Suspended
A Study of Capecitabine In Combination With Docetaxel vs Capecitabine Followed by Docetaxel As First-Line Treatment For Metastatic Breast Cancer
What is being tested
Data Collection
Who is being recruted
Breast Diseases+3
+ Breast Neoplasms
+ Neoplasms
Over 18 Years
+32 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 4
Interventional
Study Start: September 2004
Summary
Principal SponsorHoffmann-La Roche
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2004
Actual date on which the first participant was enrolled.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).
Official TitleA Study of Capecitabine In Combination With Docetaxel vs Capecitabine Followed by Docetaxel As First-Line Treatment For Metastatic Breast Cancer
Principal SponsorHoffmann-La Roche
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Breast DiseasesBreast NeoplasmsNeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases
Criteria
6 inclusion criteria required to participate
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
Show More Criteria
26 exclusion criteria prevent from participating
Severe renal impairment
Serious uncontrolled intercurrent infections, or other serious uncontrolled concomitant disease
Lack of physical integrity of the upper GI tract
Pregnant/lactating women
Show More Criteria
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has no location dataSave this study to your profile to know when the location data is available.
SuspendedNo study centers