Trials / Completed
CompletedNCT01004081
Hormone Receptor Positive Metastatic Breast Cancer (HR+ mBC) BIIB021 Plus Aromasin Schedule Finding
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 54 (actual)
- Sponsor
- Biogen · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BIIB021 | BID orally for 28 days |
| DRUG | BIIB021 | TIW orally for 28 days |
| DRUG | exemestane (Aromasin) | Daily in tablet form for 28 days |
Timeline
- Start date
- 2009-11-01
- Primary completion
- 2011-10-01
- Completion
- 2011-10-01
- First posted
- 2009-10-29
- Last updated
- 2015-10-02
Locations
34 sites across 4 countries: United States, Australia, Belgium, Russia
Source: ClinicalTrials.gov record NCT01004081. Inclusion in this directory is not an endorsement.