Clinical trial · Interventional
Enzastaurin Plus Fulvestrant vs. Placebo Plus Fulvestrant in Breast Cancer
A Randomized, Double-Blind, Phase II Trial of Fulvestrant Plus Enzastaurin Versus Fulvestrant Plus Placebo in Aromatase Inhibitor-Resistant Metastatic Breast Cancer
NCT00451555CI-TRIAL-00041395completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| enzastaurin | Drug | Enzastaurin | ALIAS |
| fulvestrant | Drug | Fulvestrant | ALIAS |
| placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Enzastaurin + Fulvestrant
- description
- Participants received Enzastaurin loading dose of 1125 mg, on Day 1 of Cycle 1 only then received Enzastaurin 500 mg orally (QD) once daily in a 28-day cycle. Participants received enzastaurin loading dose of 1125 mg, on Day 1 of Cycle 1 only then received Enzastaurin 250 mg orally (BID) twice daily in a 28-day cycle. Fulvestrant was given intramuscularly at a loading dose of 500 mg on Day 1 and 250 mg on Day 15 in Cycle 1. Subsequent doses of Fulvestrant 250 mg were given on Day 1 of Cycle 2 and every 28 days thereafter.
- interventionNames
- Drug: enzastaurin
- Drug: fulvestrant
- type
- PLACEBO_COMPARATOR
- label
- Fulvestrant + Placebo
- description
- Participants received fulvestrant: 500 mg, IM, day 1, 1250 mg, IM, day 15 cycle 1 then 250 mg, IM, every 28 days, until disease progression. Then, participants received placebo, oral, daily.
- interventionNames
- Drug: placebo
- Drug: fulvestrant
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.