Hormone Receptor Positive Metastatic Breast Cancer (HR+ mBC) BIIB021 Plus Aromasin Schedule Finding
NCT ID: NCT01004081
Last Updated: 2015-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
54 participants
INTERVENTIONAL
2009-11-30
2011-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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BIIB021 BID + exemestane
BIIB021 100 mg BID + exemestane 25 mg QD
BIIB021
BID orally for 28 days
exemestane (Aromasin)
Daily in tablet form for 28 days
BIIB021 TIW + exemestane
BIIB021 450 mg TIW + exemestane 25 mg QD
BIIB021
TIW orally for 28 days
exemestane (Aromasin)
Daily in tablet form for 28 days
Interventions
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BIIB021
BID orally for 28 days
BIIB021
TIW orally for 28 days
exemestane (Aromasin)
Daily in tablet form for 28 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must have histologically or cytologically confirmed estrogen receptor- positive or progesterone receptor-positive, incurable, locally advanced, or metastatic breast cancer.
* Must have disease progression during treatment with a nonsteroidal AI for locally advanced or metastatic disease, or relapse during treatment or within 12 months of discontinuation of treatment in the adjuvant setting.
* Must be a postmenopausal female.
* Must have measurable or evaluable disease.
* Measurable disease is defined as \>=1 lesion with a diameter of \>=10 mm
* Evaluable disease is defined as bone lesions evaluable by plain X ray, CT scan, or MRI. Lesions identified only by radionuclide bone scan are not allowed.
* One prior chemotherapy regimen for advanced mBC is allowed.
* Prior radiotherapy is allowed.
* Must be able to swallow and retain oral medication.
* ECOG performance status of \<=2
* Required laboratory values
* Plasma cortisol and adrenocorticotropic hormone (ACTH) levels that are not suggestive of adrenal insufficiency unless on replacement therapy for known adrenal insufficiency.
Exclusion Criteria
* History of central nervous system (CNS) metastasis.
* Previous treatment with exemestane or treatment with an Hsp90 inhibitor.
* Use of proton pump inhibitors.
* Known history of or positive test result for hepatitis B or C or HIV.
* History of gastrectomy or major surgery to small intestine.
18 Years
FEMALE
No
Sponsors
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Biogen
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
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Research Site
Alabaster, Alabama, United States
Research Site
Encinitas, California, United States
Research Site
Encinitas, California, United States
Research Site
Gilroy, California, United States
Research Site
Long Beach, California, United States
Research Site
Davie, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
Rochester, Minnesota, United States
Research Site
St Louis, Missouri, United States
Research Site
Berkeley Heights, New Jersey, United States
Research Site
New York, New York, United States
Research Site
Fargo, North Dakota, United States
Research Site
Columbus, Ohio, United States
Research Site
Pittsburgh, Pennsylvania, United States
Research Site
Nashville, Tennessee, United States
Research Site
El Paso, Texas, United States
Research Site
Houston, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Lacey, Washington, United States
Research Site
Waratah, New South Wales, Australia
Research Site
Wollongong, New South Wales, Australia
Research Site
Herston, Queensland, Australia
Research Site
Redcliffe, Queensland, Australia
Research Site
Hobart, Tasmania, Australia
Research Site
Geelong, Victoria, Australia
Research Site
Brasschaat, , Belgium
Research Site
Edegem, , Belgium
Research Site
Kortrijk, , Belgium
Research Site
Liège, , Belgium
Research Site
Mons, , Belgium
Research Site
Kuzmolovskiy, , Russia
Research Site
Moscow, , Russia
Research Site
Ryazan, , Russia
Research Site
Saint Petersburg, , Russia
Countries
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Other Identifiers
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120BC201
Identifier Type: -
Identifier Source: org_study_id
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