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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: BIIB021
* Drug: BIIB021
* Drug: exemestane (Aromasin)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BIIB021 BID + exemestane<br>BIIB021 100 mg BID + exemestane 25 mg QD | Drug: BIIB021<br>* BID orally for 28 days<br>* Other names: CNF2024;Drug: exemestane (Aromasin)<br>* Daily in tablet form for 28 days<br>* Other names: Aromasin;|
| Experimental: BIIB021 TIW + exemestane<br>BIIB021 450 mg TIW + exemestane 25 mg QD | Drug: BIIB021<br>* TIW orally for 28 days<br>* Other names: CNF2024;Drug: exemestane (Aromasin)<br>* Daily in tablet form for 28 days<br>* Other names: Aromasin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer of Breast, Cancer of the Breast