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

This study has been completed.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01004081
First received: September 18, 2009
Last updated: June 7, 2012
Last verified: December 2011
History of Changes
  Purpose

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 Intervention Phase
Breast Cancer
 Drug: BIIB021
Drug: exemestane (Aromasin)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Drug Information available for: Exemestane
U.S. FDA Resources

Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 54
Study Start Date: November 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01004081

  Show 35 Study Locations
Sponsors and Collaborators
Biogen Idec
  More Information

No publications provided

Responsible Party: Julie Morrissey, Quintiles
ClinicalTrials.gov Identifier: NCT01004081     History of Changes
Other Study ID Numbers: 120BC201
Study First Received: September 18, 2009
Last Updated: June 7, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Biogen Idec:
Cancer of Breast
Cancer of the Breast

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Exemestane
 Aromatase Inhibitors
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013