Status:
COMPLETED
Enzastaurin Plus Fulvestrant vs. Placebo Plus Fulvestrant in Breast Cancer
Lead Sponsor:
Eli Lilly and Company
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 11 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 18 2018
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT00451555
Start Date
April 11 2007
End Date
October 18 2018
Last Update
November 1 2019
Active Locations (21)
Enter a location and click search to find clinical trials sorted by distance.
1
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, 25030
2
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, 75231
3
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.
Saint-Herblain, France, 44805
4
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.
Toulouse, France, 31052