Metastatic Breast Cancer (MBC)Phase 3NCT00236899

Phase III Study of Two Different Schedules (Weekly and Tri-weekly) of Combination of Gemcitabine and Two Taxanes in MBC

A Phase 3 study testing Gemcitabine, Docetaxel and Paclitaxel in people with Metastatic Breast Cancer (MBC), run by Eli Lilly and Company at 34 sites in Italy.

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

Multi-center, randomized Phase III study. 4 arms. 360 Patient to enroll. Purpose is evaluate time to progression disease (PD). Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Metastatic Breast Cancer (MBC)
What is being tested?: Gemcitabine, Docetaxel and Paclitaxel
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 241 participants
Where: 34 sitesItaly
Study dates: Sep 2005to Aug 2010
Phase: Phase 3
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

Histologic diagnosis of metastatic breast cancer (MBC).
Prior neoadjuvant or adjuvant taxanes regimen is allowed if ≥12 months since completion of the regimen.
Relapsing after receiving one adjuvant/neoadjuvant chemotherapy containing an anthracycline if not clinically contraindicated.
Patients with measurable disease.
Previous hormonal therapy for adjuvant setting or metastatic disease.

Who cannot join

Previous chemotherapy for MBC
Previous chemotherapy with gemcitabine in any setting of disease
Patient candidable to treatment with trastuzumab.

Trial locations and contacts

34 sites in 1 country.

City, postcode or hospital

34 sites in 1 country

Italy34 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.
Avellino, 50019
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Bologna, 40100
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Brescia, 25124
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Cagliari, 09042
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Candiolo-Torino, 10060
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Casale Monferrato, 15033
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Castelfranco Veneto, 31033
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Catania, 95126
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Cuneo, 12100
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Ferrara, 44100
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Frosinone, 03100
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Genova, 16132
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Gorgonzola, 20064
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Lecce, 73100
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Mantua, 46100
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Milan, 20162
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Naples, 80131
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Negrar, 37024
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Padova, 35128
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Parma, 43100
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Piacenza, 29100
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Pisa, 56100
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Potenza, 85028
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Reggio Calabria, 89100
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Rome, 00161
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San Sisto, 06156
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Sassari, 07100
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Taormina, 98039
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Torino, 10126
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Trento, 38100
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Treviglio, 24047
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Trieste, 34142
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Udine, 33100
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Viterbo, 01100

Other trials in Italy

About this study

Official title: A Randomized Phase III Trial of Gemcitabine and Docetaxel Versus Gemcitabine and Paclitaxel in Patients With Metastatic Breast Cancer: A Comparison of Different Schedules

Multi-center, randomized Phase III study. 4 arms. 360 Patient to enroll. Purpose is evaluate time to progression disease (PD).

Conditions: Metastatic Breast Cancer (MBC)
Being tested: Gemcitabine, Docetaxel, 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
Arm A: 1000 mg/m², 30 minute (min) intravenous (IV) infusion on Days 1 and 8, repeated every 21 days for 10 cycles for complete responders (CRs=disappearance of all target lesions) or partial responders (PRs≥30% decrease in sum of longest diameter of target lesions); 6 cycles for stable disease (SD=small changes that do not meet the above criteria); or until progressive disease (PD≥20% increase in sum of longest diameter of target lesions).
Arm B: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Arm C: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Arm D: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
DocetaxelDrug
Arm A: 75 milligram per square meter (mg/m²), 60 min IV infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Arm C: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15, to be given 30 min prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
PaclitaxelDrug
Arm B: 175 mg/m², IV infusion over approximately 3 hours, followed by Gemcitabine, on Day 1, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Arm D: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.

Study groups in NCT00236899
Study group	Role	What they receive
A: Docetaxel and Gemcitabine (Tri-weekly)	Experimental	Docetaxel and Gemcitabine (Tri-weekly) Receives: Drug: Gemcitabine; Drug: Docetaxel
B: Paclitaxel and Gemcitabine (Tri-weekly)	Experimental	Paclitaxel and Gemcitabine (Tri-weekly) Receives: Drug: Gemcitabine; Drug: Paclitaxel
C: Docetaxel and Gemcitabine (Weekly)	Experimental	Docetaxel and Gemcitabine (Weekly) Receives: Drug: Gemcitabine; Drug: Docetaxel
D: Paclitaxel and Gemcitabine (Weekly)	Experimental	Paclitaxel and Gemcitabine (Weekly) Receives: Drug: Gemcitabine; Drug: Paclitaxel

What is being measured

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

Time to Progressive Disease (TTPD) by Treatment Schedule
TTPD is defined as the time from the day of treatment to first observation of documented disease progression or death due to any cause, whichever comes first. TTPD was censored at the time of last follow-up for patients who were still alive without progression. Tumor response was assessed in cancer patients by using Response Evaluation Criteria in Solid Tumors (RECIST), which define when cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. Progressive Disease is a ≥20% increase in sum of longest diameter of target lesions.
Measured: Baseline up to 49.84 months
Time to Progressive Disease (TTPD) by Treatment Drug
TTPD is defined as the time from the day of treatment to first observation of documented disease progression or death due to any cause, whichever comes first. TTPD was censored at the time of last follow-up for patients who were still alive without progression. Tumor response was assessed in cancer patients by using Response Evaluation Criteria in Solid Tumors (RECIST), which define when cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. Progressive Disease is a ≥20% increase in sum of longest diameter of target lesions.
Measured: Baseline up to 49.84 months

Secondary outcomes (7)

Overall Survival (OS) by Treatment Schedule
OS is the duration from enrollment to time of death as a result of any cause. For participants who are alive, OS is censored at the last contact (date of the last follow-up visit).
Measured: Baseline up to 51.64 months
Overall Survival (OS) by Treatment Drug
OS is the duration from enrollment to time of death as a result of any cause. For participants who are alive, OS is censored at the last contact (date of the last follow-up visit).
Measured: Baseline up to 51.64 months
Overall Response Rate (ORR) by Treatment Schedule
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. Not Available=participants assessed whose data were not available. Not Assessed=participants who did not participate in assessments. The ORR=sum of complete and partial tumor responses observed, divided by the total number of evaluable participants.
Measured: Baseline up to 49.84 months
Overall Response Rate(ORR) by Treatment Drug
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. Not Available=participants assessed whose data were not available. Not Assessed=participants who did not participate in assessments. The ORR=sum of complete and partial tumor responses observed, divided by the total number of evaluable participants.
Measured: Baseline up to 49.84 months
Number of Participants With Serious and Nonserious Adverse Events (AEs)
Summary tables of serious adverse events (SAEs) and all other nonserious AEs are located in the Reported Adverse Event Module.
Measured: Baseline up to 51.64 months
Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at Beginning of 3-Week or 4-Week Cycle
RSSC is a valid and reliable measure of psychological and physical distress of cancer patients. Overall QOL is assessed on a 7-point scale (1=Excellent to 7=Extremely Poor). Categories include Excellent, Good, Moderately Good, Neither Good nor Bad, Rather Poor, Poor, and Extremely Poor. Number of responses to the overall QOL by treatment arm are provided. Arms A (Docetaxel and Gemcitabine 3 Weekly) and B (Paclitaxel and Gemcitabine 3 Weekly) were assessed every 3 weeks. Arms C (Docetaxel and Gemcitabine Weekly) and D (Paclitaxel and Gemcitabine Weekly) were assessed every 4 weeks.
Measured: Baseline up to 51.64 months
Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at 30-Day Post-therapy Visit
RSSC is a valid and reliable measure of psychological and physical distress of cancer patients. Overall QOL is assessed on a 7-point scale (1=Excellent to 7=Extremely Poor). Categories include Excellent, Good, Moderately Good, Neither Good nor Bad, Rather Poor, Poor, and Extremely Poor. Number of responses to the overall QOL (using the 7-point scale) by treatment arm are provided.
Measured: Baseline up to 51.64 months

Timeline

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

Sep 2005Aug 2010

First posted12 Oct 2005 (estimated)
Study startSep 2005
Primary completionAug 2010
Study completionAug 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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Metastatic Breast Cancer (MBC)Studies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Enrolment: 241 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00236899
Sponsor's protocol ID: 9846
Other IDs: B9E-IT-S376
Status last verified: Aug 2011
First submitted: 7 Oct 2005
Last updated: 27 Sep 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Del Mastro L, Fabi A, Mansutti M, De Laurentiis M, Durando A, Merlo DF, Bruzzi P, La Torre I, Ceccarelli M, Kazeem G, Marchi P, Boy D, Venturini M, De Placido S, Cognetti F. Randomised phase 3 open-label trial of first-line treatment with gemcitabine in association with docetaxel or paclitaxel in women with metastatic breast cancer: a comparison of different schedules and treatments. BMC Cancer. 2013 Mar 28;13:164. doi: 10.1186/1471-2407-13-164.
PubMed 23537313

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?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Phase III Trial of Gemcitabine and Docetaxel Versus Gemcitabine and Paclitaxel in Patients With Metastatic Breast Cancer: A Comparison of Different Schedules
ClinicalTrials.gov ID: NCT00236899
Acronym / sponsor ID: 9846
Conditions: Metastatic Breast Cancer (MBC)
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 241 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Sep 2005
Primary completion: Aug 2010 (actual)
Study completion: Aug 2010 (actual)
First posted: 12 Oct 2005 (estimated)
Results: Posted 27 Sep 2011

Clinical summary

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

Multi-center, randomized Phase III study. 4 arms. 360 Patient to enroll. Purpose is evaluate time to progression disease (PD).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
A: Docetaxel and Gemcitabine (Tri-weekly)	Experimental	Drug: Gemcitabine, Drug: DocetaxelDocetaxel and Gemcitabine (Tri-weekly)
B: Paclitaxel and Gemcitabine (Tri-weekly)	Experimental	Drug: Gemcitabine, Drug: PaclitaxelPaclitaxel and Gemcitabine (Tri-weekly)
C: Docetaxel and Gemcitabine (Weekly)	Experimental	Drug: Gemcitabine, Drug: DocetaxelDocetaxel and Gemcitabine (Weekly)
D: Paclitaxel and Gemcitabine (Weekly)	Experimental	Drug: Gemcitabine, Drug: PaclitaxelPaclitaxel and Gemcitabine (Weekly)

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)

Histologic diagnosis of metastatic breast cancer (MBC).
Prior neoadjuvant or adjuvant taxanes regimen is allowed if ≥12 months since completion of the regimen.
Relapsing after receiving one adjuvant/neoadjuvant chemotherapy containing an anthracycline if not clinically contraindicated.
Patients with measurable disease.
Previous hormonal therapy for adjuvant setting or metastatic disease.

Key exclusion criteria (3 listed)

Previous chemotherapy for MBC
Previous chemotherapy with gemcitabine in any setting of disease
Patient candidable to treatment with trastuzumab.

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, GemzarArm A: 1000 mg/m², 30 minute (min) intravenous (IV) infusion on Days 1 and 8, repeated every 21 days for 10 cycles for complete responders (CRs=disappearance of all target lesions) or partial responders (PRs≥30% decrease in sum of longest diameter of target lesions); 6 cycles for stable disease (SD=small changes that do not meet the above criteria); or until progressive disease (PD≥20% increase in sum of longest diameter of target lesions). Arm B: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD. Arm C: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD. Arm D: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.	Drug	A: Docetaxel and Gemcitabine (Tri-weekly), B: Paclitaxel and Gemcitabine (Tri-weekly), C: Docetaxel and Gemcitabine (Weekly), D: Paclitaxel and Gemcitabine (Weekly)
DocetaxelArm A: 75 milligram per square meter (mg/m²), 60 min IV infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD. Arm C: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15, to be given 30 min prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.	Drug	A: Docetaxel and Gemcitabine (Tri-weekly), C: Docetaxel and Gemcitabine (Weekly)
PaclitaxelArm B: 175 mg/m², IV infusion over approximately 3 hours, followed by Gemcitabine, on Day 1, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD. Arm D: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.	Drug	B: Paclitaxel and Gemcitabine (Tri-weekly), D: Paclitaxel and Gemcitabine (Weekly)

Primary outcome

Time to Progressive Disease (TTPD) by Treatment Schedule
Time frame: Baseline up to 49.84 months
TTPD is defined as the time from the day of treatment to first observation of documented disease progression or death due to any cause, whichever comes first. TTPD was censored at the time of last follow-up for patients who were still alive without progression. Tumor response was assessed in cancer patients by using Response Evaluation Criteria in Solid Tumors (RECIST), which define when cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. Progressive Disease is a ≥20% increase in sum of longest diameter of target lesions.
Time to Progressive Disease (TTPD) by Treatment Drug
Time frame: Baseline up to 49.84 months
TTPD is defined as the time from the day of treatment to first observation of documented disease progression or death due to any cause, whichever comes first. TTPD was censored at the time of last follow-up for patients who were still alive without progression. Tumor response was assessed in cancer patients by using Response Evaluation Criteria in Solid Tumors (RECIST), which define when cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. Progressive Disease is a ≥20% increase in sum of longest diameter of target lesions.

7 secondary outcomes

Overall Survival (OS) by Treatment Schedule
Time frame: Baseline up to 51.64 months
Overall Survival (OS) by Treatment Drug
Time frame: Baseline up to 51.64 months
Overall Response Rate (ORR) by Treatment Schedule
Time frame: Baseline up to 49.84 months
Overall Response Rate(ORR) by Treatment Drug
Time frame: Baseline up to 49.84 months
Number of Participants With Serious and Nonserious Adverse Events (AEs)
Time frame: Baseline up to 51.64 months
Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at Beginning of 3-Week or 4-Week Cycle
Time frame: Baseline up to 51.64 months
Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at 30-Day Post-therapy Visit
Time frame: Baseline up to 51.64 months

Results and safety

Results posted to the registry on 27 Sep 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm A: Docetaxel and Gemcitabine (Tri-weekly)	60	18
Arm B: Paclitaxel and Gemcitabine (Tri-weekly)	64	24
Arm C: Docetaxel and Gemcitabine (Weekly)	58	14
Arm D: Paclitaxel and Gemcitabine (Weekly)	59	19

Primary outcome: Time to Progressive Disease (TTPD) by Treatment Schedule

Time frame: Baseline up to 49.84 months. Median (95% Confidence Interval). Unit: months

Measure	Treatment Schedule (Weekly) n = 117	Treatment Schedule (3 Weekly) n = 124
Value	8.33 (6.19 to 10.16)	7.51 (5.93 to 8.33)

Treatment Schedule (Weekly) vs Treatment Schedule (3 Weekly): Hazard Ratio (HR): 1.14 (95% CI 0.87 to 1.50), p = 0.345, Regression, Cox

Population analysed: Intention to treat (ITT) population is defined as the population of all randomized participants. Treatment arms based on treatment schedule (Weekly vs 3 Weekly) were combined for this population. A total of 33 participants were censored with 16 (13.68%)in the Weekly arm and 17 (13.71%) participants in the 3 Weekly arm.

Primary outcome: Time to Progressive Disease (TTPD) by Treatment Drug

Time frame: Baseline up to 49.84 months. Median (95% Confidence Interval). Unit: months

Measure	Treatment Drug (Docetaxel) n = 118	Treatment Drug (Paclitaxel) n = 123
Value	7.74 (5.57 to 9.80)	7.80 (6.20 to 8.72)

Treatment Drug (Docetaxel) vs Treatment Drug (Paclitaxel): Hazard Ratio (HR): 1.23 (95% CI 0.93 to 1.62), p = 0.150, Regression, Cox

Population analysed: ITT population defined as the population of all randomized participants. Treatment arms based on Treatment Drug (Docetaxel+Gemcitabine vs Paclitaxel+Gemcitabine) were combined for this population. A total of 33 (13.7%) participants were censored with 17 (13.68%) in the Docetaxel+Gemcitabine arm and 18 (13.71%) in the Paclitaxel+Gemcitabine arm.

7 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
Arm A: Docetaxel and Gemcitabine (Tri-weekly)	9 of 59 (15.3%)	57 of 59 (96.6%)	Not reported
Arm B: Paclitaxel and Gemcitabine (Tri-weekly)	10 of 62 (16.1%)	58 of 62 (93.5%)	Not reported
Arm C: Docetaxel and Gemcitabine (Weekly)	7 of 58 (12.1%)	53 of 58 (91.4%)	Not reported
Arm D: Paclitaxel and Gemcitabine (Weekly)	11 of 59 (18.6%)	56 of 59 (94.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23537313Del Mastro L, Fabi A, Mansutti M, De Laurentiis M, Durando A, Merlo DF, Bruzzi P, La Torre I, Ceccarelli M, Kazeem G, Marchi P, Boy D, Venturini M, De Placido S, Cognetti F. Randomised phase 3 open-label trial of first-line treatment with gemcitabine in association with docetaxel or paclitaxel in women with metastatic breast cancer: a comparison of different schedules and treatments. BMC Cancer. 2013 Mar 28;13:164. doi: 10.1186/1471-2407-13-164.
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 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST) study chair

Eli Lilly and Company

34 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Gemcitabine, Docetaxel and Paclitaxel in people with Metastatic Breast Cancer (MBC), run by Eli Lilly and Company at 34 sites in Italy.

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 3 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 27 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in Italy. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 27 Sep 2011). 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?

Time to Progressive Disease (TTPD) by Treatment Schedule (time frame: Baseline up to 49.84 months). The study lists 2 primary outcomes in all. 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 NCT00236899, 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 27 Sep 2011.