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Efficacy and Safety Study of Enzalutamide in Combination With Exemestane in Patients With Advanced Breast Cancer

Last updated on March 25, 2018

FOR MORE INFORMATION
Study Location
ATTN-Research Pharmacist
Aurora, Colorado, 80045 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Cancer
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.
Show details

- Willing and able to provide informed consent;

- Postmenopausal;

- Advanced histologically confirmed breast cancer that is ER+, PgR+, or both, and HER-2
normal;

- Up to one prior hormone therapy and up to one prior chemotherapy in the advanced
setting is allowed;

- Availability of a representative, formalin-fixed, paraffin-embedded tumor specimen
that enabled the diagnosis of breast cancer with viable tumor cells in a tissue block
or unstained serial slides accompanied bay an associated pathology report;

- Measurable disease. Patients with non-measurable bone or skin disease as their only
manifestation of advanced breast cancer are also eligible;

- Eastern Cooperative Oncology Group (ECOG) status of 0 or 1;

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

- Any severe concurrent disease, infection, or comorbid condition that renders the
patient inappropriate for enrollment in the opinion of the investigator;

- 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, in the opinion of the investigator;

- Current or previously treated brain metastasis or leptomeningeal disease;

- Prior therapy (> 28 days) with exemestane in the metastatic setting (Patients
receiving exemestane in the adjuvant setting and having disease recurrence more than 1
year after treatment discontinuation are eligible);

- Requires treatment for tuberculosis or HIV infection;

- Radiation therapy within 7 days before randomization;

- History of another invasive cancer within 5 years before randomization;

- History of seizure or any condition that may predispose to seizure;

- Clinically significant cardiovascular disease;

- Active gastrointestinal disorder;

- Major surgery within 28 days prior to randomization;

- Treatment with any oral anticancer or with any non-hormonal anticancer agent within 14
days before randomization;

- Treatment with any approved or investigational agent that blocks androgen synthesis or
targets the androgen receptor;

- Treatments with any of the following medications within 14 days before randomization:
Estrogens, Androgens, or Systemic radionuclides;

- Hypersensitivity reaction to exemestane.

NCT02007512
Pfizer
Active, not recruiting
Efficacy and Safety Study of Enzalutamide in Combination With Exemestane in Patients With Advanced Breast Cancer

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[email protected]

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Efficacy and Safety Study of Enzalutamide in Combination With Exemestane in Patients With Advanced Breast Cancer
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Efficacy and Safety of Enzalutamide in Combination With Exemestane in Patients With Advanced Breast Cancer That Is Estrogen or Progesterone Receptor-Positive and HER2-Normal
The purpose of this study is to determine if enzalutamide given in combination with exemestane is safe and effective in patients with advanced breast cancer.
This is a Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Efficacy and Safety of Enzalutamide in Combination With Exemestane in Patients With Advanced Breast Cancer That Is Estrogen or Progesterone Receptor Positive and HER2-Normal.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Breast Cancer
  • Drug: Enzalutamide
    160 mg/day administered as four 40-mg soft gelatin capsules by mouth once daily with or without food.
    Other Names:
    • MDV3100
    • XTANDI
  • Drug: exemestane
    25 mg capsule administered as a single capsule by mouth once daily after food.
  • Drug: Placebo (for enzalutamide)
    Sugar pill manufactured to mimic enzalutamide administered as four soft gelatin capsules by mouth once daily with or without food.
  • Drug: exemestane
    50 mg capsule administered as a single capsule by mouth once daily after food.
  • Experimental: Enzalutamide & exemestane
    Enzalutamide 160 mg/day administered as four 40-mg soft gelatin capsules by mouth once daily with or without food and exemestane 50mg capsule once daily after food.
    Interventions:
    • Drug: Enzalutamide
    • Drug: exemestane
  • Active Comparator: placebo & exemestane
    placebo and exemestane 25 mg once daily after food.
    Interventions:
    • Drug: exemestane
    • Drug: Placebo (for enzalutamide)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
247
June 29, 2018
September 23, 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Willing and able to provide informed consent;
  • Postmenopausal;
  • Advanced histologically confirmed breast cancer that is ER+, PgR+, or both, and HER-2 normal;
  • Up to one prior hormone therapy and up to one prior chemotherapy in the advanced setting is allowed;
  • Availability of a representative, formalin-fixed, paraffin-embedded tumor specimen that enabled the diagnosis of breast cancer with viable tumor cells in a tissue block or unstained serial slides accompanied bay an associated pathology report;
  • Measurable disease. Patients with non-measurable bone or skin disease as their only manifestation of advanced breast cancer are also eligible;
  • Eastern Cooperative Oncology Group (ECOG) status of 0 or 1;

Exclusion Criteria:

  • Any severe concurrent disease, infection, or comorbid condition that renders the patient inappropriate for enrollment in the opinion of the investigator;
  • 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, in the opinion of the investigator;
  • Current or previously treated brain metastasis or leptomeningeal disease;
  • Prior therapy (> 28 days) with exemestane in the metastatic setting (Patients receiving exemestane in the adjuvant setting and having disease recurrence more than 1 year after treatment discontinuation are eligible);
  • Requires treatment for tuberculosis or HIV infection;
  • Radiation therapy within 7 days before randomization;
  • History of another invasive cancer within 5 years before randomization;
  • History of seizure or any condition that may predispose to seizure;
  • Clinically significant cardiovascular disease;
  • Active gastrointestinal disorder;
  • Major surgery within 28 days prior to randomization;
  • Treatment with any oral anticancer or with any non-hormonal anticancer agent within 14 days before randomization;
  • Treatment with any approved or investigational agent that blocks androgen synthesis or targets the androgen receptor;
  • Treatments with any of the following medications within 14 days before randomization: Estrogens, Androgens, or Systemic radionuclides;
  • Hypersensitivity reaction to exemestane.
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Canada,   Ireland,   Italy,   Spain,   United Kingdom,   United States
 
 
NCT02007512
MDV3100-12
2013-002717-35 ( EudraCT Number )
C3431008 ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
  • Astellas Pharma Inc
  • Medivation, Inc.
Study Director: Pfizer CT.gov Call Center Pfizer
Study Director: Medical Director Medivation, Inc.
Pfizer
July 2017

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.

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1-800-718-1021

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Contact

[email protected]



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