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

Last updated date
Study Location
Topeka, Kansas, 66606, United States
Contact
1-800-718-1021

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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) < 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
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.

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

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Advanced Information
Descriptive Information
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
  • 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.
Study Arms  ICMJE
  • 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
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
 (submitted: June 1, 2017)
0
Original Estimated Enrollment  ICMJE
 (submitted: October 7, 2016)
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:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Plan to Share IPD:No
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE
  • Astellas Pharma Inc
  • Medivation, Inc.
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
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