Breast Cancer Clinical Trial

Biogen Idec 120BC201

INDICATION:
Hormone-receptor positive (HR+) advanced breast cancer

TITLE:
Phase 2a, Open-Label, Randomized Noncomparative Study of BIIB021 in Combination With Exemestane in Women With Hormone Receptor- positive (HR+), Advanced Metastatic Breast Cancer Who Have Progressed on a Nonsteroidal Aromatase Inhibitor 

IRB NAME:
Aspire IRB

STATUS:
Open for enrollment 

PHASE:
2a

PURPOSE:
To assess the efficacy and safety of 2 dosing regimens of BIIB021 in combination with exemestane in women whose HR+ breast cancer has progressed following treatment with a nonsteroidal aromatase inhibitor. 

ELIGIBILITY:
Candidates must:

• Be aged 18 years or older
• Have histologically or cytologically confirmed estrogen receptor-positive or progesterone receptor-positive, incurable, locally advanced, or metastatic breast cancer
• Have disease progression during treatment with a nonsteroidal aromatase inhibitor for locally advanced or metastatic disease, or relapse during treatment or within 12 months of discontinuation of treatment in the adjuvant setting

DURATION:
2 visits on cycle one; 1 visit on cycle two; then one visit every third cycle until disease progression for up to 5 years.

CONTACT/ADDITIONAL INFO:
Isabella Rodrigues, PhD
Clinical Research Coordinator
908-277-8630