Safety and Efficacy Study of Enzalutamide in Patients With Advanced, Androgen Receptor-Positive, Triple Negative Breast Cancer
NCT01889238
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
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1-800-718-1021
- Women at least 18 years of age;
- Advanced AR+ TNBC;
- Availability of a representative tumor specimen:
- Either measurable disease or bone only nonmeasurable disease;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Any severe concurrent disease, infection, or comorbid condition;
- Any condition or reason that interferes with the patient's ability to participate in
the trial, that may cause undue risk, or complicates the interpretation of safety
data;
- Current or previously treated brain metastasis or active leptomeningeal disease;
- Current hormone replacement therapy;
- Local palliative radiation therapy within 7 days before day 1;
- History of another invasive cancer within 5 years of day 1;
- Absolute neutrophil count < 1500/µL, platelet count < 75,000/µL, or hemoglobin < 9
g/dL (5.6 mmol/L) at the screening visit;
- Creatinine > 1.5 times upper limit of normal (ULN) at the screening visit;
- History of seizure or any condition that may predispose to seizure;
- Clinically significant cardiovascular disease;
- Active gastrointestinal disorder affecting absorption;
- Major surgery within 4 weeks before day 1;
- Treatment with any commercially available anticancer agent within 14 days before day
1;
- Treatment with any investigational agent within 2 weeks before day 1;
- Treatment with any of the following medications within 2 weeks before day 1:
Estrogens, including hormone replacement therapy; Androgens (testosterone,
dihydroepiandrosterone, etc);Systemic radionuclides (eg, samarium or
strontium);Vaccine therapy;
- Hypoglycemic episode requiring medical intervention while on insulin treatment within
12 months before day 1;
- Hypersensitivity reaction to the active pharmaceutical ingredient or any of the
capsule components, including Labrasol, butylated hydroxyanisole, and butylated
hydroxytoluene.
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Descriptive Information | |||||||
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Brief Title ICMJE | Safety and Efficacy Study of Enzalutamide in Patients With Advanced, Androgen Receptor-Positive, Triple Negative Breast Cancer | ||||||
Official Title ICMJE | A PHASE 2, SINGLE-ARM, OPEN-LABEL, MULTICENTER STUDY OF THE CLINICAL ACTIVITY AND SAFETY OF ENZALUTAMIDE IN PATIENTS WITH ADVANCED, ANDROGEN RECEPTOR-POSITIVE, TRIPLE-NEGATIVE BREAST CANCER | ||||||
Brief Summary | The purpose of this study is to determine if enzalutamide is safe and effective in the treatment of patients with advanced breast cancer that express the androgen receptor but do not express the estrogen or progesterone receptor and are not Her2 amplified. | ||||||
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 | Advanced, Androgen Receptor Positive Triple Negative Breast Cancer | ||||||
Intervention ICMJE | Drug: Enzalutamide
160 mg administered as four soft gelatin capsules orally once daily Other Names:
| ||||||
Study Arms ICMJE | Experimental: Enzalutamide
160 mg administered as four 40 mg soft gelatin capsules orally once daily Intervention: Drug: Enzalutamide | ||||||
Publications * | Traina TA, Miller K, Yardley DA, Eakle J, Schwartzberg LS, O'Shaughnessy J, Gradishar W, Schmid P, Winer E, Kelly C, Nanda R, Gucalp A, Awada A, Garcia-Estevez L, Trudeau ME, Steinberg J, Uppal H, Tudor IC, Peterson A, Cortes J. Enzalutamide for the Treatment of Androgen Receptor-Expressing Triple-Negative Breast Cancer. J Clin Oncol. 2018 Mar 20;36(9):884-890. doi: 10.1200/JCO.2016.71.3495. Epub 2018 Jan 26. | ||||||
* 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 | 118 | ||||||
Original Estimated Enrollment ICMJE | 80 | ||||||
Estimated Study Completion Date ICMJE | March 31, 2021 | ||||||
Actual Primary Completion Date | March 1, 2015 (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, Ireland, Italy, Spain, United Kingdom, United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT01889238 | ||||||
Other Study ID Numbers ICMJE | MDV3100-11 2013-000698-57 ( EudraCT Number ) C3431007 ( Other Identifier: Alias Study Number ) | ||||||
Has Data Monitoring Committee | Not Provided | ||||||
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 | April 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |