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

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Drug: BIIB021; Drug: exemestane (Aromasin)

• Registration Number: NCT01004081
• Lead Sponsor: Biogen

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-09-18
• Study First Submitted QC: 2009-10-28
• Study First Posted: 2009-10-29
• Study Start: 2009-11
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2011-12
• Disposition First Submitted: 2015-09-17
• Disposition First Submitted QC: 2015-09-17
• Last Update Submitted: 2015-09-17
• Disposition First Posted: 2015-10-02
• Last Update Posted: 2015-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 54

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BIIB021 BID + exemestane	exemestane (Aromasin)	BIIB021 100 mg BID + exemestane 25 mg QD
BIIB021 TIW + exemestane	exemestane (Aromasin)	BIIB021 450 mg TIW + exemestane 25 mg QD
BIIB021 TIW + exemestane	BIIB021	BIIB021 450 mg TIW + exemestane 25 mg QD
BIIB021 BID + exemestane	BIIB021	BIIB021 100 mg BID + exemestane 25 mg QD

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇷🇺 St. Petersburg, Russian Federation