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).
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.
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There are 2 Locations for this study
Alabaster Alabama, , United States
Encinitas California, 92024, United States
Encinitas California, , United States
Gilroy California, , United States
Long Beach California, , United States
Davie Florida, , United States
Orlando Florida, , United States
Rochester Minnesota, , United States
St. Louis Missouri, , United States
Berkeley Heights New Jersey, , United States
New York New York, , United States
Fargo North Dakota, , United States
Columbus Ohio, , United States
Pittsburgh Pennsylvania, , United States
Nashville Tennessee, , United States
El Paso Texas, , United States
Houston Texas, , United States
San Antonio Texas, 78229, United States
Lacey Washington, , United States
Waratah New South Wales, , Australia
Wollongong New South Wales, , Australia
Herston Queensland, , Australia
Redcliffe Queensland, , Australia
Hobart Tasmania, , Australia
Geelong Victoria, , Australia
Brasschaat , , Belgium
Edegem , , Belgium
Kortrijk , , Belgium
Liege , , Belgium
Mons , , Belgium
Kuzmolovskiy , , Russian Federation
Moscow , , Russian Federation
Ryazan , , Russian Federation
St. Petersburg , , Russian Federation
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