Metastatic Breast CancerPhase 2NCT00334802

Combination Chemotherapy of Gemcitabine and Paclitaxel for Metastatic Breast Cancer

A Phase 2 study testing gemcitabine and paclitaxel in people with Metastatic Breast Cancer, run by Eli Lilly and Company at 15 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To investigate efficacy, safety and PK of gemcitabine and paclitaxel combination in patients with metastatic breast cancer after adjuvant/neo-adjuvant chemotherapy with anthracycline regimen Read more about this study

Who is it for?: Ages 20 to 74 years, 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: 62 participants
Where: 15 sitesJapan
Study dates: Jun 2006to Mar 2010
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 20 to 74 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Histologically and/or cytologically confirmed breast cancer
Received adjuvant/neo-adjuvant chemotherapy for breast cancer with anthracycline regimen
To have at least one measurable region
Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
To have adequate organ function (bone marrow, liver and renal function)

Who cannot join

To have interstitial pneumonia or pulmonary fibrosis
To have inflammatory breast cancer
Within 28 days after the latest chemotherapy or radiotherapy, 14 days after the latest hormonal/immunotherapy or 7 days after surgery
To have brain metastases with symptoms
To have severe complication (cardiac infarction, infection, drug hypersensitivity or diabetes)

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

Japan15 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.
Aichi, 464-8681
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.
Chiba, 296-8602
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.
Ehime, 790-0007
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.
Fukuoka, 814-0180
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.
Gunma, 373-8550
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Hiroshima, 737-0023
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Hokkaido, 060-0006
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Kagoshima, 892-0833
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.
Kanagawa, 259-1193
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.
Kumamoto, 862-8505
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.
Numakunai, 020-8505
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.
Osaka, 590-0064
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.
Saitama, 338-8553
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.
Shizuoka, 430-8558
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.
Tokyo, 104-8560

Other trials in Japan

About this study

Official title: Combination Study of LY188011 and Paclitaxel in Patients With Metastatic/Recurrent Breast Cancer After Neo-adjuvant/Adjuvant Chemotherapy With Anthracycline

To investigate efficacy, safety and PK of gemcitabine and paclitaxel combination in patients with metastatic breast cancer after adjuvant/neo-adjuvant chemotherapy with anthracycline regimen

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
Phase 1: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles (dose escalation)
Phase 2: dose determined by phase 1
paclitaxelDrug
Phase 1: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
Phase 2: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles

Study groups in NCT00334802
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.

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. Responders are patients with complete response or partial response.
Measured: baseline to measured progressive disease

Secondary outcomes (6)

Duration of Response
The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.
Measured: time of response to progressive disease
Time to Progressive Disease
Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause.
Measured: baseline to measured progressive disease
Number of Participants Alive at One Year (1-Year Survival)
Measured: baseline to date of death from any cause, evaluated at 1 year
Pharmacokinetics - Maximum Plasma Concentration (Cmax)
Maximum plasma concentration of gemcitabine plus paclitaxel on Day 1, Cycle 1, and gemcitabine monotherapy on Day 8, Cycle 1.
Measured: cycle 1, day 1 (0 minutes, 3, 3.25, 3.5, 3.58, 3.75, 4, 4.5, 5 hours) and 8 (0, 15, 30, 35, 45, 60, 90, 120 minutes)
Pharmacokinetics - Area Under the Concentration Curve (AUC)
Area under the concentration curve from time zero to infinity.
Measured: cycle 1, day 1 (0 minutes, 3, 3.25, 3.5, 3.58, 3.75, 4, 4.5, 5 hours) and 8 (0, 15, 30, 35, 45, 60, 90, 120 minutes)
Pharmacokinetics - Half Life (t½)
Apparent elimination half-life.
Measured: cycle 1, day 1 (0 minutes, 3, 3.25, 3.5, 3.58, 3.75, 4, 4.5, 5 hours) and 8 (0, 15, 30, 35, 45, 60, 90, 120 minutes)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2006Mar 2010

First posted8 Jun 2006 (estimated)
Study startJun 2006
Primary completionFeb 2008
Study completionMar 2010

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: 62 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00334802
Sponsor's protocol ID: 9066
Other IDs: B9E-JE-MB22
Status last verified: Mar 2010
First submitted: 6 Jun 2006
Last updated: 16 Mar 2010
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Metastatic Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Combination Study of LY188011 and Paclitaxel in Patients With Metastatic/Recurrent Breast Cancer After Neo-adjuvant/Adjuvant Chemotherapy With Anthracycline
ClinicalTrials.gov ID: NCT00334802
Acronym / sponsor ID: 9066
Conditions: Metastatic Breast Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 62 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Jun 2006
Primary completion: Feb 2008 (actual)
Study completion: Mar 2010 (actual)
First posted: 8 Jun 2006 (estimated)
Results: Posted 20 Jul 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To investigate efficacy, safety and PK of gemcitabine and paclitaxel combination in patients with metastatic breast cancer after adjuvant/neo-adjuvant chemotherapy with anthracycline regimen

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: 20 to 74 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Histologically and/or cytologically confirmed breast cancer
Received adjuvant/neo-adjuvant chemotherapy for breast cancer with anthracycline regimen
To have at least one measurable region
Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
To have adequate organ function (bone marrow, liver and renal function)

Key exclusion criteria (5 listed)

To have interstitial pneumonia or pulmonary fibrosis
To have inflammatory breast cancer
Within 28 days after the latest chemotherapy or radiotherapy, 14 days after the latest hormonal/immunotherapy or 7 days after surgery
To have brain metastases with symptoms
To have severe complication (cardiac infarction, infection, drug hypersensitivity or diabetes)

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, GemzarPhase 1: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles (dose escalation) Phase 2: dose determined by phase 1	Drug	A
paclitaxelPhase 1: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles Phase 2: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles	Drug	A

Primary outcome

Tumor Response
Time frame: baseline to measured progressive disease
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. Responders are patients with complete response or partial response.

6 secondary outcomes

Duration of Response
Time frame: time of response to progressive disease
Time to Progressive Disease
Time frame: baseline to measured progressive disease
Number of Participants Alive at One Year (1-Year Survival)
Time frame: baseline to date of death from any cause, evaluated at 1 year
Pharmacokinetics - Maximum Plasma Concentration (Cmax)
Time frame: cycle 1, day 1 (0 minutes, 3, 3.25, 3.5, 3.58, 3.75, 4, 4.5, 5 hours) and 8 (0, 15, 30, 35, 45, 60, 90, 120 minutes)
Pharmacokinetics - Area Under the Concentration Curve (AUC)
Time frame: cycle 1, day 1 (0 minutes, 3, 3.25, 3.5, 3.58, 3.75, 4, 4.5, 5 hours) and 8 (0, 15, 30, 35, 45, 60, 90, 120 minutes)
Pharmacokinetics - Half Life (t½)
Time frame: cycle 1, day 1 (0 minutes, 3, 3.25, 3.5, 3.58, 3.75, 4, 4.5, 5 hours) and 8 (0, 15, 30, 35, 45, 60, 90, 120 minutes)

Results and safety

Results posted to the registry on 20 Jul 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dose Level 1	6	0
Dose Level 2	56	16

Primary outcome: Tumor Response

Time frame: baseline to measured progressive disease. Number. Unit: participants

Measure	Dose Level 1 n = 6	Dose Level 2 n = 56
Complete Response	0	0
Partial Response	3	25
Stable Disease	1	17
Progressive Disease	1	11
Not Evaluable	1	3

Dose Level 1: p = 0.169, t-test, 2 sided
Dose Level 2: p = 0.001, t-test, 2 sided

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dose Level 1	1 of ?	6 of ?	Not reported
Dose Level 2	3 of ?	56 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Lilly Clinical Trial RegistryLink provided by the sponsor.

Related trials for Metastatic Breast Cancer

RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruiting
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
Breast Cancer, Breast Neoplasms
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
RecruitingPhase 1/2
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
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RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma

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

15 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 15 sites in Japan.

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 16 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Japan. 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 20 Jul 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?

Tumor Response (time frame: baseline to measured progressive disease). 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 NCT00334802.

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 16 Mar 2010.