Suspended

A Study of Capecitabine In Combination With Docetaxel vs Capecitabine Followed by Docetaxel As First-Line Treatment For Metastatic Breast Cancer

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What is being tested

XELODA [capecitabine]

Drug
Who is being recruted

Breast Cancer

Over 18 Years
+32 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: September 2004

See protocol details

Summary

Principal SponsorHoffmann-La Roche
Last updated: February 3, 2017
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2004Actual 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: February 3, 2017
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.
Design Details
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
FemaleBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Breast Cancer
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

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26 exclusion criteria prevent from participating
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

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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 35 locations
Suspended
Unknown FacilityLittle Rock, United StatesSee the location
Suspended
Unknown FacilityDeer Park, United States
Suspended
Unknown FacilityGreenbrae, United States
Suspended
Unknown FacilityLa Jolla, United States
Suspended35 Study Centers