety Analysis Set consisted of all participants who had received at least 1 or partial dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
9.7%
10/103 • Number of events 10 • From the first dose date of study drug to 30 days after the last dose date of study drug or the start of subsequent treatment or date of death, whichever is first (Up to 3031 days).
The Safety Analysis Set consisted of all participants who had received at least 1 or partial dose of study drug.
|
|
General disorders
Asthenia
|
5.8%
6/103 • Number of events 6 • From the first dose date of study drug to 30 days after the last dose date of study drug or the start of subsequent treatment or date of death, whichever is first (Up to 3031 days).
The Safety Analysis Set consisted of all participants who had received at least 1 or partial dose of study drug.
|
|
General disorders
Fatigue
|
35.9%
37/103 • Number of events 60 • From the first dose date of study drug to 30 days after the last dose date of study drug or the start of subsequent treatment or date of death, whichever is first (Up to 3031 days).
The Safety Analysis Set consisted of all participants who had received at least 1 or partial dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
14.6%
15/103 • Number of events 16 • From the first dose date of study drug to 30 days after the last dose date of study drug or the start of subsequent treatment or date of death, whichever is first (Up to 3031 days).
The Safety Analysis Set consisted of all participants who had received at least 1 or partial dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.6%
13/103 • Number of events 19 • From the first dose date of study drug to 30 days after the last dose date of study drug or the start of subsequent treatment or date of death, whichever is first (Up to 3031 days).
The Safety Analysis Set consisted of all participants who had received at least 1 or partial dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.6%
15/103 • Number of events 16 • From the first dose date of study drug to 30 days after the last dose date of study drug or the start of subsequent treatment or date of death, whichever is first (Up to 3031 days).
The Safety Analysis Set consisted of all participants who had received at least 1 or partial dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.8%
7/103 • Number of events 8 • From the first dose date of study drug to 30 days after the last dose date of study drug or the start of subsequent treatment or date of death, whichever is first (Up to 3031 days).
The Safety Analysis Set consisted of all participants who had received at least 1 or partial dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.8%
6/103 • Number of events 7 • From the first dose date of study drug to 30 days after the last dose date of study drug or the start of subsequent treatment or date of death, whichever is first (Up to 3031 days).
The Safety Analysis Set consisted of all participants who had received at least 1 or partial dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.8%
6/103 • Number of events 7 • From the first dose date of study drug to 30 days after the last dose date of study drug or the start of subsequent treatment or date of death, whichever is first (Up to 3031 days).
The Safety Analysis Set consisted of all participants who had received at least 1 or partial dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.6%
13/103 • Number of events 14 • From the first dose date of study drug to 30 days after the last dose date of study drug or the start of subsequent treatment or date of death, whichever is first (Up to 3031 days).
The Safety Analysis Set consisted of all participants who had received at least 1 or partial dose of study drug.
|
|
Nervous system disorders
Dizziness
|
13.6%
14/103 • Number of events 16 • From the first dose date of study drug to 30 days after the last dose date of study drug or the start of subsequent treatment or date of death, whichever is first (Up to 3031 days).
The Safety Analysis Set consisted of all participants who had received at least 1 or partial dose of study drug.
|
|
Nervous system disorders
Headache
|
16.5%
17/103 • Number of events 19 • From the first dose date of study drug to 30 days after the last dose date of study drug or the start of subsequent treatment or date of death, whichever is first (Up to 3031 days).
The Safety Analysis Set consisted of all participants who had received at least 1 or partial dose of study drug.
|
|
Nervous system disorders
Restless legs syndrome
|
6.8%
7/103 • Number of events 7 • From the first dose date of study drug to 30 days after the last dose date of study drug or the start of subsequent treatment or date of death, whichever is first (Up to 3031 days).
The Safety Analysis Set consisted of all participants who had received at least 1 or partial dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
8.7%
9/103 • Number of events 12 • From the first dose date of study drug to 30 days after the last dose date of study drug or the start of subsequent treatment or date of death, whichever is first (Up to 3031 days).
The Safety Analysis Set consisted of all participants who had received at least 1 or partial dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.7%
10/103 • Number of events 10 • From the first dose date of study drug to 30 days after the last dose date of study drug or the start of subsequent treatment or date of death, whichever is first (Up to 3031 days).
The Safety Analysis Set consisted of all participants who had received at least 1 or partial dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.6%
15/103 • Number of events 16 • From the first dose date of study drug to 30 days after the last dose date of study drug or the start of subsequent treatment or date of death, whichever is first (Up to 3031 days).
The Safety Analysis Set consisted of all participants who had received at least 1 or partial dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.7%
9/103 • Number of events 13 • From the first dose date of study drug to 30 days after the last dose date of study drug or the start of subsequent treatment or date of death, whichever is first (Up to 3031 days).
The Safety Analysis Set consisted of all participants who had received at least 1 or partial dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.8%
6/103 • Number of events 6 • From the first dose date of study drug to 30 days after the last dose date of study drug or the start of subsequent treatment or date of death, whichever is first (Up to 3031 days).
The Safety Analysis Set consisted of all participants who had received at least 1 or partial dose of study drug.
|
|
Vascular disorders
Hot flush
|
16.5%
17/103 • Number of events 18 • From the first dose date of study drug to 30 days after the last dose date of study drug or the start of subsequent treatment or date of death, whichever is first (Up to 3031 days).
The Safety Analysis Set consisted of all participants who had received at least 1 or partial dose of study drug.
|
|
Vascular disorders
Hypertension
|
6.8%
7/103 • Number of events 9 • From the first dose date of study drug to 30 days after the last dose date of study drug or the start of subsequent treatment or date of death, whichever is first (Up to 3031 days).
The Safety Analysis Set consisted of all participants who had received at least 1 or partial dose of study drug.
|
Additional Information
Clinical Transparency
Astellas Global Development, Inc. (APGD)
Phone: 800-888-7704
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.
- Publication restrictions are in place
Restriction type: OTHER