drugset / Trial / NCT00828854
Study of the Effect of the Addition of SNDX-275 (Entinostat) to Continued Aromatase Inhibitor (AI) Therapy in Postmenopausal Women With ER+ Breast Cancer Whose Disease is Progressing
NaSingle-groupOpen-labelTreatment
Summary
The addition of entinostat to an AI will result in a maximal abrogation of estrogen receptor-α mediated activity and inhibit mechanisms of resistance to the aromatase inhibitor. It is hypothesized that entinostat with continued AI will increase the estimated AI clinical benefit rate (CBR) from 5% to 25% with an acceptable safety profile.
Timeline
- Start
- 2008-10-01
- Primary completion
- 2009-11-24
- Completion
- 2009-11-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Entinostat | Small molecule | 5 mg | Oral |
| Background | Anastrozole | Other / unclassified | 1 mg | Oral |
| Background | Exemestane | Small molecule | 25 mg | Oral |
| Background | Letrozole | Other / unclassified | 2.5 mg | Oral |