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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 December 5, 2018

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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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
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
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).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Breast Cancer
  • Drug: Enzalutamide
    Enzalutamide will be administered as four 40-mg capsules once daily (160 mg/day).
    Other Names:
    • Xtandi
    • MDV3100
  • Drug: Placebo
  • Drug: Paclitaxel
    Paclitaxel (90 mg/m2) will be administered by constant-rate intravenous infusion of ? 1 hour once weekly for 16 weeks. Dose reductions or alterations to the schedule are allowed to maintain patient safety.
  • Experimental: Double-blind enzalutamide with paclitaxel
    Interventions:
    • Drug: Enzalutamide
    • Drug: Paclitaxel
  • Placebo Comparator: Double-blind placebo with paclitaxel
    Interventions:
    • Drug: Placebo
    • Drug: Paclitaxel
  • Experimental: Open-label enzalutamide monotherapy followed by paclitaxel
    At the time of disease progression, enzalutamide treatment will be discontinued and paclitaxel will be administered if considered to be an appropriate treatment by the treating physician until second disease progression.
    Interventions:
    • Drug: Enzalutamide
    • Drug: Paclitaxel
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
780
Not Provided
April 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02929576
MDV3100-20
2016-000796-25 ( EudraCT Number )
Yes
Not Provided
Plan to Share IPD: No
Pfizer
Pfizer
  • Astellas Pharma Inc
  • Medivation, Inc.
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2018

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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