Efficacy and Safety Study of Enzalutamide in Combination With Paclitaxel Chemotherapy or as Monotherapy Versus Placebo With Paclitaxel in Patients With Advanced, Diagnostic-Positive, Triple-Negative Breast Cancer
NCT02929576
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Adult women and men at least 18 years of age and willing and able to provide informed consent.
- Has advanced TNBC:
- TNBC is defined as staining by immunohistochemistry (IHC) < 1% or Allred score < 2 for estrogen receptor (ER) and progesterone receptor (PgR), and 0 or 1+ by IHC for human epidermal growth factor receptor 2 (HER2) or negative for gene amplification (average HER2 copy number < 4 signals/cell; HER2:CEP17 ratio < 2.0).
- Advanced disease is defined as locally advanced or metastatic disease not amenable to curative intent surgery or radiotherapy.
- Has diagnostic-positive status as determined by a central diagnostic testing laboratory.
- Received 0 or 1 prior line of systemic therapy in the advanced disease setting.
- Patients who received 1 prior line of therapy for locally advanced or metastatic TNBC must have objective disease progression as assessed by the investigator.
- Has measurable and/or disease that is not measurable but is evaluable using RECIST 1.1 (eg, bone metastases, pathologic lymph nodes, or skin lesions).
- Patients with nonmeasurable and nonevaluable TNBC (eg, malignant effusions or bone marrow as the only manifestations of disease) are not eligible for enrollment.
- Patients with metastatic disease limited to the bone must have disease adequately visualized by computed tomography (CT) with bone windows, magnetic resonance imaging (MRI), or x-ray.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 at screening and a life expectancy of at least 3 months from randomization.
- Received a taxane regimen ≥ 28 days in duration in the advanced disease setting.
- Prior taxane therapy for neoadjuvant and/or adjuvant disease is permitted.
- A single dose of a taxane given as part of an every-3-weeks regimen is permitted.
- Two doses of a taxane given as part of a once-weekly regimen is permitted.
- Had a disease-free interval of ≤ 12 months from the last dose of taxane when used as
part of adjuvant therapy for patients who did not receive prior therapy for locally
advanced or metastatic breast cancer.
- Has history of or known central nervous system (CNS) metastasis or active
leptomeningeal disease; brain imaging is required for all patients during screening.
- Received any anticancer agent (commercially available or investigational) within 14
days before randomization.
- Received treatment with any of the following medications within 14 days before
randomization:
- Estrogens, including hormone replacement therapy
- Androgens (eg, testosterone, dehydroepiandrosterone)
- Systemic radionuclides (eg, samarium, strontium)
- Had major surgery within 4 weeks before randomization.
- Has a history of another invasive cancer within 3 years before randomization, with the
exception of fully treated cancers with a remote probability of recurrence.
- Has a history of a seizure condition or any condition that may predispose to seizure
(eg, prior cortical stroke or significant brain trauma).
- Has known hypersensitivity to any of the enzalutamide/placebo capsule components.
- Had a hypersensitivity reaction to Cremophor EL (polyoxyethylated castor oil) or a
drug formulated in Cremophor EL, such as paclitaxel, unless successfully treated and
rechallenged with appropriate premedications.
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Descriptive Information | ||||
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Brief Title ICMJE | Efficacy and Safety Study of Enzalutamide in Combination With Paclitaxel Chemotherapy or as Monotherapy Versus Placebo With Paclitaxel in Patients With Advanced, Diagnostic-Positive, Triple-Negative Breast Cancer | |||
Official Title ICMJE | A Phase 3, Randomized, International Study Comparing the Efficacy and Safety of Enzalutamide in Combination With Paclitaxel Chemotherapy or as Monotherapy Versus Placebo With Paclitaxel in Patients With Advanced, Diagnostic-Positive, Triple-Negative Breast Cancer | |||
Brief Summary | The purpose of this study is to evaluate and compare the clinical benefit and safety of treatment with enzalutamide in combination with paclitaxel chemotherapy or as monotherapy versus placebo with paclitaxel in patients with locally advanced or metastatic, diagnostic-positive, triple-negative breast cancer (TNBC). | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment | |||
Condition ICMJE | Breast Cancer | |||
Intervention ICMJE |
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Study Arms ICMJE |
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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 | Withdrawn | |||
Actual Enrollment ICMJE | 0 | |||
Original Estimated Enrollment ICMJE | 780 | |||
Study Completion Date ICMJE | Not Provided | |||
Estimated Primary Completion Date | April 2019 (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 | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02929576 | |||
Other Study ID Numbers ICMJE | MDV3100-20 2016-000796-25 ( EudraCT Number ) | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | October 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |