Metastatic Breast CancerPhase 2NCT00316199
Efficacy Study of Gemcitabine-Paclitaxel to Treat Metastatic Breast Cancer
A Phase 2 study testing gemcitabine and paclitaxel in people with Metastatic Breast Cancer, run by Eli Lilly and Company at 3 sites in China.
Trial summary
The purpose of this study is to determine the response rate to a gemcitabine-paclitaxel combination administered on a 3-weekly schedule in Chinese patients with unresectable, locally recurrent breast cancer or metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- gemcitabine and paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesChina
- Study dates
- Apr 2006to Apr 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients of Chinese origin with histologically or cytologically proven diagnosis of breast cancer.
- Unresectable, locally recurrent breast cancer or stage IV disease.
- Have at least one measurable lesion as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
- Performance Status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Scale
- Treatment with an anthracycline-based chemotherapy regimen in the adjuvant/neoadjuvant setting with subsequent disease relapse.
Who cannot join
- Prior chemotherapy for unresectable, locally advanced breast cancer or metastatic disease.
- Concurrent administration of any other tumor therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy.
- Known or suspected brain metastasis or second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
- Active infection or other serious condition.
- Pregnant or breastfeeding.
Trial locations and contacts
3 sites in 1 country.
China3 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.
Beijing, 100071
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.
Guangzhou, 510060
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.
Shanghai, 200032
About this study
Official title: Phase II Study of Gemcitabine-Paclitaxel 3-Weekly Schedule as First-Line Treatment in Metastatic Breast Cancer After Anthracycline Failure
The purpose of this study is to determine the response rate to a gemcitabine-paclitaxel combination administered on a 3-weekly schedule in Chinese patients with unresectable, locally recurrent breast cancer or metastatic breast cancer.
- Conditions
- Metastatic Breast Cancer
- Being tested
- gemcitabine, paclitaxel
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gemcitabineDrug
Also called LY188011, Gemzar
1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression
paclitaxelDrug
175 mg/m2, intravenous (IV), every 21 days until disease progression
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: gemcitabine; Drug: paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Overall Tumor Response
Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.
Measured: baseline to measured progressive disease (tumor assessments were performed every 2 cycles during study therapy, or 3 months during post-therapy until disease progression, or up to 12 months after enrollment)
Secondary outcomes (4)
Time to Treatment Failure
Defined as time from enrollment to the date of death due to any cause, measured disease progression, treatment discontinuation for undocumented progression, early treatment discontinuation for toxicity or other reason, or new anticancer treatment started.
Measured: baseline to stopping treatment
Progression-Free Survival
Defined as the time from enrollment to the date of objective disease progression or death on study, whichever occurs first. Censoring was determined based on US-FDA 2005 draft guidance on clinical endpoints.
Measured: baseline to measured progressive disease or death (tumor assessments were performed every 2 cycles during study therapy, or 3 months during post-therapy until disease progression, or up to 12 months after enrollment)
Duration of Response
Measured from the time of first documentation of complete response (CR) or partial response (PR), whichever status is first recorded, until the date of objective disease progression or death on study, whichever occurs first, with censoring defined in the same way as for progression-free survival.
Measured: time of response to measured progressive disease or death (tumor assessments were performed every 2 cycles during study therapy, or 3 months during post-therapy until disease progression, or up to 12 months after enrollment)
Overall Survival Probability
Original outcome was overall survival = time from date of enrollment to date of death due to any cause. Survival time was censored at date of last contact for participants who were still alive or lost to follow-up. Because only 8 participants had documented death while on study, results are reported as 6- and 12-month overall survival probability.
Measured: baseline to date of death from any cause
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2006 (estimated)
- Study startApr 2006
- Primary completionApr 2008
- Study completionApr 2008
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 Metastatic 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
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
- NCT00316199
- Sponsor's protocol ID
- 9803
- Other IDs
- B9E-MC-JHST
- Status last verified
- Jun 2009
- First submitted
- 18 Apr 2006
- Last updated
- 17 Jun 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Gemcitabine-Paclitaxel 3-Weekly Schedule as First-Line Treatment in Metastatic Breast Cancer After Anthracycline Failure
- ClinicalTrials.gov ID
- NCT00316199
- Acronym / sponsor ID
- 9803
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 20 Apr 2006 (estimated)
- Results
- Posted 11 Jun 2009
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 response rate to a gemcitabine-paclitaxel combination administered on a 3-weekly schedule in Chinese patients with unresectable, locally recurrent breast cancer or metastatic breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: gemcitabine, Drug: paclitaxel |
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)
- Female patients of Chinese origin with histologically or cytologically proven diagnosis of breast cancer.
- Unresectable, locally recurrent breast cancer or stage IV disease.
- Have at least one measurable lesion as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
- Performance Status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Scale
- Treatment with an anthracycline-based chemotherapy regimen in the adjuvant/neoadjuvant setting with subsequent disease relapse.
Key exclusion criteria (5 listed)
- Prior chemotherapy for unresectable, locally advanced breast cancer or metastatic disease.
- Concurrent administration of any other tumor therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy.
- Known or suspected brain metastasis or second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
- Active infection or other serious condition.
- Pregnant or breastfeeding.
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 |
|---|---|---|
| gemcitabineAlso: LY188011, Gemzar1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression | Drug | A |
| paclitaxel175 mg/m2, intravenous (IV), every 21 days until disease progression | Drug | A |
Primary outcome
Best Overall Tumor Response
Time frame: baseline to measured progressive disease (tumor assessments were performed every 2 cycles during study therapy, or 3 months during post-therapy until disease progression, or up to 12 months after enrollment)
Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.
4 secondary outcomes
Time to Treatment Failure
Time frame: baseline to stopping treatment
Progression-Free Survival
Time frame: baseline to measured progressive disease or death (tumor assessments were performed every 2 cycles during study therapy, or 3 months during post-therapy until disease progression, or up to 12 months after enrollment)
Duration of Response
Time frame: time of response to measured progressive disease or death (tumor assessments were performed every 2 cycles during study therapy, or 3 months during post-therapy until disease progression, or up to 12 months after enrollment)
Overall Survival Probability
Time frame: baseline to date of death from any cause
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2009.
- 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
3 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 gemcitabine and paclitaxel in people with Metastatic Breast Cancer, run by Eli Lilly and Company at 3 sites in China.
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 17 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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?
Yes. Results are posted in the registry (first posted 11 Jun 2009). 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?
Best Overall Tumor Response (time frame: baseline to measured progressive disease (tumor assessments were performed every 2 cycles during study therapy, or 3 months during post-therapy until disease progression, or up to 12 months after enrollment)). 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 17 Jun 2009.