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Safety and Efficacy Study of Enzalutamide in Patients With Advanced, Androgen Receptor-Positive, Triple Negative Breast Cancer

Last updated on February 28, 2019

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Study Location
Rocky Mountain Cancer Centers
Colorado Springs, Colorado, 80907 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Androgen Receptor Positive Triple Negative Breast Cancer Advanced
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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 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.

NCT01889238
Pfizer
Active, not recruiting
Safety and Efficacy Study of Enzalutamide in Patients With Advanced, Androgen Receptor-Positive, Triple Negative Breast Cancer

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Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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