At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed locally advanced or metastatic breast cancer
- ✓ER and/or PR positive (>10 fmol/mg by biochemical assay or ≥10% by IHC)
- ✓Resistant to aromatase inhibitor therapy
- ✓Postmenopausal status
- ✕Prior fulvestrant or enzastaurin treatment
- ✕HER2-positive disease
- ✕Documented CNS metastases
- ✕Hepatic involvement >1/3 of liver
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Phase II Trial of Fulvestrant Plus Enzastaurin Versus Fulvestrant Plus Placebo in Aromatase Inhibitor-Resistant Metastatic Breast Cancer
In Brief
A Phase 2 clinical trial evaluating enzastaurin, placebo, and 1 other intervention for Breast Cancer. Completed, enrolled 156 participants across 21 sites in 5 countries.
Detailed Summary
The primary purpose of this study is to help answer the following research question: whether enzastaurin given together with fulvestrant can help participants who have breast cancer and make the tumor smaller or disappear and for how long.
Study Details
Timeline
Interventions
1125 milligram (mg) loading dose then 250 mg, oral, twice daily (for a total of 500 mg), until disease progression
oral, daily
500 mg, intramuscular (IM), day 1, 1250 mg, IM, day 15 cycle 1 then 250 mg, IM, every 28 days, until disease progression