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



Status:Completed
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:November 2009
End Date:October 2011

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Phase 2a, Open-Label, Randomized, Noncomparative Study of BIIB021 in Combination With Exemestane in Women With Hormone Receptor-Positive, Advanced Metastatic Breast Cancer Who Have Progressed on a Nonsteroidal Aromatase Inhibitor

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).


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.
We found this trial at
19
sites
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Fargo, ND
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Alabaster, AL
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Berkeley Heights, New Jersey 07922
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Berkeley Heights, NJ
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from
Columbus, OH
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Davie, FL
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El Paso, TX
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Encinitas, CA
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Gilroy, CA
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Houston, TX
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Lacey, WA
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Long Beach, CA
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Nashville, TN
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New York, NY
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Orlando, FL
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Pittsburgh, PA
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Rochester, MN
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San Antonio, TX
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St. Louis, MO
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Waratah,
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