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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


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

As specified in protocol

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

120BC201

NCT ID:

NCT01004081

Start Date:

November 2009

Completion Date:

October 2011

Related Keywords:

  • Breast Cancer
  • Cancer of Breast
  • Cancer of the Breast
  • Breast Neoplasms

Name

Location

Research SiteAlabaster, Alabama  
Research SiteAnaheim, California  
Research SiteBoca Raton, Florida  
Research SiteBelleville, New Jersey  
Research SiteBismarck, North Dakota  
Research SiteAkron, Ohio  
Research SiteAllentown, Pennsylvania  
Research SiteAbilene, Texas  
Research SiteAuburn, Washington