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
NCT02091960
ABOUT THIS STUDY
FOR MORE INFORMATION
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1-800-718-1021
- 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
- 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.
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Descriptive Information | |||||||||||||||||
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Brief Title ICMJE | 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 | ||||||||||||||||
Official Title ICMJE | A Phase 2, Multicenter, Open-label Study to Assess the Efficacy and Safety of Enzalutamide With Trastuzumab in Subjects With HER2+ AR+ Metastatic or Locally Advanced Breast Cancer | ||||||||||||||||
Brief Summary | The purpose of this study is to evaluate the efficacy of enzalutamide with trastuzumab in patients with HER2+ AR+ metastatic or locally advanced breast cancer. | ||||||||||||||||
Detailed Description | Not Provided | ||||||||||||||||
Study Type ICMJE | Interventional | ||||||||||||||||
Study Phase ICMJE | Phase 2 | ||||||||||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||||||||||||||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE | 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. Interventions:
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Publications * | Not Provided | ||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||||||||||||
Recruitment Information | |||||||||||||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||||||||||||
Actual Enrollment ICMJE | 103 | ||||||||||||||||
Original Estimated Enrollment ICMJE | 80 | ||||||||||||||||
Estimated Study Completion Date ICMJE | March 2023 | ||||||||||||||||
Actual Primary Completion Date | February 28, 2017 (Final data collection date for primary outcome measure) | ||||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||
Listed Location Countries ICMJE | Belgium, Canada, Italy, Spain, United Kingdom, United States | ||||||||||||||||
Removed Location Countries | |||||||||||||||||
Administrative Information | |||||||||||||||||
NCT Number ICMJE | NCT02091960 | ||||||||||||||||
Other Study ID Numbers ICMJE | 9785-CL-1121 2013-000093-29 ( EudraCT Number ) | ||||||||||||||||
Has Data Monitoring Committee | No | ||||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. ) | ||||||||||||||||
Study Sponsor ICMJE | Astellas Pharma Global Development, Inc. | ||||||||||||||||
Collaborators ICMJE | Medivation LLC, a wholly owned subsidiary of Pfizer Inc. | ||||||||||||||||
Investigators ICMJE |
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PRS Account | Astellas Pharma Inc | ||||||||||||||||
Verification Date | December 2020 | ||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |