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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 18, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 29, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 2, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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