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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01004081
First Posted: October 29, 2009
Last Update Posted: October 2, 2015
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.
Information provided by (Responsible Party):
Biogen
  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
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

Resource links provided by NLM:


Further study details as provided by Biogen:

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 ]

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 ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
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


  Show 34 Study Locations
Sponsors and Collaborators
Biogen
Investigators
Study Director: Medical Director Biogen
  More Information

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT01004081     History of Changes
Other Study ID Numbers: 120BC201
First Submitted: September 18, 2009
First Posted: October 29, 2009
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:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Hormones
Exemestane
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists