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

Last updated on March 15, 2019

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.
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- 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.
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- 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

NEED INFO?

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

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

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FOR MORE INFORMATION

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]

Call Now