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

September 17, 2015 updated by: Biogen

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Waratah, New South Wales, Australia
        • Research Site
      • Wollongong, New South Wales, Australia
        • Research Site
    • Queensland
      • Herston, Queensland, Australia
        • Research Site
      • Redcliffe, Queensland, Australia
        • Research Site
    • Tasmania
      • Hobart, Tasmania, Australia
        • Research Site
    • Victoria
      • Geelong, Victoria, Australia
        • Research Site
  • Belgium
      • Brasschaat, Belgium
        • Research Site
      • Edegem, Belgium
        • Research Site
      • Kortrijk, Belgium
        • Research Site
      • Liege, Belgium
        • Research Site
      • Mons, Belgium
        • Research Site
  • Russian Federation
      • Kuzmolovskiy, Russian Federation
        • Research Site
      • Moscow, Russian Federation
        • Research Site
      • Ryazan, Russian Federation
        • Research Site
      • St. Petersburg, Russian Federation
        • Research Site
  • United States
    • Alabama
      • Alabaster, Alabama, United States
        • Research Site
    • California
      • Encinitas, California, United States, 92024
        • Research Site
      • Encinitas, California, United States
        • Research Site
      • Gilroy, California, United States
        • Research Site
      • Long Beach, California, United States
        • Research Site
    • Florida
      • Davie, Florida, United States
        • Research Site
      • Orlando, Florida, United States
        • Research Site
    • Minnesota
      • Rochester, Minnesota, United States
        • Research Site
    • Missouri
      • St. Louis, Missouri, United States
        • Research Site
    • New Jersey
      • Berkeley Heights, New Jersey, United States
        • Research Site
    • New York
      • New York, New York, United States
        • Research Site
    • North Dakota
      • Fargo, North Dakota, United States
        • Research Site
    • Ohio
      • Columbus, Ohio, United States
        • Research Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States
        • Research Site
    • Tennessee
      • Nashville, Tennessee, United States
        • Research Site
    • Texas
      • El Paso, Texas, United States
        • Research Site
      • Houston, Texas, United States
        • Research Site
      • San Antonio, Texas, United States, 78229
        • Research Site
    • Washington
      • Lacey, Washington, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BIIB021 BID + exemestane
BIIB021 100 mg BID + exemestane 25 mg QD
Drug: BIIB021
BID orally for 28 days
Other Names:
  • CNF2024
Drug: BIIB021
TIW orally for 28 days
Other Names:
  • CNF2024
Drug: exemestane (Aromasin)
Daily in tablet form for 28 days
Other Names:
  • Aromasin
Experimental: BIIB021 TIW + exemestane
BIIB021 450 mg TIW + exemestane 25 mg QD
Drug: BIIB021
BID orally for 28 days
Other Names:
  • CNF2024
Drug: BIIB021
TIW orally for 28 days
Other Names:
  • CNF2024
Drug: exemestane (Aromasin)
Daily in tablet form for 28 days
Other Names:
  • Aromasin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
As specified in protocol

Secondary Outcome Measures

Outcome Measure
Time Frame
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
As specified in protocol

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

September 18, 2009

First Submitted That Met QC Criteria

October 28, 2009

First Posted (Estimate)

October 29, 2009

Study Record Updates

Last Update Posted (Estimate)

October 2, 2015

Last Update Submitted That Met QC Criteria

September 17, 2015

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 120BC201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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