Breast CancerPhase 3NCT00191152
A Phase III Trial For Patients With Metastatic Breast Cancer
A Phase 3 study testing gemcitabine, docetaxel and capecitabine in people with Breast Cancer and Breast Neoplasms, run by Eli Lilly and Company at 65 sites in 8 countries.
Trial summary
This is a phase III randomized study between the docetaxel/gemcitabine and docetaxel/ capecitabine doublets, with crossover to the alternate agent. The experimental arm will receive gemcitabine 1000 mg/m2 intravenous (IV) over 30 minutes days 1 and 8 and docetaxel 75 mg/m2 IV day 1 over 1 hour repeated every three… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Breast Neoplasms, Cancer of the Breast
- What is being tested?
- gemcitabine, docetaxel and capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 475 participants
- Where
- 65 sitesin 8 countries
- Study dates
- Feb 2002to Nov 2008
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic or cytologic confirmation of breast cancer with locally advanced and/or metastatic disease
- Patients may have received prior neo-adjuvant or adjuvant taxane regimen as long as it has been greater than or equal to 6 months since completion of the regimen
- Patients may have had 0-1, but no more than one prior course of chemotherapy for metastatic disease
- Patients must have either measurable or non-measurable (evaluable) disease
- Prior radiation therapy allowed of less than 25% of the bone marrow
Who cannot join
- Second primary malignancy (except in situ carcinoma of the cervix or adequately treated nonmelanomatous carcinoma of the skin or other malignancy treated at least 5 years previously with no evidence of recurrence)
- Parenchymal or leptomeningeal brain metastases
- Peripheral neuropathy greater than or equal to grade 2
- Prior treatment with gemcitabine and capecitabine will not be allowed. Prior treatment with a taxane in the metastatic setting will not be allowed. Prior taxane therapy in the neo-adjuvant or adjuvant setting is allowed if completion of therapy greater than or equal to 6 months prior to enrollment.
- Active cardiac disease not controlled by therapy and/or myocardial infarction within the preceding 6 months.
- Concomitant Herceptin is not allowed
Trial locations and contacts
65 sites in 8 countries.
65 sites in 8 countries
United States47 sites
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Austin, Texas
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Berkeley, California
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Charleston, South Carolina
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Columbia, Missouri
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Dallas, Texas
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Denver, Colorado
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Dunmore, Pennsylvania
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Fort Myers, Florida
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Fort Smith, Arkansas
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Fountain Valley, California
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Franklin, Pennsylvania
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Fremont, Nebraska
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Glendale, Arizona
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Highland, California
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Hollywood, Florida
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Hot Springs, Arkansas
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Idaho Falls, Idaho
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Iowa City, Iowa
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Johnstown, Pennsylvania
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Kittanning, Pennsylvania
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Knoxville, Tennessee
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La Jolla, California
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Little Rock, Arkansas
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Los Angeles, California
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Louisville, Kentucky
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Lubbock, Texas
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Madison, Wisconsin
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Memphis, Tennessee
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Metairie, Louisiana
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Milwaukee, Wisconsin
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Nashville, Tennessee
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New York, New York
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Orlando, Florida
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Pittsburgh, Pennsylvania
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Rancho Mirage, California
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Royal Oak, Michigan
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San Antonio, Texas
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San Diego, California
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Santa Rosa, California
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South Bend, Indiana
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Southfield, Michigan
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Springdale, Arkansas
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Springfield, Ohio
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St Louis, Missouri
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Sylmar, California
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Torrington, Connecticut
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Voorhees Township, New Jersey
Argentina4 sites
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Capital Federal
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Mendoza
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Rosario
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Santa Fe
Mexico4 sites
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Acapulco
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Mexico City
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Michoacán
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Toluca
Taiwan4 sites
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Kaohsiung City
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Taichung
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Taipei
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Taoyuan
Australia3 sites
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Ashford, South Australia
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Redcliffe, Queensland
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Waratah, New South Wales
Brazil1 site
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Porto Alegre
Puerto Rico1 site
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San Juan
South Korea1 site
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Seoul
About this study
Official title: Randomized Trial of Gemcitabine Plus Docetaxel vs. Docetaxel Plus Capecitabine in Metastatic Breast Cancer in 1st and 2nd
This is a phase III randomized study between the docetaxel/gemcitabine and docetaxel/ capecitabine doublets, with crossover to the alternate agent. The experimental arm will receive gemcitabine 1000 mg/m2 intravenous (IV) over 30 minutes days 1 and 8 and docetaxel 75 mg/m2 IV day 1 over 1 hour repeated every three weeks. The comparator arm will receive docetaxel 75 mgm/m2 IV day 1 over 1 hour and oral capecitabine 1000 mg/m2 twice daily, days 1 through 14 repeated every three weeks. Patients who progress on the experimental arm, will be treated with capecitabine as dosed on the comparator arm. Patients who progress on the comparator arm will be treated with gemcitabine as dosed on the experimental arm.
- Conditions
- Breast Cancer, Breast Neoplasms, Cancer of the Breast
- Being tested
- gemcitabine, docetaxel, capecitabine
- 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
1000 mg/m2, intravenous (IV) day 1 and day 8 every 21 days until disease progression
docetaxelDrug
75 mg/m2, intravenous (IV), every 21 days until disease progression
capecitabineDrug
1000 mg/m2, by mouth (PO) twice a day (BID), days 1-14, every 21 days until disease progression
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine + Docetaxel | Experimental | Not described Receives: Drug: gemcitabine; Drug: docetaxel |
| Capecitabine + Docetaxel | Active comparator | Not described Receives: Drug: docetaxel; Drug: capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Disease Progression (Initial Treatment)
Time to disease progression (TTDP) at initial treatment was defined as the number of months between date of randomization and the date of first documented disease progression or the date of death due to disease under study, whichever came first. TTDP censored at earliest of: 1) date of death not due to disease; or 2) date of last contact for participants alive without disease progression; or 3) start date of other anti-tumor therapy; or 4) first dose date of crossover treatment.
Measured: Randomization date to the earliest date of first documented disease progression date or the date of death if the participant died due to study disease (up to 82 months)
Secondary outcomes (12)
Time to Disease Progression (Crossover Treatment)
For crossover treatment, time to disease progression (TTDP) was defined as the number of months between the first dose date of crossover treatment and the date of disease progression or the date of death due to disease under study, whichever came first. TTDP for crossover treatment only applied to those participants who crossed over from initial treatment to crossover treatment. TTDP censored at earliest of: 1)date of death not due to disease; or 2)date of last contact for participants alive without disease progression; or 3)start date of other anti-tumor therapy due to progression.
Measured: Date of first dose of crossover treatment to date of first-documented disease progression after receiving first crossover treatment or date of death due to study disease, whichever came first (up to 82 months)
Progression-Free Survival (Initial Treatment)
For initial treatment, progression-free survival (PFS) was defined as the number of months between the date of randomization and the date of first documented disease progression or the date of death due to any cause, whichever came first. Time to PFS was censored at the earliest of: 1) date of last contact for participants alive without disease progression; or 2) start date of other anti-tumor therapy for progression; or 3) first dose date of crossover treatment.
Measured: Date of randomization until the date of first documented progression or date of death from any cause, whichever came first (up to 82 months)
Progression-Free Survival (Crossover Treatment)
For crossover treatment, progression-free survival (PFS) was defined as the number of months between first dose date of crossover treatment and date of documented disease progression or date of death due to any cause, whichever came first. PFS for crossover treatment only applied to those participants who crossed over from initial treatment to crossover treatment. PFS was censored at the earliest of: 1) date of last contact for participants alive without disease progression; or 2) start date of other anti-tumor therapy for participants with documented disease progression.
Measured: First dose date of crossover treatment to date of first-documented progression after receiving crossover treatment or date of death due to any cause, whichever came first (up to 82 months)
Duration of Response (Initial Treatment)
Among tumor responders, duration of tumor response was measured from the date of response (complete response [CR] or partial response [PR] until the first date of documented progression or death from any cause. Duration of response was censored at the earliest of: 1) date of last contact for participants alive without disease progression (DP); or 2) start date of other anti-tumor therapy for DP; or 3) dose date of crossover treatment.
Measured: Date of response (CR or PR) until the first date of documented progression or death from any cause (up to 82 months)
Duration of Response (Crossover Treatment)
At crossover treatment, duration of response was measured from the time criteria were met for complete response (CR) or partial response (PR), until first date that recurrent or progressive disease was objectively documented or date of death due to any cause, whichever came first. This definition only applied to those who crossed over \& achieved CR or PR in crossover treatment. Duration of response censored at earliest of: 1) date of last contact for those alive without disease progression; or 2) start date of other anti-tumor therapy for documented disease progression.
Measured: Date of CR or PR until first date of recurrent or progressive disease after receiving crossover treatment was objectively documented or date of date due to any cause, whichever came first (up to 82 months)
Overall Survival
Overall survival time was defined as the number of months between the date of randomization and the date of death due to any cause. The overall survival time was censored at the date of last contact for participants who were still alive.
Measured: Date of randomization to date of death from any cause (up to 82 months)
Best Overall Response (Initial Treatment)
Best overall response was the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Response was assessed 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 did not meet above criteria.
Measured: Best response from start of treatment until disease progression/recurrence (up to 82 months)
Best Overall Response (Crossover Treatment)
Best overall response was the best response recorded from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Response assessed using 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 did not meet above criteria.
Measured: Best response from start of treatment until disease progression/recurrence (up to 82 months)
Summary of Changes in Karnofsky Performance Status (KPS) by Treatment (Initial Treatment)
KPS ranges from 0 to 100, subdivided into three categories: incapacitated (0-40), self-care (50-70), and normal activity (80-100).
Measured: Baseline until crossover treatment began (up to 82 months)
Summary of Changes in Karnofsky Performance Status (KPS) by Treatment (Crossover Treatment)
KPS ranges from 0 to 100, subdivided into three categories: incapacitated (0-40), self-care (50-70), and normal activity (80-100).
Measured: First day of crossover treatment until end of crossover treatment at trial discontinuation (up to 82 moths)
Summary of Changes in Rotterdam Symptom Checklist (RSCL) by Treatment (Initial Treatment)
RSCL includes 4 scales to assess quality of life (QOL) endpoints: 1) a 23-item physical distress level with scale score ranges from 23 to 92 [low score represents better QOL] 2)a 7-item psychological distress level with scale score ranges from 7 to 28[low score represents better QOL] 3)8-item activity level with scale score ranges from 8 to 32 [high score represents better QOL]; 1-item overall valuation of life with score range from 1 to 7 [low score represents better QOL].
Measured: Baseline until crossover treatment began (up to 82 months)
Summary of Changes in Rotterdam Symptom Checklist by Treatment (Crossover Treatment)
RSCL includes 4 scales to assess quality of life (QOL) endpoints: 1) a 23-item physical distress level with scale score ranges from 23 to 92 [low score represents better QOL] 2)a 7-item psychological distress level with scale score ranges from 7 to 28[low score represents better QOL] 3)8-item activity level with scale score ranges from 8 to 32 [high score represents better QOL]; 1-item overall valuation of life with score range from 1 to 7 [low score represents better QOL].
Measured: First day of crossover treatment until end of crossover treatment at trial discontinuation (up to 82 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startFeb 2002
- Primary completionNov 2008
- Study completionNov 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 475 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
- NCT00191152
- Sponsor's protocol ID
- 4703
- Other IDs
- B9E-US-S188
- Status last verified
- Dec 2009
- First submitted
- 12 Sep 2005
- Last updated
- 24 Dec 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.
PubMed 34037241
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Gemcitabine Plus Docetaxel vs. Docetaxel Plus Capecitabine in Metastatic Breast Cancer in 1st and 2nd
- ClinicalTrials.gov ID
- NCT00191152
- Acronym / sponsor ID
- 4703
- Conditions
- Breast Cancer, Breast Neoplasms, Cancer of the Breast
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 475 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Feb 2002
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Posted 8 Dec 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase III randomized study between the docetaxel/gemcitabine and docetaxel/ capecitabine doublets, with crossover to the alternate agent. The experimental arm will receive gemcitabine 1000 mg/m2 intravenous (IV) over 30 minutes days 1 and 8 and docetaxel 75 mg/m2 IV day 1 over 1 hour repeated every three weeks. The comparator arm will receive docetaxel 75 mgm/m2 IV day 1 over 1 hour and oral capecitabine 1000 mg/m2 twice daily, days 1 through 14 repeated every three weeks. Patients who progress on the experimental arm, will be treated with capecitabine as dosed on the comparator arm. Patients who progress on the comparator arm will be treated with gemcitabine as dosed on the experimental arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine + Docetaxel | Experimental | Drug: gemcitabine, Drug: docetaxel |
| Capecitabine + Docetaxel | Active comparator | Drug: docetaxel, Drug: capecitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologic or cytologic confirmation of breast cancer with locally advanced and/or metastatic disease
- Patients may have received prior neo-adjuvant or adjuvant taxane regimen as long as it has been greater than or equal to 6 months since completion of the regimen
- Patients may have had 0-1, but no more than one prior course of chemotherapy for metastatic disease
- Patients must have either measurable or non-measurable (evaluable) disease
- Prior radiation therapy allowed of less than 25% of the bone marrow
Key exclusion criteria (6 listed)
- Second primary malignancy (except in situ carcinoma of the cervix or adequately treated nonmelanomatous carcinoma of the skin or other malignancy treated at least 5 years previously with no evidence of recurrence)
- Parenchymal or leptomeningeal brain metastases
- Peripheral neuropathy greater than or equal to grade 2
- Prior treatment with gemcitabine and capecitabine will not be allowed. Prior treatment with a taxane in the metastatic setting will not be allowed. Prior taxane therapy in the neo-adjuvant or adjuvant setting is allowed if completion of therapy greater than or equal to 6 months prior to enrollment.
- Active cardiac disease not controlled by therapy and/or myocardial infarction within the preceding 6 months.
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, Gemzar1000 mg/m2, intravenous (IV) day 1 and day 8 every 21 days until disease progression | Drug | Gemcitabine + Docetaxel |
| docetaxel75 mg/m2, intravenous (IV), every 21 days until disease progression | Drug | Capecitabine + Docetaxel, Gemcitabine + Docetaxel |
| capecitabine1000 mg/m2, by mouth (PO) twice a day (BID), days 1-14, every 21 days until disease progression | Drug | Capecitabine + Docetaxel |
Primary outcome
Time to Disease Progression (Initial Treatment)
Time frame: Randomization date to the earliest date of first documented disease progression date or the date of death if the participant died due to study disease (up to 82 months)
Time to disease progression (TTDP) at initial treatment was defined as the number of months between date of randomization and the date of first documented disease progression or the date of death due to disease under study, whichever came first. TTDP censored at earliest of: 1) date of death not due to disease; or 2) date of last contact for participants alive without disease progression; or 3) start date of other anti-tumor therapy; or 4) first dose date of crossover treatment.
12 secondary outcomes
Time to Disease Progression (Crossover Treatment)
Time frame: Date of first dose of crossover treatment to date of first-documented disease progression after receiving first crossover treatment or date of death due to study disease, whichever came first (up to 82 months)
Progression-Free Survival (Initial Treatment)
Time frame: Date of randomization until the date of first documented progression or date of death from any cause, whichever came first (up to 82 months)
Progression-Free Survival (Crossover Treatment)
Time frame: First dose date of crossover treatment to date of first-documented progression after receiving crossover treatment or date of death due to any cause, whichever came first (up to 82 months)
Duration of Response (Initial Treatment)
Time frame: Date of response (CR or PR) until the first date of documented progression or death from any cause (up to 82 months)
Duration of Response (Crossover Treatment)
Time frame: Date of CR or PR until first date of recurrent or progressive disease after receiving crossover treatment was objectively documented or date of date due to any cause, whichever came first (up to 82 months)
Overall Survival
Time frame: Date of randomization to date of death from any cause (up to 82 months)
Best Overall Response (Initial Treatment)
Time frame: Best response from start of treatment until disease progression/recurrence (up to 82 months)
Best Overall Response (Crossover Treatment)
Time frame: Best response from start of treatment until disease progression/recurrence (up to 82 months)
Summary of Changes in Karnofsky Performance Status (KPS) by Treatment (Initial Treatment)
Time frame: Baseline until crossover treatment began (up to 82 months)
Summary of Changes in Karnofsky Performance Status (KPS) by Treatment (Crossover Treatment)
Time frame: First day of crossover treatment until end of crossover treatment at trial discontinuation (up to 82 moths)
Summary of Changes in Rotterdam Symptom Checklist (RSCL) by Treatment (Initial Treatment)
Time frame: Baseline until crossover treatment began (up to 82 months)
Summary of Changes in Rotterdam Symptom Checklist by Treatment (Crossover Treatment)
Time frame: First day of crossover treatment until end of crossover treatment at trial discontinuation (up to 82 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34037241Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.
- 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
65 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing gemcitabine, docetaxel and capecitabine in people with Breast Cancer and Breast Neoplasms, run by Eli Lilly and Company at 65 sites in 8 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 6 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 24 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 65 sites in United States, Argentina, Mexico, Taiwan, Australia and 3 more countries. 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 8 Dec 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?
Time to Disease Progression (Initial Treatment) (time frame: Randomization date to the earliest date of first documented disease progression date or the date of death if the participant died due to study disease (up to 82 months)). 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 NCT00191152, 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 24 Dec 2009.