Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments enzastaurin, placebo, fulvestrant
Phase phase 2
Sponsor Eli Lilly and Company
Start date March 2007
End date December 2010
Trial size 160 participants
Trial identifier NCT00451555, 10736, H6Q-MC-S023

Summary

The primary purpose of this study is to help answer the following research question: whether enzastaurin given together with fulvestrant can help patients who have breast cancer and make the tumor smaller or disappear and for how long.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
enzastaurin LY317615
1125 mg loading dose then 250 mg, oral, twice daily (for a total of 500 mg), until disease progression
fulvestrant
500 mg, IM, day 1, 1250 mg, IM, day 15 cycle 1 then 250 mg, IM, q 28 days, until disease progression
(Placebo Comparator)
placebo
oral, daily
fulvestrant
500 mg, IM, day 1, 1250 mg, IM, day 15 cycle 1 then 250 mg, IM, q 28 days, until disease progression

Primary Outcomes

Measure
Compare clinical benefit rate (CR+PR+SD for greater than or equal to 24 weeks)between fulvestrant plus enzastaurin and fulvestrant plus placebo in aromatase inhibitor resistant metastatic breast cancer
time frame: baseline to measured progressive disease

Secondary Outcomes

Measure
Response rates
time frame: baseline to measured progressive disease
Duration of clinical benefit
time frame: time of clinical benefit to progressive disease
Progression free survival
time frame: baseline to measured progressive disease
Safety and adverse event profile
time frame: every cycle
Assess biomarkers relevant to enzastaurin and the disease state as well as their correlation to clinical outcome
time frame: baseline, cycle 2, end of study

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Female patients with a histological-documented diagnosis of locally advanced or metastatic breast cancer. The primary or metastatic tumor must be ER and/or PtR receptor 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 - Patients are resistant to 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 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.

Additional Information

Official title A Randomized, Double-Blind, Phase II Trial of Fulvestrant Plus Enzastaurin Versus Fulvestrant Plus Placebo in Aromatase Inhibitor-Resistant Metastatic Breast Cancer
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.