Enzastaurin Plus Fulvestrant vs. Placebo Plus Fulvestrant in Breast Cancer
NCT ID: NCT00451555
Last Updated: 2019-11-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
156 participants
INTERVENTIONAL
2007-04-11
2018-10-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Enzastaurin + Fulvestrant
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.
enzastaurin
1125 milligram (mg) loading dose then 250 mg, oral, twice daily (for a total of 500 mg), until disease progression
fulvestrant
500 mg, intramuscular (IM), day 1, 1250 mg, IM, day 15 cycle 1 then 250 mg, IM, every 28 days, until disease progression
Fulvestrant + Placebo
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.
placebo
oral, daily
fulvestrant
500 mg, intramuscular (IM), day 1, 1250 mg, IM, day 15 cycle 1 then 250 mg, IM, every 28 days, until disease progression
Interventions
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enzastaurin
1125 milligram (mg) loading dose then 250 mg, oral, twice daily (for a total of 500 mg), until disease progression
placebo
oral, daily
fulvestrant
500 mg, intramuscular (IM), day 1, 1250 mg, IM, day 15 cycle 1 then 250 mg, IM, every 28 days, until disease progression
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
* 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.
18 Years
FEMALE
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Besançon, , France
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Paris, , France
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Saint-Herblain, , France
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Toulouse, , France
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Bielefeld, , Germany
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Dresden, , Germany
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Gütersloh, , Germany
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Kiel, , Germany
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Mannheim, , Germany
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Meldola, , Italy
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Milan, , Italy
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Modena, , Italy
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Rome, , Italy
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Amsterdam, , Netherlands
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Groningen, , Netherlands
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Maastricht, , Netherlands
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The Hague, , Netherlands
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Barcelona, , Spain
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Lleida, , Spain
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Madrid, , Spain
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Valencia, , Spain
Countries
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Related Links
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Lilly Clinical Trial Registry
Other Identifiers
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H6Q-MC-S023
Identifier Type: OTHER
Identifier Source: secondary_id
10736
Identifier Type: -
Identifier Source: org_study_id
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