Breast Cancer Clinical Trial

Hormone Receptor Positive Metastatic Breast Cancer (HR+ mBC) BIIB021 Plus Aromasin Schedule Finding

Summary

The purpose of this study is to assess the efficacy, safety and tolerability of 2 dosing regimens of BIIB021 in combination with exemestane in women whose HR+ breast cancer had progressed following treatment with a nonsteroidal aromatase inhibitor (AI).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Age 18 years of age
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:

HER2 overexpressing tumor.
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.

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

54

Study ID:

NCT01004081

Recruitment Status:

Completed

Sponsor:

Biogen

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There are 2 Locations for this study

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Research Site
Alabaster Alabama, , United States
Research Site
Encinitas California, 92024, 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
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Rochester Minnesota, , United States
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St. Louis Missouri, , United States
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Berkeley Heights New Jersey, , United States
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New York New York, , United States
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Fargo North Dakota, , United States
Research Site
Columbus Ohio, , United States
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Pittsburgh Pennsylvania, , United States
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Nashville Tennessee, , United States
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El Paso Texas, , United States
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Houston Texas, , United States
Research Site
San Antonio Texas, 78229, United States
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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
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Brasschaat , , Belgium
Research Site
Edegem , , Belgium
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Kortrijk , , Belgium
Research Site
Liege , , Belgium
Research Site
Mons , , Belgium
Research Site
Kuzmolovskiy , , Russian Federation
Research Site
Moscow , , Russian Federation
Research Site
Ryazan , , Russian Federation
Research Site
St. Petersburg , , Russian Federation

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

54

Study ID:

NCT01004081

Recruitment Status:

Completed

Sponsor:


Biogen

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