Breast CancerPhase 2NCT00191854

Gemcitabine Combinations in Metastatic Breast Cancer (MBC), 1st Line

A Phase 2 study testing gemcitabine, paclitaxel and carboplatin in people with Breast Cancer, run by Eli Lilly and Company at 18 sites in 6 countries.

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

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Cancer
What is being tested?: gemcitabine, paclitaxel and carboplatin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 147 participants
Where: 18 sitesin 6 countries
Study dates: Mar 2005to Nov 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

Female patients with histological or cytological proven diagnosis of breast cancer
Stage IV disease
Performance Status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Scale
Patients had to have previously received anthracycline based regimens as a adjuvant therapy or neo-adjuvant chemotherapy and then progressed and developed metastatic disease
Adequate organ function

Who cannot join

Prior chemotherapy for metastatic disease
Previous radiation therapy is allowed but must not have included whole pelvis radiation
Known or suspected brain metastasis. Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator
Concurrent administration of any other tumor therapy, including cytotoxic chemotherapy, hormonal therapy and immunotherapy (including trastuzumab (Herceptin))
Peripheral neuropathy of Common Toxicity Criteria (CTC) Grade greater than 1. History of significant neurological or mental disorder, including seizures or dementia

Trial locations and contacts

18 sites in 6 countries.

Country

City, postcode or hospital

18 sites in 6 countries

India5 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.
Delhi, 110085
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Kolkata, 700053
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Ludhiana, 141001
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Mumbai, 400016
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Pune, 411001

Other trials in India

China4 sites

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Beijing, 100071
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Hangzhou, 310016
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Nanjing, 210009
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Wuhan, 430030

Other trials in China

Mexico3 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.
Cuernavaca, 62200
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.
Mexico City, 01120
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.
Villahermosa, 86090

Other trials in Mexico

Turkey (Türkiye)3 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.
Antalya
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.
Gaziantep
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.
Kayseri, 38039

Other trials in Turkey (Türkiye)

Brazil2 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.
Santo André, 09060-020
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.
São Paulo, 05403-900

Other trials in Brazil

South Korea1 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.
Seoul, 138-736

Other trials in South Korea

About this study

Official title: Randomized Phase II Study of Biweekly Gemcitabine-Paclitaxel, Biweekly Gemcitabine-Carboplatin and Biweekly Gemcitabine-Cisplatin as First-Line Treatment in Metastatic Breast Cancer After Anthracycline Failure

The gemcitabine-paclitaxel and gemcitabine-platinum combinations have shown promise in the treatments of MBC; however, the optimal dosing schedules for these combinations have not yet been determined. The primary objective of this study is to compare the response rates of the gemcitabine-paclitaxel, gemcitabine-carboplatin, and gemcitabine-cisplatin combinations when administered on a biweekly schedule in metastatic breast cancer.

Conditions: Breast Cancer
Being tested: gemcitabine, paclitaxel, carboplatin, cisplatin
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
2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles
paclitaxelDrug
150 mg/m2, IV, every 14 days x 8 cycles
carboplatinDrug
Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles
cisplatinDrug
50 mg/m2, IV, every 14 days x 8 cycles

Study groups in NCT00191854
Study group	Role	What they receive
Gemcitabine + Paclitaxel	Experimental	gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles. paclitaxel: 150 mg/m2, IV, every 14 days x 8 cycles. Receives: Drug: gemcitabine; Drug: paclitaxel
Gemcitabine + Carboplatin	Experimental	gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles. carboplatin: Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles. Receives: Drug: gemcitabine; Drug: carboplatin
Gemcitabine + Cisplatin	Experimental	gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles. cisplatin: 50 mg/m2, IV, every 14 days x 8 cycles Receives: Drug: gemcitabine; Drug: cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

Best Overall Response
Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.
Measured: baseline to measured progressive disease (tumor assessments were performed every 4 cycles during study therapy, or 3 months during post-therapy until disease progression, death or up to 24 months after randomization)

Secondary outcomes (4)

Number of Participants With a Time to Treatment Failure (TTTF) Event
TTTF event was defined as documented disease progression, death on study, start of non-protocol-specified anticancer therapy, or therapy discontinuation due to toxicity. TTTF for patients who were still participating in study without treatment failure at time of analysis were treated as censored at date of last tumor assessment. TTTF for patients who had discontinued from therapy for reasons other than toxicity and who did not experience treatment failure prior to therapy discontinuation were treated as censored on day of study discontinuation.
Measured: randomization to date of documented disease progression, death on study, start of non-protocol-specified anticancer therapy, or therapy discontinuation due to toxicity, whichever occurred first (up to 6 months)
Progression Free Survival (PFS)
PFS was defined as the time from randomizaton to the date of documented disease progression or death on study, whichever occurred first. PFS for participants who discontinued from the study or who had not progressed at the time of analysis were treated as censored at the date of the last tumor assessment.
Measured: baseline to measured progressive disease or death (tumor assessments were performed every 4 cycles during study therapy, or 3 months during post-therapy until disease progression, death, or up to 24 months after randomization)
Duration of Response
Duration of response was measured from time of first documentation of complete response (disappearance of all target lesions) or partial response (30% decrease in sum of longest diameter of target lesions), until date of PFS. Duration of response was censored on day of last tumor assessment for patients who had not progressed or who had discontinued study at time of analysis, and for cases where investigator determined patient had progressive disease and discontinued study therapy and/or started a new, non-protocol-specified anti-cancer therapy before documented disease progression.
Measured: time of response to progressive disease or death (tumor assessments were performed every 4 cycles during study therapy, or 3 months during post-therapy until disease progression, death, or up to 24 months after randomization)
Overall Survival
Overall survival time is defined as the time from the date of randomization to date of death due to any cause. Survival time is censored at the date of last contact for patients who are still alive or lost to follow-up.
Measured: baseline to date of death from any cause (up to 34 months)

Timeline

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

Mar 2005Nov 2009

First posted19 Sep 2005 (estimated)
Study startMar 2005
Primary completionAug 2008
Study completionNov 2009

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: None (open label)
Enrolment: 147 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00191854
Sponsor's protocol ID: 7451
Other IDs: B9E-AA-S355
Status last verified: Feb 2010
First submitted: 12 Sep 2005
Last updated: 2 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 Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Phase II Study of Biweekly Gemcitabine-Paclitaxel, Biweekly Gemcitabine-Carboplatin and Biweekly Gemcitabine-Cisplatin as First-Line Treatment in Metastatic Breast Cancer After Anthracycline Failure
ClinicalTrials.gov ID: NCT00191854
Acronym / sponsor ID: 7451
Conditions: Breast Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 147 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Mar 2005
Primary completion: Aug 2008 (actual)
Study completion: Nov 2009 (actual)
First posted: 19 Sep 2005 (estimated)
Results: Posted 31 Aug 2009

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Gemcitabine + Paclitaxel	Experimental	Drug: gemcitabine, Drug: paclitaxelgemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles. paclitaxel: 150 mg/m2, IV, every 14 days x 8 cycles.
Gemcitabine + Carboplatin	Experimental	Drug: gemcitabine, Drug: carboplatingemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles. carboplatin: Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles.
Gemcitabine + Cisplatin	Experimental	Drug: gemcitabine, Drug: cisplatingemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles. cisplatin: 50 mg/m2, IV, every 14 days x 8 cycles

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 with histological or cytological proven diagnosis of breast cancer
Stage IV disease
Performance Status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Scale
Patients had to have previously received anthracycline based regimens as a adjuvant therapy or neo-adjuvant chemotherapy and then progressed and developed metastatic disease
Adequate organ function

Key exclusion criteria (5 listed)

Prior chemotherapy for metastatic disease
Previous radiation therapy is allowed but must not have included whole pelvis radiation
Known or suspected brain metastasis. Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator
Concurrent administration of any other tumor therapy, including cytotoxic chemotherapy, hormonal therapy and immunotherapy (including trastuzumab (Herceptin))
Peripheral neuropathy of Common Toxicity Criteria (CTC) Grade greater than 1. History of significant neurological or mental disorder, including seizures or dementia

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, Gemzar2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles	Drug	Gemcitabine + Carboplatin, Gemcitabine + Cisplatin, Gemcitabine + Paclitaxel
paclitaxel150 mg/m2, IV, every 14 days x 8 cycles	Drug	Gemcitabine + Paclitaxel
carboplatinArea Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles	Drug	Gemcitabine + Carboplatin
cisplatin50 mg/m2, IV, every 14 days x 8 cycles	Drug	Gemcitabine + Cisplatin

Primary outcome

Best Overall Response
Time frame: baseline to measured progressive disease (tumor assessments were performed every 4 cycles during study therapy, or 3 months during post-therapy until disease progression, death or up to 24 months after randomization)
Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.

4 secondary outcomes

Number of Participants With a Time to Treatment Failure (TTTF) Event
Time frame: randomization to date of documented disease progression, death on study, start of non-protocol-specified anticancer therapy, or therapy discontinuation due to toxicity, whichever occurred first (up to 6 months)
Progression Free Survival (PFS)
Time frame: baseline to measured progressive disease or death (tumor assessments were performed every 4 cycles during study therapy, or 3 months during post-therapy until disease progression, death, or up to 24 months after randomization)
Duration of Response
Time frame: time of response to progressive disease or death (tumor assessments were performed every 4 cycles during study therapy, or 3 months during post-therapy until disease progression, death, or up to 24 months after randomization)
Overall Survival
Time frame: baseline to date of death from any cause (up to 34 months)

Results and safety

Results posted to the registry on 31 Aug 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
Gemcitabine + Paclitaxel	49	12
Gemcitabine + Carboplatin	47	17
Gemcitabine + Cisplatin	51	12

Primary outcome: Best Overall Response

Time frame: baseline to measured progressive disease (tumor assessments were performed every 4 cycles during study therapy, or 3 months during post-therapy until disease progression, death or up to 24 months after randomization). Number. Unit: participants

Measure	Gemcitabine + Paclitaxel n = 49	Gemcitabine + Carboplatin n = 47	Gemcitabine + Cisplatin n = 51
Complete Response (CR)	1	0	1
Partial Response (PR)	12	8	7
Stable Disease (SD)	17	25	29
Progressive Disease (PD)	14	11	11
Early Death from Other Causes	1	2	0
Unknown	4	1	3

Population analysed: Number of all randomized participants.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Gemcitabine + Paclitaxel	5 of 49 (10.2%)	48 of 49 (98%)	Not reported
Gemcitabine + Carboplatin	3 of 47 (6.4%)	46 of 47 (97.9%)	Not reported
Gemcitabine + Cisplatin	0 of 50 (0%)	50 of 50 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Lilly Clinical Trial RegistryLink provided by the sponsor.

Related trials for Breast Cancer

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Not yet recruitingObservational study
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Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

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 Monday-Friday 9:00 AM to 5:00 PM Est Time (UTC/GMT - 5 hours) study director

Eli Lilly and Company

18 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing gemcitabine, paclitaxel and carboplatin in people with Breast Cancer, run by Eli Lilly and Company at 18 sites in 6 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: finished, as of the sponsor's last update on 2 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 18 sites in India, China, Mexico, Turkey (Türkiye), Brazil and 1 more country. 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 31 Aug 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 Response (time frame: baseline to measured progressive disease (tumor assessments were performed every 4 cycles during study therapy, or 3 months during post-therapy until disease progression, death or up to 24 months after randomization)). 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 NCT00191854.

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 2 Mar 2010.