Breast CancerPhase 2NCT00536939
Trial of Paclitaxel, Bevacizumab, and Enzastaurin Versus Paclitaxel, Bevacizumab and Placebo for Breast Cancer
A Phase 2 study testing Enzastaurin, Bevacizumab and Paclitaxel in people with Breast Cancer, run by Eli Lilly and Company at 7 sites in United States.
Trial summary
The purpose of this study is to determine efficacy and safety of paclitaxel, bevacizumab and enzastaurin versus paclitaxel, bevacizumab, and placebo in participants who are diagnosed with locally recurrent or metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Enzastaurin, Bevacizumab and Paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 7 sitesUnited States
- Study dates
- Nov 2007to Mar 2008
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have signed an inform consent document
- Have histologic or cytologic diagnosis of breast cancer with evidence of unresectable locally recurrent or metastatic disease
- Have not received any prior chemotherapy for locally recurrent or metastatic disease
- Have not had adjuvant or neoadjuvant taxane therapy within 12 months prior to assignment to study treatment
- Age 18 years or older at time of informed consent
Who cannot join
- Have any clinical evidence of central nervous system (CNS) metastases
- Have a history of seizure
- Have had a major surgical procedure within 4 weeks prior to assignment to study treatment
- Have had a minor surgical procedure, placement of an access device, or fine needle aspiration within 7 days prior to assignment to study treatment
- Have symptomatic peripheral vascular disease
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 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.
Fort Wayne, Indiana, 46815
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.
Galesburg, Illinois, 61401
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.
Goshen, Indiana, 46526
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.
Lafayette, Indiana, 47905
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.
Omaha, Nebraska, 68114
About this study
Official title: A Randomized, Double-Blind, Phase 2 Trial of Paclitaxel Plus Bevacizumab and Enzastaurin Versus Paclitaxel Plus Bevacizumab and Placebo for Locally Recurrent or Metastatic Breast Cancer
The purpose of this study is to determine efficacy and safety of paclitaxel, bevacizumab and enzastaurin versus paclitaxel, bevacizumab, and placebo in participants who are diagnosed with locally recurrent or metastatic breast cancer.
- Conditions
- Breast Cancer
- Being tested
- Enzastaurin, Bevacizumab, Paclitaxel, Placebo
- 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 on Day 1 of Cycle 1 only then 500 mg oral once daily, until disease progression
BevacizumabDrug
10 milligrams per kilogram (mg/kg) intravenously, Days 1 and 15 every 28 days, until disease progression
PaclitaxelDrug
90 milligrams per square meter (mg/m^2), intravenously, Days 1 ,8, and 15 every 28 days until disease progression
PlaceboDrug
Oral, daily, until disease progression
| Study group | Role | What they receive |
|---|---|---|
| Enzastaurin + Bevacizumab + Paclitaxel | Experimental | Participants randomized to this arm (Arm A) will receive enzastaurin, paclitaxel and bevacizumab until disease progression.
Prior to randomization, a safety lead-in will be conducted in 6 participants who will be treated according to Arm A for 2 cycles (1 cycle = 28 days). Only after an acceptable safety analysis of the safety lead-in, will other participants be randomized to Phase 2 (either Arm A or Arm B). In Phase 2, participants from the safety lead-in will continue treatment according to Enzastaurin + Bevacizumab + Paclitaxel (Arm A). Receives: Drug: Enzastaurin; Drug: Bevacizumab; Drug: Paclitaxel |
| Bevacizumab + Paclitaxel + Placebo | Placebo comparator | Participants randomized to this arm (Arm B) will receive bevacizumab, paclitaxel and placebo until disease progression. Receives: Drug: Bevacizumab; Drug: Paclitaxel; Drug: Placebo |
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 the date of study enrollment to the first date of objectively determined progressive disease (PD) or death from any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST version 1.0). PD is ≥20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. For participants not known to have died and who did not have PD, PFS was censored at the date of the last progression-free assessment. For participants who received subsequent systemic anticancer therapy (after discontinuation from the study treatment) prior to disease progression or death, PFS was censored at the date of last progression-free assessment prior to the initiation of post-discontinuation systemic anticancer therapy. No participant completed a full cycle of therapy and thus no formal analysis was performed.
Measured: Baseline to measured PD (up to 15 days)
Secondary outcomes (2)
Overall Response Rate (ORR)
ORR was defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR), assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST version 1.0). CR was defined as the disappearance of all tumor lesions; PR was defined as either ≥30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LDs or complete disappearance of target lesions, with persistence (but not worsening) of 1 or more non-target lesions. In either case of PR, no new lesions should have appeared. The percentage of participants with ORR was calculated as a total number of participants with CR or PR from the start of study treatment until disease progression or recurrence divided by the total number of participants treated, then multiplied by 100. No participant completed a full cycle of therapy and thus no formal analysis was performed.
Measured: Baseline to measured Progressive disease (up to 15 days)
Number of Participants With Adverse Events (AEs) or Any Serious AEs (SAEs)
A summary of SAEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.
Measured: Baseline to study completion (Day 15) plus 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 posted28 Sep 2007 (estimated)
- Study startNov 2007
- Primary completionMar 2008
- Study completionMar 2008
Why it stopped: Study has been terminated due to slow enrollment
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.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Genentech, Inc.
- 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
- NCT00536939
- Sponsor's protocol ID
- 11396
- Other IDs
- H6Q-MC-S038
- Status last verified
- Sep 2020
- First submitted
- 26 Sep 2007
- Last updated
- 24 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Phase 2 Trial of Paclitaxel Plus Bevacizumab and Enzastaurin Versus Paclitaxel Plus Bevacizumab and Placebo for Locally Recurrent or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00536939
- Acronym / sponsor ID
- 11396
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study has been terminated due to slow enrollment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Genentech, Inc.
- Study start
- Nov 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 28 Sep 2007 (estimated)
- Results
- Posted 24 Sep 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 efficacy and safety of paclitaxel, bevacizumab and enzastaurin versus paclitaxel, bevacizumab, and placebo in participants who are diagnosed with locally recurrent or metastatic breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enzastaurin + Bevacizumab + Paclitaxel | Experimental | Drug: Enzastaurin, Drug: Bevacizumab, Drug: PaclitaxelParticipants randomized to this arm (Arm A) will receive enzastaurin, paclitaxel and bevacizumab until disease progression. Prior to randomization, a safety lead-in will be conducted in 6 participants who will be treated according to Arm A for 2 cycles (1 cycle = 28 days). Only after an acceptable safety analysis of the safety lead-in, will other participants be randomized to Phase 2 (either Arm A or Arm B). In Phase 2, participants from the safety lead-in will continue treatment according to Enzastaurin + Bevacizumab + Paclitaxel (Arm A). |
| Bevacizumab + Paclitaxel + Placebo | Placebo comparator | Drug: Bevacizumab, Drug: Paclitaxel, Drug: PlaceboParticipants randomized to this arm (Arm B) will receive bevacizumab, paclitaxel and placebo until disease progression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must have signed an inform consent document
- Have histologic or cytologic diagnosis of breast cancer with evidence of unresectable locally recurrent or metastatic disease
- Have not received any prior chemotherapy for locally recurrent or metastatic disease
- Have not had adjuvant or neoadjuvant taxane therapy within 12 months prior to assignment to study treatment
- Age 18 years or older at time of informed consent
Key exclusion criteria (5 listed)
- Have any clinical evidence of central nervous system (CNS) metastases
- Have a history of seizure
- Have had a major surgical procedure within 4 weeks prior to assignment to study treatment
- Have had a minor surgical procedure, placement of an access device, or fine needle aspiration within 7 days prior to assignment to study treatment
- Have symptomatic peripheral vascular disease
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 on Day 1 of Cycle 1 only then 500 mg oral once daily, until disease progression | Drug | Enzastaurin + Bevacizumab + Paclitaxel |
| Bevacizumab10 milligrams per kilogram (mg/kg) intravenously, Days 1 and 15 every 28 days, until disease progression | Drug | Bevacizumab + Paclitaxel + Placebo, Enzastaurin + Bevacizumab + Paclitaxel |
| Paclitaxel90 milligrams per square meter (mg/m^2), intravenously, Days 1 ,8, and 15 every 28 days until disease progression | Drug | Bevacizumab + Paclitaxel + Placebo, Enzastaurin + Bevacizumab + Paclitaxel |
| PlaceboOral, daily, until disease progression | Drug | Bevacizumab + Paclitaxel + Placebo |
Primary outcome
Progression Free Survival (PFS)
Time frame: Baseline to measured PD (up to 15 days)
PFS was defined as the time from the date of study enrollment to the first date of objectively determined progressive disease (PD) or death from any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST version 1.0). PD is ≥20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. For participants not known to have died and who did not have PD, PFS was censored at the date of the last progression-free assessment. For participants who received subsequent systemic anticancer therapy (after discontinuation from the study treatment) prior to disease progression or death, PFS was censored at the date of last progression-free assessment prior to the initiation of post-discontinuation systemic anticancer therapy. No participant completed a full cycle of therapy and thus no formal analysis was performed.
2 secondary outcomes
Overall Response Rate (ORR)
Time frame: Baseline to measured Progressive disease (up to 15 days)
Number of Participants With Adverse Events (AEs) or Any Serious AEs (SAEs)
Time frame: Baseline to study completion (Day 15) plus 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 24 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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
7 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, Bevacizumab and Paclitaxel in people with Breast Cancer, run by Eli Lilly and Company at 7 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: stopped early, as of the sponsor's last update on 24 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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. 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 24 Sep 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: Baseline to measured PD (up to 15 days)). 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 24 Sep 2020.