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

Completed · Phase 2

Conditions studied: Breast Cancer

In brief

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).

Key facts

Study ID

NCT01004081

Run by

Biogen

People needed

54

Starts

2009-11-01

Expected to finish

2011-10-01

Last updated by the study team

2015-10-02

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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