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

Biogen1 site in 1 country54 target enrollmentNovember 2009

ConditionsBreast Cancer

InterventionsBIIB021 exemestane (Aromasin)

DrugsBIIB021 exemestane (Aromasin)

Overview

Phase: Phase 2
Intervention: BIIB021
Conditions: Breast Cancer
Sponsor: Biogen
Enrollment: 54
Locations: 1
Primary Endpoint: 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.
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

November 2009

End Date

October 2011

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Biogen

Responsible Party

Sponsor

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.

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.

Arms & Interventions

BIIB021 BID + exemestane

BIIB021 100 mg BID + exemestane 25 mg QD

Intervention: BIIB021

BIIB021 BID + exemestane

BIIB021 100 mg BID + exemestane 25 mg QD

Intervention: exemestane (Aromasin)

BIIB021 TIW + exemestane

BIIB021 450 mg TIW + exemestane 25 mg QD

Intervention: BIIB021

BIIB021 TIW + exemestane

BIIB021 450 mg TIW + exemestane 25 mg QD

Intervention: exemestane (Aromasin)

Outcomes

Primary Outcomes

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.

Time Frame: As specified in protocol

Secondary Outcomes

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)