Breast CancerPhase 2NCT00437294
Enzastaurin in Combination of Capecitabine to Treat Breast Cancer
A Phase 2 study testing enzastaurin and capecitabine in people with Breast Cancer, run by Eli Lilly and Company at 20 sites in 5 countries.
Trial summary
The purpose of this study is to determine whether the combination of enzastaurin and capecitabine is more effective than the combination of placebo and capecitabine in treating participants with breast cancer who were previously treated with an anthracycline and a taxane. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- enzastaurin and capecitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 20 sitesin 5 countries
- Study dates
- Mar 2007to Mar 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Have been diagnosed with metastatic or recurrent breast cancer.
- Have been previously treated with both an anthracycline and a taxane.
- Have not received more than two prior chemotherapy treatment programs.
- Have stopped any antitumoral hormonal treatment before you enroll in this study.
- Have a negative pregnancy blood test if menstruating or capable of becoming pregnant. You must use an approved birth control method during the study and for 3 months after stopping study treatment.
Who cannot join
- Cannot follow the study procedures (for example, you cannot swallow tablets).
- Are receiving another treatment for your cancer.
- Have received another experimental drug in the last 4 weeks.
- Have had serious heart disease within last 6 months.
- Are pregnant or breast-feeding.
Trial locations and contacts
20 sites in 5 countries.
20 sites in 5 countries
Australia6 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.
Caringbah, New South Wales, 2229
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Frankston, Victoria, 3199
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Garran, Australian Capital Territory, 2605
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Nedlands, Western Australia, 6009
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Subiaco, Western Australia, 6008
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Wollongong, New South Wales, 2500
France5 sites
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Avignon, 84082
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La Roche-sur-Yon, 85925
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Lyon, 69373
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Paris, 75651
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Saint-Brieuc, 22015
Mexico5 sites
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Acapulco, 39670
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Chihuahua City, 31238
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Cuernavaca, 62290
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Guadalajara, 44670
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Mexico City, 07300
Argentina3 sites
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Buenos Aires, 1430
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Resistencia, 3500
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Tucumain, 4000
South Africa1 site
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.
Durban, 4091
About this study
Official title: A Double-Blind, Randomized, Phase 2 Trial of Capecitabine Plus Enzastaurin Versus Capecitabine Plus Placebo in Patients With Metastatic or Recurrent Breast Cancer Previously Treated With an Anthracycline and a Taxane
The purpose of this study is to determine whether the combination of enzastaurin and capecitabine is more effective than the combination of placebo and capecitabine in treating participants with breast cancer who were previously treated with an anthracycline and a taxane.
- Conditions
- Breast Cancer
- Being tested
- enzastaurin, placebo, capecitabine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enzastaurinDrug
Also called LY317615
1125 milligrams (mg) loading dose then 500 mg, oral, daily, 21-day cycles until progressive disease
placeboDrug
oral, daily, 21-day cycles until progressive disease
capecitabineDrug
1250 mg/m^2, BID, days 1-14 of each 21-day cycle until progressive disease
| Study group | Role | What they receive |
|---|---|---|
| Capecitabine + Enzastaurin | Experimental | Not described Receives: Drug: enzastaurin; Drug: capecitabine |
| Capecitabine + Placebo | Placebo comparator | Not described Receives: Drug: placebo; Drug: capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
PFS was defined as the time from randomization to the first observation of disease progression or death due to any cause. For participants not known to have died as of the data cut-off date and who did not have progressive disease, PFS was censored at the date of last visit with adequate assessment. For participants who received subsequent anticancer therapy (after discontinuation from the study treatment) prior to disease progression or death, PFS was censored at the date of last visit with adequate assessment prior to the initiation of post-discontinuation anticancer therapy.
Measured: Randomization to measured progressive disease or death up to 14 months
Secondary outcomes (8)
Expression of Tumor Markers in Tissue Samples (Tumor Markers and Genes Evaluation)
Protein expression was planned to be measured using an Immunohistochemistry (IHC) assay to determine membrane and cytoplasmic phosphorylated glycogen synthase kinase 3 beta (pGSK3B), nuclear phosphorylated adenosine 3'5'-cyclic monophosphate (cAMP) response-element binding protein (pCREB), cytoplasmic pCREB, protein kinase C beta 2 (PKCB2), cytoplasmic phospho S6 (pS6), and cytoplasmic phosphatase and tensin homolog (PTEN) IHC H-scores. Tumor tissue samples were to be scored using a 0 (negative, no staining) to 3+ (brightest staining) scoring system for cytoplasmic and nuclear staining, and H- scores calculated using formula: 1x(percentage of cells stained 1+) + 2x(percentage of cells stained 2+) + 3x(percentage of cells stained 3+) .
Measured: Randomization, Cycle 2, end of study
Pharmacokinetics: Area Under the Concentration Versus Time Curve During One Dosing Interval at Steady State
Area Under the Concentration versus time curve during 1 dosing interval at steady state (AUCτ,ss) for Cycle 2 Day 1 for Enzastaurin, its metabolite LY326020 and total analytes (enzastaurin + LY326020). AUCτ,ss was calculated using concentration versus time data by post hoc estimation of enzastaurin, its metabolite LY326020, and total analytes (enzastaurin + LY326020).
Measured: From pre-dose to 24 hours post-dose on Day 1 of Cycle 2
Pharmacokinetics: Area Under the Concentration Curve Versus Time From Time 0 to Last Quantifiable Value (AUC0-tlast) of Capecitabine
AUC0-tlast for Capecitabine, 5'-deoxy-5-fluorouridine (5'-DFUR) and 5-fluorouracil (5-FU) was calculated from the plasma concentration-time data for each analyte for Cycle 2, Day 1.
Measured: Pre-dose to 6 hours post-dose on Day 1 of Cycle 2
Pharmacokinetics: Maximum Observed Concentration (Cmax) of Capecitabine
Cmax for Capecitabine, 5'-deoxy-5-fluorouridine (5'-DFUR) and its metabolites 5-fluorouracil (5-FU) was calculated from the plasma concentration-time data for each analyte for Day 1 of Cycle 2.
Measured: From pre-dose to 6 hours post-dose on Day 1 of Cycle 2
Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate)
Response rate was defined as percent of participants with objective response [CR or PR] over randomized and treated participants using the Response Evaluation Criteria in Solid Tumors (RECIST v1.0) Guidelines. CR was defined as the disappearance of all tumor lesions. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum of LDs or complete disappearance of target lesions, with persistence (but not worsening) of one or more non-target lesions. No new lesions may have appeared.
Measured: Randomization to last visit (up to 9.66 months)
Duration of Response (DOR)
The DOR was defined as the time from first objective status assessment of complete response (CR) or partial response (PR) to the first time of progression or death as a result of any cause. According to the Response Evaluation Criteria in Solid Tumors (RECIST V1.0) criteria, CR was the disappearance of all tumor lesions. PR was at least a 30% decrease in the sum of the longest diameter (LD) of target lesions or complete disappearance of target lesions, with persistence (but not worsening) of 1 or more non-target lesions, with occurrence of no new lesions. For participants not known to have died as of the data cut-off date and who did not have progressive disease, DOR was censored at the date of last visit with adequate assessment. For participants who received subsequent anticancer therapy (after discontinuation from the study treatment) prior to disease progression or death, DOR was censored at the date of last visit with adequate assessment.
Measured: Randomization to last visit (up to 9.66 months)
Overall Survival (OS)
OS was defined as the time in months from the date of study enrollment to the date of death from any cause. For participants not known to have died as of the cut-off date, OS was censored at the last contact date.
Measured: Randomization to date of death from any cause up to 20.83 months
Pharmacology Toxicity and Adverse Events (AEs)
Data presented are the number of participants who experienced serious AEs, AEs, death due to progressive disease (PD), death due to AEs while on treatment and death during the 30-day post-treatment. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
Measured: Baseline to study completion [Cycle 19 (21 days/cycle) and 30-day safety follow-up]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2007 (estimated)
- Study startMar 2007
- Primary completionMar 2009
- Study completionMar 2009
Why it stopped: Lack of efficacy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- 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
- NCT00437294
- Sponsor's protocol ID
- 10536
- Other IDs
- H6Q-MC-S035
- Status last verified
- Jul 2020
- First submitted
- 16 Feb 2007
- Last updated
- 10 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Clemons M, Joy AA, Abdulnabi R, Kotliar M, Lynch J, Jordaan JP, Iscoe N, Gelmon K. Phase II, double-blind, randomized trial of capecitabine plus enzastaurin versus capecitabine plus placebo in patients with metastatic or recurrent breast cancer after prior anthracycline and taxane therapy. Breast Cancer Res Treat. 2010 Nov;124(1):177-86. doi: 10.1007/s10549-010-1152-0. Epub 2010 Sep 3.
PubMed 20814815
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Phase 2 Trial of Capecitabine Plus Enzastaurin Versus Capecitabine Plus Placebo in Patients With Metastatic or Recurrent Breast Cancer Previously Treated With an Anthracycline and a Taxane
- ClinicalTrials.gov ID
- NCT00437294
- Acronym / sponsor ID
- 10536
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of efficacy
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 19 Feb 2007 (estimated)
- Results
- Posted 10 Aug 2020
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 whether the combination of enzastaurin and capecitabine is more effective than the combination of placebo and capecitabine in treating participants with breast cancer who were previously treated with an anthracycline and a taxane.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capecitabine + Enzastaurin | Experimental | Drug: enzastaurin, Drug: capecitabine |
| Capecitabine + Placebo | Placebo comparator | Drug: placebo, Drug: capecitabine |
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)
- Have been diagnosed with metastatic or recurrent breast cancer.
- Have been previously treated with both an anthracycline and a taxane.
- Have not received more than two prior chemotherapy treatment programs.
- Have stopped any antitumoral hormonal treatment before you enroll in this study.
- Have a negative pregnancy blood test if menstruating or capable of becoming pregnant. You must use an approved birth control method during the study and for 3 months after stopping study treatment.
Key exclusion criteria (5 listed)
- Cannot follow the study procedures (for example, you cannot swallow tablets).
- Are receiving another treatment for your cancer.
- Have received another experimental drug in the last 4 weeks.
- Have had serious heart disease within last 6 months.
- Are pregnant or breast-feeding.
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 |
|---|---|---|
| enzastaurinAlso: LY3176151125 milligrams (mg) loading dose then 500 mg, oral, daily, 21-day cycles until progressive disease | Drug | Capecitabine + Enzastaurin |
| placebooral, daily, 21-day cycles until progressive disease | Drug | Capecitabine + Placebo |
| capecitabine1250 mg/m^2, BID, days 1-14 of each 21-day cycle until progressive disease | Drug | Capecitabine + Enzastaurin, Capecitabine + Placebo |
Primary outcome
Progression Free Survival (PFS)
Time frame: Randomization to measured progressive disease or death up to 14 months
PFS was defined as the time from randomization to the first observation of disease progression or death due to any cause. For participants not known to have died as of the data cut-off date and who did not have progressive disease, PFS was censored at the date of last visit with adequate assessment. For participants who received subsequent anticancer therapy (after discontinuation from the study treatment) prior to disease progression or death, PFS was censored at the date of last visit with adequate assessment prior to the initiation of post-discontinuation anticancer therapy.
8 secondary outcomes
Expression of Tumor Markers in Tissue Samples (Tumor Markers and Genes Evaluation)
Time frame: Randomization, Cycle 2, end of study
Pharmacokinetics: Area Under the Concentration Versus Time Curve During One Dosing Interval at Steady State
Time frame: From pre-dose to 24 hours post-dose on Day 1 of Cycle 2
Pharmacokinetics: Area Under the Concentration Curve Versus Time From Time 0 to Last Quantifiable Value (AUC0-tlast) of Capecitabine
Time frame: Pre-dose to 6 hours post-dose on Day 1 of Cycle 2
Pharmacokinetics: Maximum Observed Concentration (Cmax) of Capecitabine
Time frame: From pre-dose to 6 hours post-dose on Day 1 of Cycle 2
Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate)
Time frame: Randomization to last visit (up to 9.66 months)
Duration of Response (DOR)
Time frame: Randomization to last visit (up to 9.66 months)
Overall Survival (OS)
Time frame: Randomization to date of death from any cause up to 20.83 months
Pharmacology Toxicity and Adverse Events (AEs)
Time frame: Baseline to study completion [Cycle 19 (21 days/cycle) and 30-day safety follow-up]
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20814815Clemons M, Joy AA, Abdulnabi R, Kotliar M, Lynch J, Jordaan JP, Iscoe N, Gelmon K. Phase II, double-blind, randomized trial of capecitabine plus enzastaurin versus capecitabine plus placebo in patients with metastatic or recurrent breast cancer after prior anthracycline and taxane therapy. Breast Cancer Res Treat. 2010 Nov;124(1):177-86. doi: 10.1007/s10549-010-1152-0. Epub 2010 Sep 3.
- 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
20 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing enzastaurin and capecitabine in people with Breast Cancer, run by Eli Lilly and Company at 20 sites in 5 countries.
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: stopped early, as of the sponsor's last update on 10 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Australia, France, Mexico, Argentina, South Africa. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 10 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Progression Free Survival (PFS) (time frame: Randomization to measured progressive disease or death up to 14 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00437294, which also lists 1 linked publication.
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 10 Aug 2020.