Hormone Receptor Positive Metastatic Breast Cancer (HR+ mBC) BIIB021 Plus Aromasin Schedule Finding
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
1 other identifier
interventional
54
4 countries
34
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 breast-cancer
Started Nov 2009
Shorter than P25 for phase_2 breast-cancer
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2009
CompletedFirst Posted
Study publicly available on registry
October 29, 2009
CompletedStudy Start
First participant enrolled
November 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedOctober 2, 2015
December 1, 2011
1.9 years
September 18, 2009
September 17, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Study Arms (2)
BIIB021 BID + exemestane
EXPERIMENTALBIIB021 100 mg BID + exemestane 25 mg QD
BIIB021 TIW + exemestane
EXPERIMENTALBIIB021 450 mg TIW + exemestane 25 mg QD
Interventions
Daily in tablet form for 28 days
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (34)
Research Site
Alabaster, Alabama, United States
Research Site
Encinitas, California, 92024, United States
Research Site
Encinitas, California, United States
Research Site
Gilroy, California, United States
Research Site
Long Beach, California, United States
Research Site
Davie, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
Rochester, Minnesota, United States
Research Site
St Louis, Missouri, United States
Research Site
Berkeley Heights, New Jersey, United States
Research Site
New York, New York, United States
Research Site
Fargo, North Dakota, United States
Research Site
Columbus, Ohio, United States
Research Site
Pittsburgh, Pennsylvania, United States
Research Site
Nashville, Tennessee, United States
Research Site
El Paso, Texas, United States
Research Site
Houston, Texas, United States
Research Site
San Antonio, Texas, 78229, United States
Research Site
Lacey, Washington, United States
Research Site
Waratah, New South Wales, Australia
Research Site
Wollongong, New South Wales, Australia
Research Site
Herston, Queensland, Australia
Research Site
Redcliffe, Queensland, Australia
Research Site
Hobart, Tasmania, Australia
Research Site
Geelong, Victoria, Australia
Research Site
Brasschaat, Belgium
Research Site
Edegem, Belgium
Research Site
Kortrijk, Belgium
Research Site
Liège, Belgium
Research Site
Mons, Belgium
Research Site
Kuzmolovskiy, Russia
Research Site
Moscow, Russia
Research Site
Ryazan, Russia
Research Site
Saint Petersburg, Russia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2009
First Posted
October 29, 2009
Study Start
November 1, 2009
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
October 2, 2015
Record last verified: 2011-12