Breast NeoplasmsPhase 2NCT00386087
Enzastaurin For Breast Cancer Patients Who Previously Received an Anthracycline and a Taxane Chemotherapy
A Phase 2 study testing Enzastaurin Hydrochloride in people with Breast Neoplasms, run by Eli Lilly and Company at 4 sites in United States.
Trial summary
The purpose of this study is to determine the effectiveness of enzastaurin in the treatment of patients with metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Enzastaurin Hydrochloride
- How many people
- 41 participants
- Where
- 4 sitesUnited States
- Study dates
- Nov 2006to Sep 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
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.
Boston, Massachusetts, 02115
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.
Indianapolis, Indiana, 46202
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.
Newark, Delaware, 19713
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.
South Bend, Indiana, 46601
About this study
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
The purpose of this study is to determine the effectiveness of enzastaurin in the treatment of patients with metastatic breast cancer.
- Conditions
- Breast Neoplasms
- Being tested
- Enzastaurin Hydrochloride
- Keywords
- Breast Cancer, Cancer of the Breast
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enzastaurin HydrochlorideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (3)
To evaluate the length of time that enzastaurin is able to effect control of the disease.
To evaluate the side effects of enzastaurin in patients with breast cancer
To determine whether changes in laboratory tests of patients treated with enzastaurin is associated with the response of their tumors to the drug.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2006 (estimated)
- Study startNov 2006
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00386087
- Sponsor's protocol ID
- 10517
- Other IDs
- H6Q-MC-S015
- Status last verified
- Apr 2008
- First submitted
- 6 Oct 2006
- Last updated
- 6 Jun 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00386087
- Acronym / sponsor ID
- 10517
- Conditions
- Breast Neoplasms
- Keywords
- Breast Cancer, Cancer of the Breast
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Study completion
- Sep 2007 (actual)
- First posted
- 11 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effectiveness of enzastaurin in the treatment of patients with metastatic breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enzastaurin Hydrochloride | Drug | – |
Primary outcome
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.
3 secondary outcomes
To evaluate the length of time that enzastaurin is able to effect control of the disease.
To evaluate the side effects of enzastaurin in patients with breast cancer
To determine whether changes in laboratory tests of patients treated with enzastaurin is associated with the response of their tumors to the drug.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2008.
- Hoosier Oncology GroupLink provided by the sponsor.
- Lilly Clinical Trial RegistryLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Enzastaurin Hydrochloride in people with Breast Neoplasms, run by Eli Lilly and Company at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2008.