Clinical trial NCT01004081: Hormone Receptor Positive Metastatic Breast Cancer (HR+ mBC) BIIB021 Plus Aromasin Schedule Finding
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Cancer of Breast
Cancer of the Breast
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2009-10-29
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.
* 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.

Primary outcomes:
measure: 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.
timeFrame: As specified in protocol
Secondary outcomes:
measure: The secondary objective of this study is to evaluate the safety and tolerability of BIIB021 in combination with exemestane in this study population.
timeFrame: As specified in protocol
Other outcomes:
Locations:
city: Alabaster
country: United States
facility: Research Site
state: Alabama
city: Encinitas
country: United States
facility: Research Site
state: California
city: Encinitas
country: United States
facility: Research Site
state: California
city: Gilroy
country: United States
facility: Research Site
state: California
city: Long Beach
country: United States
facility: Research Site
state: California
city: Davie
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
city: Rochester
country: United States
facility: Research Site
state: Minnesota
city: St. Louis
country: United States
facility: Research Site
state: Missouri
city: Berkeley Heights
country: United States
facility: Research Site
state: New Jersey
city: New York
country: United States
facility: Research Site
state: New York
city: Fargo
country: United States
facility: Research Site
state: North Dakota
city: Columbus
country: United States
facility: Research Site
state: Ohio
city: Pittsburgh
country: United States
facility: Research Site
state: Pennsylvania
city: Nashville
country: United States
facility: Research Site
state: Tennessee
city: El Paso
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Lacey
country: United States
facility: Research Site
state: Washington
city: Waratah
country: Australia
facility: Research Site
state: New South Wales
city: Wollongong
country: Australia
facility: Research Site
state: New South Wales
city: Herston
country: Australia
facility: Research Site
state: Queensland
city: Redcliffe
country: Australia
facility: Research Site
state: Queensland
city: Hobart
country: Australia
facility: Research Site
state: Tasmania
city: Geelong
country: Australia
facility: Research Site
state: Victoria
city: Brasschaat
country: Belgium
facility: Research Site
city: Edegem
country: Belgium
facility: Research Site
city: Kortrijk
country: Belgium
facility: Research Site
city: Liege
country: Belgium
facility: Research Site
city: Mons
country: Belgium
facility: Research Site
city: Kuzmolovskiy
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Ryazan
country: Russian Federation
facility: Research Site
city: St. Petersburg
country: Russian Federation
facility: Research Site
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: