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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01004081
• Other study ID #: 120BC201
• Status: Completed
• Phase: Phase 2
• First received: September 18, 2009
• Last updated: September 17, 2015
• Start date: November 2009
• Est. completion date: October 2011

Study information

• Verified date: December 2011
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• BIIB021
BID orally for 28 days
• BIIB021
TIW orally for 28 days
• exemestane (Aromasin)
Daily in tablet form for 28 days

Locations

Country	Name	City	State
Australia	Research Site	Geelong	Victoria
Australia	Research Site	Herston	Queensland
Australia	Research Site	Hobart	Tasmania
Australia	Research Site	Redcliffe	Queensland
Australia	Research Site	Waratah	New South Wales
Australia	Research Site	Wollongong	New South Wales
Belgium	Research Site	Brasschaat
Belgium	Research Site	Edegem
Belgium	Research Site	Kortrijk
Belgium	Research Site	Liege
Belgium	Research Site	Mons
Russian Federation	Research Site	Kuzmolovskiy
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Ryazan
Russian Federation	Research Site	St. Petersburg
United States	Research Site	Alabaster	Alabama
United States	Research Site	Berkeley Heights	New Jersey
United States	Research Site	Columbus	Ohio
United States	Research Site	Davie	Florida
United States	Research Site	El Paso	Texas
United States	Research Site	Encinitas	California
United States	Research Site	Encinitas	California
United States	Research Site	Fargo	North Dakota
United States	Research Site	Gilroy	California
United States	Research Site	Houston	Texas
United States	Research Site	Lacey	Washington
United States	Research Site	Long Beach	California
United States	Research Site	Nashville	Tennessee
United States	Research Site	New York	New York
United States	Research Site	Orlando	Florida
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research Site	Rochester	Minnesota
United States	Research Site	San Antonio	Texas
United States	Research Site	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes