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 ID: NCT02091960
Last Updated: 2025-04-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
103 participants
INTERVENTIONAL
2014-09-05
2024-01-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Enzalutamide
Capsules for oral administration
Trastuzumab
Intravenous infusion (IV) or subcutaneous injection if it is standard of care within a country
Interventions
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Enzalutamide
Capsules for oral administration
Trastuzumab
Intravenous infusion (IV) or subcutaneous injection if it is standard of care within a country
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
INDUSTRY
Astellas Pharma Global Development, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Executive Medical Director
Role: STUDY_DIRECTOR
Astellas Pharma Global Development, Inc.
Locations
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Site US10051
Anaheim, California, United States
Site US10028
Los Angeles, California, United States
Site US10035
San Francisco, California, United States
Site US10079
Fort Myers, Florida, United States
Site US10074
Gainesville, Florida, United States
Site US10081
Chicago, Illinois, United States
Site US10004
Indianapolis, Indiana, United States
Site US10070
Boston, Massachusetts, United States
Site US10078
St Louis, Missouri, United States
Site US10072
Cincinnati, Ohio, United States
Site US10048
Pittsburgh, Pennsylvania, United States
Site US10029
Knoxville, Tennessee, United States
Site US10042
Nashville, Tennessee, United States
Site US10077
Nashville, Tennessee, United States
Site US10076
Fort Worth, Texas, United States
Site US10082
Houston, Texas, United States
Site BE32003
Edegem, Antwerp, Belgium
Site BE32013
Brasschaat, , Belgium
Site BE32016
Brussels, , Belgium
Site BE32001
Charleroi, , Belgium
Site BE32009
Leuven, , Belgium
Site BE32007
Liège, , Belgium
Site CA15022
Ottawa, Ontario, Canada
Site CA15023
Toronto, Ontario, Canada
Site CA15028
Regina, Saskatchewan, Canada
Site CA15026
Saskatoon, Saskatchewan, Canada
Site CA15001
Québec, , Canada
Site IT39005
Meldola, Forli, Italy
Site IT39008
Lecce, , Italy
Site IT39003
Milan, , Italy
Site IT39002
Milan, , Italy
Site IT39001
Sondrio, , Italy
Site IT39021
Udine, , Italy
Site ES34014
Pozuelo de Alarcón, Madrid, Spain
Site ES34010
Barcelona, , Spain
Site ES34013
Madrid, , Spain
Site GB44003
Edinburgh, , United Kingdom
Site GB44013
Manchester, , United Kingdom
Site GB44001
Nottingham, , United Kingdom
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Link to plain language summary of the study on the Trial Results Summaries website
Other Identifiers
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2013-000093-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
9785-CL-1121
Identifier Type: -
Identifier Source: org_study_id
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