Hormone Receptor Positive Metastatic Breast Cancer (HR+ mBC) BIIB021 Plus Aromasin Schedule Finding
Status: | Completed |
---|---|
Conditions: | Breast Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | November 2009 |
End Date: | October 2011 |
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).
regimens of BIIB021 in combination with exemestane in women whose HR+ breast cancer had
progressed following treatment with a nonsteroidal aromatase inhibitor (AI).
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.
We found this trial at
19
sites
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