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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

Last updated on March 15, 2019

FOR MORE INFORMATION
Study Location
Topeka, Kansas, 66606 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Cancer
Sex
Females and Males
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.
Show details

- 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) 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

- 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.

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

- 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.

NCT02929576
Pfizer
Withdrawn
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

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Pfizer Clinical Trials Contact Center

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[email protected]

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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