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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01004081
Recruitment Status : Completed
First Posted : October 29, 2009
Last Update Posted : October 2, 2015
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: BIIB021 Drug: exemestane (Aromasin) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2009
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Exemestane

Arm Intervention/treatment
Experimental: BIIB021 BID + exemestane
BIIB021 100 mg BID + exemestane 25 mg QD
Drug: BIIB021
BID orally for 28 days
Other Name: CNF2024

Drug: exemestane (Aromasin)
Daily in tablet form for 28 days
Other Name: Aromasin

Experimental: BIIB021 TIW + exemestane
BIIB021 450 mg TIW + exemestane 25 mg QD
Drug: BIIB021
TIW orally for 28 days
Other Name: CNF2024

Drug: exemestane (Aromasin)
Daily in tablet form for 28 days
Other Name: Aromasin




Primary Outcome Measures :
  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. [ Time Frame: As specified in protocol ]

Secondary Outcome Measures :
  1. The secondary objective of this study is to evaluate the safety and tolerability of BIIB021 in combination with exemestane in this study population. [ Time Frame: As specified in protocol ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01004081


Locations
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United States, Alabama
Research Site
Alabaster, Alabama, United States
United States, California
Research Site
Encinitas, California, United States, 92024
Research Site
Encinitas, California, United States
Research Site
Gilroy, California, United States
Research Site
Long Beach, California, United States
United States, Florida
Research Site
Davie, Florida, United States
Research Site
Orlando, Florida, United States
United States, Minnesota
Research Site
Rochester, Minnesota, United States
United States, Missouri
Research Site
St. Louis, Missouri, United States
United States, New Jersey
Research Site
Berkeley Heights, New Jersey, United States
United States, New York
Research Site
New York, New York, United States
United States, North Dakota
Research Site
Fargo, North Dakota, United States
United States, Ohio
Research Site
Columbus, Ohio, United States
United States, Pennsylvania
Research Site
Pittsburgh, Pennsylvania, United States
United States, Tennessee
Research Site
Nashville, Tennessee, United States
United States, Texas
Research Site
El Paso, Texas, United States
Research Site
Houston, Texas, United States
Research Site
San Antonio, Texas, United States, 78229
United States, Washington
Research Site
Lacey, Washington, United States
Australia, New South Wales
Research Site
Waratah, New South Wales, Australia
Research Site
Wollongong, New South Wales, Australia
Australia, Queensland
Research Site
Herston, Queensland, Australia
Research Site
Redcliffe, Queensland, Australia
Australia, Tasmania
Research Site
Hobart, Tasmania, Australia
Australia, Victoria
Research Site
Geelong, Victoria, Australia
Belgium
Research Site
Brasschaat, Belgium
Research Site
Edegem, Belgium
Research Site
Kortrijk, Belgium
Research Site
Liege, Belgium
Research Site
Mons, Belgium
Russian Federation
Research Site
Kuzmolovskiy, Russian Federation
Research Site
Moscow, Russian Federation
Research Site
Ryazan, Russian Federation
Research Site
St. Petersburg, Russian Federation
Sponsors and Collaborators
Biogen
Investigators
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Study Director: Medical Director Biogen
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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT01004081    
Other Study ID Numbers: 120BC201
First Posted: October 29, 2009    Key Record Dates
Last Update Posted: October 2, 2015
Last Verified: December 2011
Keywords provided by Biogen:
Cancer of Breast
Cancer of the Breast
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Exemestane
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs