Breast Cancer
Conditions
Keywords
Cancer of Breast, Cancer of the Breast
Brief 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).
Interventions
DRUGBIIB021
BID orally for 28 days
Daily in tablet form for 28 days
Sponsors
Biogen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to assess the efficacy of 2 dosing regimens of BIIB021 in combination with exemestane in women whose HR+ breast cancer had progressed following treatment with a nonsteroidal AI. | As specified in protocol |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective of this study is to evaluate the safety and tolerability of BIIB021 in combination with exemestane in this study population. | As specified in protocol |
Countries
Australia, Belgium, Russia, United States
Outcome results
None listed