Breast CancerPhase 4NCT00087620
A Study of Capecitabine In Combination With Docetaxel vs Capecitabine Followed by Docetaxel As First-Line Treatment For Metastatic Breast Cancer
A Phase 4 study testing XELODA [capecitabine] in people with Breast Cancer, run by Hoffmann-La Roche at 35 sites in United States.
Trial summary
To evaluate and compare the time to progression of the combination of capecitabine (825 mg/m2 twice daily) and docetaxel (75mg/m2 i.v.) to that of capecitabine (1000 mg/m2 twice daily) until progressive disease followed sequentially by docetaxel (75 mg/m2 i.v. D1 Q3W). 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?
- XELODA [capecitabine]
- How many people
- Not given
- Where
- 35 sitesUnited States
- Study dates
- Sep 2004to Oct 2004
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Have provided written informed consent prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice
- Be female and at least 18 years of age. Note: must be 19 years of age if the patient is a resident of the state of Alabama
- Be ambulatory (outpatient) and have a Karnofsky performance status of more than 70%
- Have confirmed breast cancer with locally advanced and/or metastases
- Have at least one site with defined tumor
- Have met one of the study definitions of primary or nonprimary resistance to an anthracycline-containing therapy
Who cannot join
- Pregnant/lactating women
- Women of childbearing potential with either a positive or no pregnancy test
- Women of childbearing potential unless using a reliable and appropriate contraceptive method (Postmenopausal women must have not had their period for at least 12 months to be considered of non-childbearing potential)
- Prior treatment with chemotherapy in the advanced/metastatic setting
- HER 2/neu positive status without prior treatment with trastuzumab
- Prior treatment with IV bolus 5-FU, continuous 5-FU infusion, capecitabine or other oral fluoropyrimidines
Show all 26Show fewer
- Prior treatment with a taxane if less than 12 months passed from the time of therapy completion to relapse
- Mitomycin C or nitrosoureas within 6 weeks preceding treatment start
- Organ allografts requiring immunosuppressive therapy
- Radiotherapy to the skeleton within 4 weeks of study treatment start or insufficient recovery from the effects of prior radiotherapy
- Hormonal therapy within 10 days preceding study treatment start
- Major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from the effects of major surgery
- Blood transfusions/growth factors to aid hematologic recovery within 2 weeks prior to study treatment start
- Participation in any investigational drug study within 4 weeks preceding treatment start
- Prior unanticipated severe reaction to fluoropyrimidine therapy
- Known hypersensitivity to 5-fluorouracil, taxanes or any of the components of capecitabine
- Requirement for concurrent use of the antiviral agent sorivudine or chemically related analogues
- Evidence of CNS metastases
- History of another malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma
- Clinically significant (i.e. active) cardiac disease
- Abnormal laboratory values
- Severe renal impairment
- Serious uncontrolled intercurrent infections, or other serious uncontrolled concomitant disease
- Lack of physical integrity of the upper GI tract
- Life expectancy of less than 3 months
- Unwilling/unable to comply with the protocol
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
United States35 sites
Study site
Augusta, Georgia, 30901
Study site
Aurora, Colorado, 80010
Study site
Baltimore, Maryland, 21237
Study site
Boca Raton, Florida, 33428
Study site
Boynton Beach, Florida, 33435
Study site
Brooksville, Florida, 34613
Study site
Chicago, Illinois, 60611
Study site
Corpus Christi, Texas, 78412
Study site
Deer Park, California, 94576
Study site
Durham, North Carolina, 27710
Study site
Florence, South Carolina, 29506
Study site
Greenbrae, California, 94904
Study site
Hollywood, Florida, 33021
Study site
La Jolla, California, 92037
Study site
Lafayette, Louisiana, 70503
Study site
Lansing, Michigan, 48909
Study site
Lenexa, Kansas, 66214
Study site
Little Rock, Arkansas, 72205
Study site
Los Angeles, California, 90057
Study site
Milwaukee, Wisconsin, 53215
Study site
Minneapolis, Minnesota, 55455
Study site
New Port Richey, Florida, 34652
Study site
Oklahoma City, Oklahoma, 73112
Study site
Orange, California, 92868
Study site
Prince Frederick, Maryland, 20678
Study site
Racine, Wisconsin, 53405
Study site
Reno, Nevada, 89502
Study site
Richardson, Texas, 75080
Study site
Rochester, New York, 14642
Study site
Savannah, Georgia, 31405
Study site
Scarborough, Maine, 04074
Study site
Skokie, Illinois, 60077
Study site
Waterloo, Iowa, 50702
Study site
Wilmington, North Carolina, 28401
Study site
Winston-Salem, North Carolina, 27103
About this study
To evaluate and compare the time to progression of the combination of capecitabine (825 mg/m2 twice daily) and docetaxel (75mg/m2 i.v.) to that of capecitabine (1000 mg/m2 twice daily) until progressive disease followed sequentially by docetaxel (75 mg/m2 i.v. D1 Q3W).
- Conditions
- Breast Cancer
- Being tested
- XELODA [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.
XELODA [capecitabine]Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2004 (estimated)
- Study startSep 2004
- Primary completionOct 2004
- Study completionOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00087620
- Sponsor's protocol ID
- ML17771
- Status last verified
- Feb 2017
- First submitted
- 12 Jul 2004
- Last updated
- 3 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Capecitabine In Combination With Docetaxel vs Capecitabine Followed by Docetaxel As First-Line Treatment For Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00087620
- Acronym / sponsor ID
- ML17771
- Conditions
- Breast Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Sep 2004 (actual)
- Primary completion
- Oct 2004 (actual)
- Study completion
- Oct 2004 (actual)
- First posted
- 14 Jul 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate and compare the time to progression of the combination of capecitabine (825 mg/m2 twice daily) and docetaxel (75mg/m2 i.v.) to that of capecitabine (1000 mg/m2 twice daily) until progressive disease followed sequentially by docetaxel (75 mg/m2 i.v. D1 Q3W).
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have provided written informed consent prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice
- Be female and at least 18 years of age. Note: must be 19 years of age if the patient is a resident of the state of Alabama
- Be ambulatory (outpatient) and have a Karnofsky performance status of more than 70%
- Have confirmed breast cancer with locally advanced and/or metastases
- Have at least one site with defined tumor
Key exclusion criteria (26 listed)
- Pregnant/lactating women
- Women of childbearing potential with either a positive or no pregnancy test
- Women of childbearing potential unless using a reliable and appropriate contraceptive method (Postmenopausal women must have not had their period for at least 12 months to be considered of non-childbearing potential)
- Prior treatment with chemotherapy in the advanced/metastatic setting
- HER 2/neu positive status without prior 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 |
|---|---|---|
| XELODA [capecitabine] | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing XELODA [capecitabine] in people with Breast Cancer, run by Hoffmann-La Roche at 35 sites in United States.
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 6 inclusion and 26 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: stopped early, as of the sponsor's last update on 3 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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.
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 3 Feb 2017.