Clinical trial NCT00386087: Enzastaurin For Breast Cancer Patients Who Previously Received an Anthracycline and a Taxane Chemotherapy
Official title: A Phase II Study of Oral Enzastaurin in Patients With Metastatic Breast Cancer Previously Treated With an Anthracycline and a Taxane-Containing Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Neoplasms
Keywords: Breast Cancer
Cancer of the Breast
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2006-10-11
Enrollment: 41
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effectiveness of enzastaurin in the treatment of patients with metastatic breast cancer.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of metastatic breast cancer or recurrent breast cancer where surgery can not be done for curative intent
* Have received prior therapy with an anthracycline (class of drugs) and a taxane (class of drugs).
* Tumors must not be positive for HER2, but if positive, the treatment plan should not include further treatment with the drug Herceptin.
* Disease that can be definitely measured on Cat Scans or other radiological tests.
* May have received high dose chemotherapy for autologous stem cell support greater than or equal to 6 months of starting this study.

Exclusion Criteria:

* More than 2 chemotherapy regimens for metastatic or locally recurrent disease.
* Have brain cancer from breast cancer
* Pregnant or breastfeeding
* Have an inability to swallow tablets
* Within 6 months have had a serious heart condition

Primary outcomes:
measure: To determine the effects of enzastaurin in the treatment of patients with breast cancer by measuring its ability to reduce the size of the tumor or prevent further increases in tumor size.
Secondary outcomes:
measure: To evaluate the length of time that enzastaurin is able to effect control of the disease.
measure: To evaluate the side effects of enzastaurin in patients with breast cancer
measure: To determine whether changes in laboratory tests of patients treated with enzastaurin is associated with the response of their tumors to the drug.
Other outcomes:
Locations:
city: Newark
country: United States
facility: 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.
state: Delaware
city: Indianapolis
country: United States
facility: 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.
state: Indiana
city: South Bend
country: United States
facility: 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.
state: Indiana
city: Boston
country: United States
facility: 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.
state: Massachusetts
Study officials:
affiliation: Eli Lilly and Company
name: 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
References: