Phase 2
Completed N=156
Enzastaurin Plus Fulvestrant vs. Placebo Plus Fulvestrant in Breast Cancer
Source: ClinicalTrials.gov NCT00451555 ↗Enrolled (actual)
156
Serious AEs
18.3%
Results posted
Nov 2019
Primary outcomePrimary: Percentage of Participants Who Achieved a Best Response of Complete Response, Partial Response, and Stable Disease (CR+PR+SD) (Clinical Benefit Rate) — 43.6; 43.6; 43.6; 44.8 percentage of participants — p=0.6238
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved a Best Response of Complete Response, Partial Response, and Stable Disease (CR+PR+SD) (Clinical Benefit Rate) |
43.6; 43.6; 43.6; 44.8 | 0.6238 |
| SECONDARY Percentage of Participants Achieving Overall Tumor Response Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR]) |
5.3; 5.1; 5.5; 5.2 | 0.6390 |
| SECONDARY Duration of Clinical Benefit |
9.6; 9.4; 9.6; 9.7 | 0.8582 |
| SECONDARY Progression Free Survival (PFS) |
5.2; 3.7; 6.0; 5.5 | 0.5887 |
| SECONDARY Number of Participants Who Discontinued With Adverse Events (AE) and Serious Adverse Events (SAEs) |
3; 1; 2; 1; 0; 0 | — |
| SECONDARY Percentage of Participants With Enzastaurin Biomarkers and Disease State |
— | — |
Eligibility Criteria
Inclusion Criteria
- Female participants with a histological-documented diagnosis of locally advanced or metastatic breast cancer. The primary or metastatic tumor must be estrogen response (ER) and/or parathyroid hormone receptor (PtR) positive.
Note: Hormone receptor positivity is defined as ER or PtR greater than 10 fmol/mg by biochemical assay or 10% positive cells by immunohistochemistry
- Participants are resistant to aromatase inhibitors (AI) therapy
- Females with postmenopausal status
- Previous radiation therapy is allowed, but should have been limited
- Measurable or non-measurable disease
- Have a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) scale
- Have adequate organ function
- Have an estimated life expectancy of at least 24 weeks
- Must sign an informed consent document
Exclusion Criteria
- Have had prior treatment with fulvestrant or enzastaurin
- Are receiving concurrent administration of any other antitumor therapy, with the exception of gonadotropin-releasing hormone (GnRH) antagonists.
- Have received treatment within the last 4 weeks with a drug that has not received regulatory approval for any indication at the time of study entry
- Have received supplemental estrogen or progesterone within 4 weeks prior to study entry
- Are hormone estrogen receptor (HER2)-positive
- Are unable to discontinue use of anticoagulants
- Have hypercalcemia
- Have a second primary malignancy that is clinically detectable at the time of consideration for study enrollment
- Have documented central nervous system (CNS) metastases, symptomatic pulmonary lymphangitis, or involvement of more than 1/3 of the liver
- Have a serious concomitant systemic disorder
- Have a serious cardiac condition
- Are unwilling or unable to discontinue use of carbamazepine, phenobarbital, or phenytoin at least 14 days prior to study therapy
- Are unable to swallow tablets.
Data sourced from ClinicalTrials.gov (NCT00451555). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.