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CompletedNCT02091960Updated Apr 4, 2025Results posted

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

A Phase 2 interventional study of Enzalutamide and Trastuzumab in HER2 Amplified, Advanced Breast Cancer and Human Epidermal Growth Factor Receptor 2 (HER2), sponsored by Astellas Pharma Global Development, Inc.. Completed at 39 sites in 6 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-04.

Sponsored by Astellas Pharma Global Development, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
103
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study summary

The purpose of this study was to evaluate the efficacy of enzalutamide with trastuzumab in patients with HER2+ AR+ metastatic or locally advanced breast cancer.

02

Conditions studied

  • HER2 Amplified
  • Advanced Breast Cancer
  • Human Epidermal Growth Factor Receptor 2 (HER2)

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Keywords

  • Enzalutamide
  • Trastuzumab
  • Breast cancer
  • HER2
  • Androgen receptor positive
  • Xtandi
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 103 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Astellas Pharma Global Development, Inc. is the lead sponsor of 204 studies on the registry; 25 are open to participants now.

Of its 80 completed or terminated interventional studies of FDA-regulated products, 38 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • The subject has histologically or cytologically proven adenocarcinoma of the breast that is HER2+
  • The subject has AR+ breast cancer
  • The subject has metastatic disease or has locally advanced disease that is not amendable to curative treatment
  • The subject has measurable disease or nonmeasurable, evaluable disease per RECIST 1.1. (NOTE: pleural effusions, ascites or other third fluid space are not evaluable diseases per RECIST 1.1).
  • The subject has received at least 1 line of therapy in the metastatic or locally advanced disease setting. The subject has been documented to have progressed by determination of the investigator on a regimen containing an anti-HER2 agent as the most recent regimen or the most recent anti-HER2 regimen was discontinued for any toxicity, with the exception of a cardiotoxicity.
  • The subject has adequately recovered from toxicities due to prior therapy.
  • The subject has an Eastern Cooperative Oncology Group performance (ECOG) status ≤ 1 at Screening and Day 1
  • The subject has available at the site a representative, formalin-fixed, paraffin-embedded, tumor specimen that enabled the definitive diagnosis of breast cancer with adequate viable tumor cells in a tissue block (preferred) or ≥ 10 (20 preferred) freshly cut, unstained, serial slides and the associated pathology report

Exclusion criteria

Exclusion Criteria:

  • The subject has a severe concurrent disease, infection, or comorbidity that would make the subject inappropriate for enrollment.
  • The subject has current or previously treated brain metastasis or active leptomeningeal disease. Brain imaging is required during screening in all subjects to exclude the presence of unequivocal central nervous system disease.

  • The subject has a history of a non-breast cancer malignancy with the following exceptions:

    • The subject with a previous history of a non-invasive carcinoma is eligible if he/she has had successful curative treatment any time prior to Screening.
    • For all other malignancies, the subject is eligible if they have undergone potentially curative therapy and they have been considered disease free for at least 5 years prior to Screening.
  • The subject has a history of seizure or any condition that may predispose to seizure (e.g., prior cortical stroke, significant brain trauma).
  • The subject has a history of loss of consciousness, cerebrovascular accident, or transient ischemic attack within 12 months before the Day 1 visit.
  • The subject has had a hypoglycemic episode requiring medical intervention while on insulin (or other anti-diabetic) treatment within 12 months before Day 1.
  • The subject had a major surgical procedure, substantial open biopsy, or significant traumatic experience within 28 days before the Day 1 visit, or anticipation of need for major surgical procedure during the course of the study.
  • The subject has had palliative radiation therapy to bone metastases within 14 days prior to the Day 1 visit (side effects from radiation must be resolved).
  • The subject has received chemotherapy, immunotherapy, or any other systemic anticancer therapy, with the exception of anti-HER2 therapy (e.g., trastuzumab), within 14 days prior to the Day 1 visit.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
103 participants (actual)

Study arms

  • Experimental
    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.

    Drug: Enzalutamide · Drug: Trastuzumab

Interventions

  • DrugEnzalutamide

    Capsules for oral administration

    Also known as: MDV3100, Xtandi

  • DrugTrastuzumab

    Intravenous infusion (IV) or subcutaneous injection if it is standard of care within a country

    Also known as: Herceptin

06

What researchers measure

Primary outcomes

  1. Clinical Benefit Rate (CBR)

    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.

    Time frame: 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.

Secondary outcomes

  1. Overall Response Rate at Week 24

    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.

    Time frame: 24 weeks

  2. Best Overall Response Rate

    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.

    Time frame: 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.

  3. Progression-free Survival

    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.

    Time frame: 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.

  4. Time to Progression

    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.

    Time frame: 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.

  5. Duration of Response

    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.

    Time frame: 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..

  6. Time to Response

    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.

    Time frame: 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.

  7. Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    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.

    Time frame: 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)

07

Results

Posted May 16, 2018

Participant flow

The study was conducted at 35 clinical sites in Belgium, Canada, Italy, Spain, the United Kingdom and the United States.

Participant flow — Overall Study
MilestoneEnzalutamide + Trastuzumab
Started103
Received treatment103
Completed58
Not completed45
Withdrew: Death7
Withdrew: Withdrawal by subject1
Withdrew: Miscellaneous reasons37

Outcome measures

PrimaryClinical Benefit Rate (CBR)

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.

Time frame:
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.
Reported as:
Number · percentage of participants
Clinical Benefit Rate (CBR)
percentage of participantsEnzalutamide + Trastuzumab
Clinical Benefit Rate (CBR)23.6 (15.2 to 33.8)
SecondaryOverall Response Rate at Week 24

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.

Time frame:
24 weeks
Reported as:
Number · percentage of participants
Overall Response Rate at Week 24
percentage of participantsEnzalutamide + Trastuzumab
Overall Response Rate at Week 243.4 (0.7 to 9.5)
SecondaryBest Overall Response Rate

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.

Time frame:
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.
Reported as:
Number · percentage of participants
Best Overall Response Rate
percentage of participantsEnzalutamide + Trastuzumab
Best Overall Response Rate4.5 (1.2 to 11.1)
SecondaryProgression-free Survival

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.

Time frame:
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.
Reported as:
Median · days
Progression-free Survival
daysEnzalutamide + Trastuzumab
Progression-free Survival105.0 (61 to 116)
SecondaryTime to Progression

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.

Time frame:
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.
Reported as:
Median · days
Time to Progression
daysEnzalutamide + Trastuzumab
Time to Progression108.0 (61 to 116)
SecondaryDuration of Response

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.

Time frame:
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..
Reported as:
Median · days
Duration of Response
daysEnzalutamide + Trastuzumab
Duration of ResponseNA (NA to NA)
SecondaryTime to Response

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.

Time frame:
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.
Reported as:
Median · days
Time to Response
daysEnzalutamide + Trastuzumab
Time to Response57 (57 to 222)
SecondaryNumber of Participants With Treatment Emergent Adverse Events (TEAEs)

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.

Time frame:
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)
Reported as:
Count of participants · Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
ParticipantsEnzalutamide + Trastuzumab
Any treatment emergent adverse events (TEAE)97
Enzalutamide Related TEAE75
Trastuzumab Related TEAE40
Any Drug Related TEAE78
Deaths4
Serious TEAE24
Enzalutamide Related Serious TEAE3
Trastuzumab Related Serious TEAE0
Any Drug Related Serious TEAE3
TEAE leading to discontinuation of enzalutamide23
TEAE leading to discontinuation of trastuzumab21
TEAE leading to discontinuation of any study drug24
Discontinuation due to enzalutamide Related TEAE5
Discontinuation due to trastuzumab Related TEAE5
Discontinuation due to Any Drug Related TEAE9
TEAE Leading to Dose Reduction7
TEAE Leading to Dose Interruption23

Adverse events

Collected over 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).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Enzalutamide + Trastuzumab7/103 (6.8%)24/103 (23.3%)89/103 (86.4%)
Most frequent serious events
Showing 10 of 30
Most frequent serious events
EventEnzalutamide + Trastuzumab
Malignant neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps)5/103
NauseaGastrointestinal disorders3/103
VomitingGastrointestinal disorders3/103
Back painMusculoskeletal and connective tissue disorders3/103
Abdominal painGastrointestinal disorders2/103
PneumoniaInfections and infestations2/103
DyspnoeaRespiratory, thoracic and mediastinal disorders2/103
DiarrhoeaGastrointestinal disorders1/103
DyspepsiaGastrointestinal disorders1/103
AstheniaGeneral disorders1/103
Most frequent other events
Showing 10 of 25
Most frequent other events
EventEnzalutamide + Trastuzumab
FatigueGeneral disorders37/103
NauseaGastrointestinal disorders28/103
HeadacheNervous system disorders17/103
Hot flushVascular disorders17/103
ConstipationGastrointestinal disorders15/103
Decreased appetiteMetabolism and nutrition disorders15/103
Back painMusculoskeletal and connective tissue disorders15/103
DyspnoeaRespiratory, thoracic and mediastinal disorders15/103
DiarrhoeaGastrointestinal disorders14/103
DizzinessNervous system disorders14/103

Baseline characteristics

Age, Continuous
Age, Continuous(years)Enzalutamide + Trastuzumab
Mean59.3 ± 10.0
Sex: Female, Male
Sex: Female, Male(Participants)Enzalutamide + Trastuzumab
Female103
Male0
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Enzalutamide + Trastuzumab
Hispanic or Latino5
Not Hispanic or Latino98
Unknown or Not Reported0
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Enzalutamide + Trastuzumab
Race — White90
Race — Black or African American8
Race — Asian3
Race — American Indian or Alaskan Native0
Race — Native Hawaiian or other Pacific Islander1
Race — Other1
Eastern Cooperative Oncology Group (ECOG) Performance Status
Eastern Cooperative Oncology Group (ECOG) Performance Status(Participants)Enzalutamide + Trastuzumab
Grade 051
Grade 151
Missing1
Time from Initial Diagnosis of Primary Cancer to Enrollment
Time from Initial Diagnosis of Primary Cancer to Enrollment(days)Enzalutamide + Trastuzumab
Median1199 (30 to 4713)
Histopathology at Diagnosis
Histopathology at Diagnosis(Participants)Enzalutamide + Trastuzumab
Ductal73
Inflammatory5
Intraductal6
Lobular6
Mixed1
Not otherwise specified1
Other5
Unknown6
Anatomic Stage
Anatomic Stage(Participants)Enzalutamide + Trastuzumab
Stage 03
Stage IA6
Stage IB1
Stage IIA14
Stage IIB12
Stage IIIA5
Stage IIIB7
Stage IIIC7
Stage IV28
Unknown20
08

Study locations

39 sites
  • Site US10051
    Anaheim, California 92801, United States
  • Site US10028
    Los Angeles, California 90048, United States
  • Site US10035
    San Francisco, California 94115, United States
  • Site US10079
    Fort Myers, Florida 33916, United States
  • Site US10074
    Gainesville, Florida 32605, United States
  • Site US10081
    Chicago, Illinois 60637, United States
  • Site US10004
    Indianapolis, Indiana 46202, United States
  • Site US10070
    Boston, Massachusetts 02215, United States
  • Site US10078
    Saint Louis, Missouri 63110, United States
  • Site US10072
    Cincinnati, Ohio 45242, United States
  • Site US10048
    Pittsburgh, Pennsylvania 15213, United States
  • Site US10029
    Knoxville, Tennessee 37909, United States
  • Site US10042
    Nashville, Tennessee 37203, United States
  • Site US10077
    Nashville, Tennessee 37232, United States
  • Site US10076
    Fort Worth, Texas 76104, United States
  • Site US10082
    Houston, Texas 77030, United States
  • Site BE32003
    Edegem, Antwerp 2650, Belgium
  • Site BE32013
    Brasschaat, 2930, Belgium
  • Site BE32016
    Bruxelles, 1200, Belgium
  • Site BE32001
    Charleroi, 6000, Belgium
  • Site BE32009
    Leuven, 3000, Belgium
  • Site BE32007
    Liege, 4000, Belgium
  • Site CA15022
    Ottawa, Ontario K1H 8L6, Canada
  • Site CA15023
    Toronto, Ontario M4N 3M5, Canada
  • Site CA15028
    Regina, Saskatchewan S4T7T1, Canada
  • Site CA15026
    Saskatoon, Saskatchewan S7N 4H4, Canada
  • Site CA15001
    Quebec, G1S 4L8, Canada
  • Site IT39005
    Meldola, Forli 47014, Italy
  • Site IT39008
    Lecce, 73100, Italy
  • Site IT39002
    Milano, 20141, Italy
  • Site IT39003
    Milan, 20132, Italy
  • Site IT39001
    Sondrio, 23100, Italy
  • Site IT39021
    Udine, 33100, Italy
  • Site ES34014
    Pozuelo de Alarcon, Madrid 28223, Spain
  • Site ES34010
    Barcelona, 08035, Spain
  • Site ES34013
    Madrid, 28050, Spain
  • Site GB44003
    Edinburgh, EH4 2XU, United Kingdom
  • Site GB44013
    Manchester, M20 4BX, United Kingdom
  • Site GB44001
    Nottingham, NG5 1PB, United Kingdom
09

References and documents

Publications

  • Wardley A, Cortes J, Provencher L, Miller K, Chien AJ, Rugo HS, Steinberg J, Sugg J, Tudor IC, Huizing M, Young R, Abramson V, Bose R, Hart L, Chan S, Cameron D, Wright GS, Graas MP, Neven P, Rocca A, Russo S, Krop IE. The efficacy and safety of enzalutamide with trastuzumab in patients with HER2+ and androgen receptor-positive metastatic or locally advanced breast cancer. Breast Cancer Res Treat. 2021 May;187(1):155-165. doi: 10.1007/s10549-021-06109-7. Epub 2021 Feb 16. PubMed 33591468 ↗

Study documents

  • Study protocol · Jan 10, 2023
  • Statistical analysis plan · Mar 23, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Supporting information: Study protocol, Sap, Csr

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02091960
Lead sponsor
Astellas Pharma Global Development, Inc.
Collaborators
Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
Responsible party
Sponsor
First posted
Mar 19, 2014
Start date
Sep 5, 2014
Primary completion
Feb 28, 2017
Completion
Jan 30, 2024
Results posted
May 16, 2018
Last update
Apr 4, 2025

Study contacts

Executive Medical Director
study director · Astellas Pharma Global Development, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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