Breast CancerPhase 2NCT00077857
A Study to Assess Capecitabine (Xeloda®) in Patients With Locally Advanced or Metastatic Breast Cancer
A Phase 2 study testing capecitabine (Xeloda®) and docetaxel (Taxotere®) in people with Breast Cancer, run by Hoffmann-La Roche at 94 sites in 9 countries.
Trial summary
This 2 arm study compared the efficacy and safety of label dose of capecitabine (Xeloda®) to that of a lower dose of Xeloda® plus docetaxel (Taxotere®) in patients with locally advanced or metastatic breast cancer after failure of chemotherapy with an anthracycline. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- capecitabine (Xeloda®) and docetaxel (Taxotere®)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 470 participants
- Where
- 94 sitesin 9 countries
- Study dates
- Jul 2003to 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women >=18 years of age;
- >=1 target lesion;
- locally advanced or metastatic breast cancer;
- demonstrated resistance to anthracycline;
- >=2 regimens of chemotherapy for advanced/metastatic disease.
Who cannot join
- previous treatment with Xeloda, continuous 5-fluorouracil infusion, or other oral fluoropyrimidines;
- previous treatment with paclitaxel or docetaxel for advanced/metastatic disease.
Trial locations and contacts
94 sites in 9 countries.
94 sites in 9 countries
United States43 sites
Study site
Abingdon, Virginia, 24211
Study site
Allentown, Pennsylvania, 18104
Study site
Austin, Texas, 78705
Study site
Baltimore, Maryland, 21202
Study site
Baltimore, Maryland, 21236
Study site
Beech Grove, Indiana, 46107
Study site
Berkeley, California, 94704
Study site
Birmingham, Alabama, 35233
Study site
Boca Raton, Florida, 33486
Study site
Boston, Massachusetts, 02118
Study site
Canton, Ohio, 44718
Study site
Charleston, South Carolina, 29406
Study site
Colchester, Vermont, 05446
Study site
Collierville, Tennessee, 38017
Study site
Columbia, South Carolina, 29203
Study site
Des Moines, Iowa, 50314
Study site
Detroit, Michigan, 48202-2689
Study site
Fort Lauderdale, Florida, 33308
Study site
Frederick, Maryland, 21701
Study site
Hoover, Alabama, 35216
Study site
Houma, Louisiana, 70360
Study site
Houston, Texas, 77030
Study site
Inverness, Florida, 34452
Study site
Jacksonville, Florida, 32207
Study site
Jefferson City, Missouri, 65109
Study site
Kalamazoo, Michigan, 49007
Study site
Kingston, Pennsylvania, 18704
Study site
Knoxville, Tennessee, 37920
Study site
Mayfield Heights, Ohio, 44124
Study site
Miami Shores, Florida, 33179
Study site
Overland Park, Kansas, 66210
Study site
Paramus, New Jersey, 07652
Study site
Port Saint Lucie, Florida, 34952
Study site
Poway, California, 92064
Study site
Rockville, Maryland, 20850-3348
Study site
Saint Joseph, Missouri, 64507
Study site
Skokie, Illinois, 60076
Study site
Summit, New Jersey, 07901
Study site
Tamarac, Florida, 33321
Study site
Tucson, Arizona, 85715
Study site
Urbana, Illinois, 61801
Study site
Walla Walla, Washington, 99362
Study site
Williamsville, New York, 14221
India15 sites
Study site
Ahmedabad, 380 016
Study site
Bangalore, 560 078
Study site
Bangalore, 560027
Study site
Hyderabad, 500 033
Study site
Hyderabad, 500 034
Study site
Hyderabad, 500 082
Study site
Jaipur, 302013
Study site
Kochi, 682 026
Study site
Kolkata, 700 053
Study site
Ludhiana, 141 001
Study site
Manipal, 576 104
Study site
Mumbai, 400012
Study site
New Delhi, 110085
Study site
Trivandrum, 695 011
Study site
Vellore, 632 004
Russia12 sites
Study site
Chelyabinsk, 454087
Study site
Ivanovo, 153040
Study site
Kazan', 420029
Study site
Kazan', 420111
Study site
Moscow, 109033
Study site
Moscow, 115478
Study site
Omsk, 644013
Study site
Ryazan, 390046
Study site
Saint Petersburg, 197022
Study site
Saint Petersburg, 197758
Study site
Samara, 443031
Study site
Yaroslavl, 150054
China8 sites
Study site
Beijing, 100021
Study site
Beijing, 100853
Study site
Bengbu, 233004
Study site
Dalian, 116011
Study site
Dalian, 116027
Study site
Hangzhou, 310009
Study site
Shanghai, 200032
Study site
Tianjin, 300060
Czechia5 sites
Study site
Pardubice, 532 03
Study site
Prague, 140 59
Study site
Prague, 150 06
Study site
Prague, 180 00
Study site
Tábor, 390 03
Bosnia and Herzegovina3 sites
Study site
Mostar, 88000
Study site
Sarajevo, 71000
Study site
Tuzla, 75000
South Africa3 sites
Study site
Bloemfontein, 9301
Study site
Durban, 4001
Study site
Polokwane, 0699
Thailand3 sites
Study site
Bangkok, 10400
Study site
Chiang Mai, 50200
Study site
Khon Kaen, 40002
About this study
Official title: A Randomized, Open-label Study of the Effect of Different Dosing Regimens of Xeloda® in Combination With Taxotere® on Disease Progression in Patients With Locally Advanced and/or Metastatic Breast Cancer
This 2 arm study compared the efficacy and safety of label dose of capecitabine (Xeloda®) to that of a lower dose of Xeloda® plus docetaxel (Taxotere®) in patients with locally advanced or metastatic breast cancer after failure of chemotherapy with an anthracycline. Patients were randomized to receive either 1250 mg/m^2 or 825 mg/m^2 orally twice a day (po bid) on days 1-14 of each 3 week cycle, in combination with Taxotere® 75 mg/m2 intravenous (iv) on day 1 of each 3 week cycle. The anticipated time on study treatment was until disease progression and the target sample size was 440 individuals.
- Conditions
- Breast Cancer
- Being tested
- capecitabine (Xeloda®), docetaxel (Taxotere®)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capecitabine (Xeloda®)Drug
Also called Xeloda®
825 mg/m^2 or 1250 mg/m2 orally twice a day on days 1 to 14 of each 3 week cycle.
docetaxel (Taxotere®)Drug
Also called Taxotere®
75 mg/m^2 intravenous on day 1 of each 3 week cycle
| Study group | Role | What they receive |
|---|---|---|
| 1250 mg/m^2 capecitabine + docetaxel | Experimental | 1250 mg/m^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m^2 intravenous on day 1 of each 3 week cycle. Receives: Drug: capecitabine (Xeloda®); Drug: docetaxel (Taxotere®) |
| 825 mg/m^2 capecitabine + docetaxel | Experimental | 825 mg/m^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m^2 intravenous on day 1 of each 3 week cycle. Receives: Drug: capecitabine (Xeloda®); Drug: docetaxel (Taxotere®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Progression of Disease or Death
Progression Free Survival was defined as the time from the date of randomization to the day of documented disease progression or death due to any cause.
Measured: Event driven (after 350 events). Median observation time was approximately 16 months.
Secondary outcomes (6)
Percentage of Participants With Best Overall Response Being Complete Response (CR) or Partial Response (PR)
According to Response Evaluation Criteria in Solid Tumors (RECIST) criteria: CR is defined as the disappearance of all target lesions and PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the nadir sum LD.
Measured: Until Progressive Disease (PD) or end of primary study treatment (up to 16 cycles) plus 28 days.
Time to Overall Response
For patients with Best Overall Response being Complete Response (CR) or Partial Response (PR), time to response was measured as the time from randomization to the first time when the measurement criteria for CR or PR were met. The percentage of participants with overall response within the given time ranges in each of the categories: Weeks 1-6, 7-12, 13-18, 19-24, 25-30, 31-36, and 43-48 are reported.
Measured: Until PD or end of primary study treatment (up to 16 cycles) plus 28 days.
Duration of Overall Response
Duration of overall response was measured from the time that measurement criteria were first met for Complete Response or Partial Response until the first date that progressive disease or death was documented.
Measured: Until PD or death. Median duration of response was approximately 7 months.
Time to Treatment Failure
The time to treatment failure was the time from the date of randomization to the first occurrence of any of the following events:
- adverse events
- insufficient therapeutic response (disease progression)
- death
- failure to return
- refusing treatment/being unwilling to cooperate
- withdrawing consent.
Measured: Until premature withdrawal or end of primary study treatment (up to 16 cycles).
Overall Survival
Overall Survival was measured as the time from the date of randomization to the date of death.
Measured: Throughout the study. Median observation time was approximately 16 months.
Number of Participants With Adverse Events and Serious Adverse Events
An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events.
A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is Life-Threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
Additional information about Adverse Events can be found in the Adverse Event Section.
Measured: First study drug intake until last study drug intake plus 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2004 (estimated)
- Study startJul 2003
- Primary completionMar 2010
- 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 Breast CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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
- 470 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00077857
- Sponsor's protocol ID
- NO16853
- Status last verified
- Mar 2013
- First submitted
- 12 Feb 2004
- Last updated
- 10 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label Study of the Effect of Different Dosing Regimens of Xeloda® in Combination With Taxotere® on Disease Progression in Patients With Locally Advanced and/or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00077857
- Acronym / sponsor ID
- NO16853
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 470 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jul 2003
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 16 Feb 2004 (estimated)
- Results
- Posted 10 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This 2 arm study compared the efficacy and safety of label dose of capecitabine (Xeloda®) to that of a lower dose of Xeloda® plus docetaxel (Taxotere®) in patients with locally advanced or metastatic breast cancer after failure of chemotherapy with an anthracycline. Patients were randomized to receive either 1250 mg/m^2 or 825 mg/m^2 orally twice a day (po bid) on days 1-14 of each 3 week cycle, in combination with Taxotere® 75 mg/m2 intravenous (iv) on day 1 of each 3 week cycle. The anticipated time on study treatment was until disease progression and the target sample size was 440 individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1250 mg/m^2 capecitabine + docetaxel | Experimental | Drug: capecitabine (Xeloda®), Drug: docetaxel (Taxotere®)1250 mg/m^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m^2 intravenous on day 1 of each 3 week cycle. |
| 825 mg/m^2 capecitabine + docetaxel | Experimental | Drug: capecitabine (Xeloda®), Drug: docetaxel (Taxotere®)825 mg/m^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m^2 intravenous on day 1 of each 3 week cycle. |
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)
- women >=18 years of age;
- >=1 target lesion;
- locally advanced or metastatic breast cancer;
- demonstrated resistance to anthracycline;
- >=2 regimens of chemotherapy for advanced/metastatic disease.
Key exclusion criteria (2 listed)
- previous treatment with Xeloda, continuous 5-fluorouracil infusion, or other oral fluoropyrimidines;
- previous treatment with paclitaxel or docetaxel for advanced/metastatic disease.
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 |
|---|---|---|
| capecitabine (Xeloda®)Also: Xeloda®825 mg/m^2 or 1250 mg/m2 orally twice a day on days 1 to 14 of each 3 week cycle. | Drug | 1250 mg/m^2 capecitabine + docetaxel, 825 mg/m^2 capecitabine + docetaxel |
| docetaxel (Taxotere®)Also: Taxotere®75 mg/m^2 intravenous on day 1 of each 3 week cycle | Drug | 1250 mg/m^2 capecitabine + docetaxel, 825 mg/m^2 capecitabine + docetaxel |
Primary outcome
Time to Progression of Disease or Death
Time frame: Event driven (after 350 events). Median observation time was approximately 16 months.
Progression Free Survival was defined as the time from the date of randomization to the day of documented disease progression or death due to any cause.
6 secondary outcomes
Percentage of Participants With Best Overall Response Being Complete Response (CR) or Partial Response (PR)
Time frame: Until Progressive Disease (PD) or end of primary study treatment (up to 16 cycles) plus 28 days.
Time to Overall Response
Time frame: Until PD or end of primary study treatment (up to 16 cycles) plus 28 days.
Duration of Overall Response
Time frame: Until PD or death. Median duration of response was approximately 7 months.
Time to Treatment Failure
Time frame: Until premature withdrawal or end of primary study treatment (up to 16 cycles).
Overall Survival
Time frame: Throughout the study. Median observation time was approximately 16 months.
Number of Participants With Adverse Events and Serious Adverse Events
Time frame: First study drug intake until last study drug intake plus 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
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.
Clinical Trials study director
Hoffmann-La Roche
94 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing capecitabine (Xeloda®) and docetaxel (Taxotere®) in people with Breast Cancer, run by Hoffmann-La Roche at 94 sites in 9 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 2 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 10 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 94 sites in United States, India, Russia, China, Czechia and 4 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 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 10 May 2013). 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 Progression of Disease or Death (time frame: Event driven (after 350 events). Median observation time was approximately 16 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2013.