A Study to Assess Capecitabine (Xeloda®) in Patients With Locally Advanced or Metastatic Breast Cancer

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: capecitabine (Xeloda®); Drug: docetaxel (Taxotere®)

• Study Type: Interventional
• Enrollment (Actual): 470
• Phase: Phase 2

Contacts and Locations

Study Locations

• Bosnia and Herzegovina
  • Mostar, Bosnia and Herzegovina, 88000
  • Sarajevo, Bosnia and Herzegovina, 71000
  • Tuzla, Bosnia and Herzegovina, 75000
• China
  • Beijing, China, 100021
  • Beijing, China, 100853
  • Bengbu, China, 233004
  • Dalian, China, 116011
  • Dalian, China, 116027
  • Hangzhou, China, 310009
  • Shanghai, China, 200032
  • Tianjin, China, 300060
• Czech Republic
  • Pardubice, Czech Republic, 532 03
  • Praha, Czech Republic, 150 06
  • Praha, Czech Republic, 140 59
  • Praha, Czech Republic, 180 00
  • Tabor, Czech Republic, 390 03
• India
  • Ahmedabad, India, 380 016
  • Bangalore, India, 560 078
  • Bangalore, India, 560027
  • Cochin, India, 682 026
  • Hyderabad, India, 500 033
  • Hyderabad, India, 500 034
  • Hyderabad, India, 500 082
  • Jaipur, India, 302013
  • Kolkata, India, 700 053
  • Ludhiana, India, 141 001
  • Manipal, India, 576 104
  • Mumbai, India, 400012
  • New Delhi, India, 110085
  • Trivandrum, India, 695 011
  • Vellore, India, 632 004
• Poland
  • Poznan, Poland, 61-878
  • Wroclaw, Poland, 50-981
• Russian Federation
  • Chelyabinsk, Russian Federation, 454087
  • Ivanovo, Russian Federation, 153040
  • Kazan, Russian Federation, 420029
  • Kazan, Russian Federation, 420111
  • Moscow, Russian Federation, 115478
  • Moscow, Russian Federation, 109033
  • Omsk, Russian Federation, 644013
  • Ryazan, Russian Federation, 390046
  • Samara, Russian Federation, 443031
  • St Petersburg, Russian Federation, 197022
  • St Petersburg, Russian Federation, 197758
  • Yaroslavl, Russian Federation, 150054
• South Africa
  • Bloemfontein, South Africa, 9301
  • Durban, South Africa, 4001
  • Polokwane, South Africa, 0699
• Thailand
  • Bangkok, Thailand, 10400
  • Chiang Mai, Thailand, 50200
  • Khon Kaen, Thailand, 40002
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
    • Hoover, Alabama, United States, 35216
  • Arizona
    • Tucson, Arizona, United States, 85715
  • California
    • Berkeley, California, United States, 94704
    • Poway, California, United States, 92064
  • Florida
    • Boca Raton, Florida, United States, 33486
    • Fort Lauderdale, Florida, United States, 33308
    • Inverness, Florida, United States, 34452
    • Jacksonville, Florida, United States, 32207
    • Miami Shores, Florida, United States, 33179
    • Port Saint Lucie, Florida, United States, 34952
    • Tamarac, Florida, United States, 33321
  • Illinois
    • Skokie, Illinois, United States, 60076
    • Urbana, Illinois, United States, 61801
  • Indiana
    • Beech Grove, Indiana, United States, 46107
  • Iowa
    • Des Moines, Iowa, United States, 50314
  • Kansas
    • Overland Park, Kansas, United States, 66210
  • Louisiana
    • Houma, Louisiana, United States, 70360
  • Maryland
    • Baltimore, Maryland, United States, 21202
    • Baltimore, Maryland, United States, 21236
    • Frederick, Maryland, United States, 21701
    • Rockville, Maryland, United States, 20850-3348
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
  • Michigan
    • Detroit, Michigan, United States, 48202-2689
    • Kalamazoo, Michigan, United States, 49007
  • Missouri
    • Jefferson City, Missouri, United States, 65109
    • St Joseph, Missouri, United States, 64507
  • New Jersey
    • Paramus, New Jersey, United States, 07652
    • Summit, New Jersey, United States, 07901
  • New York
    • Williamsville, New York, United States, 14221
  • Ohio
    • Canton, Ohio, United States, 44718
    • Mayfield Heights, Ohio, United States, 44124
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18104
    • Kingston, Pennsylvania, United States, 18704
  • South Carolina
    • Charleston, South Carolina, United States, 29406
    • Columbia, South Carolina, United States, 29203
  • Tennessee
    • Collierville, Tennessee, United States, 38017
    • Knoxville, Tennessee, United States, 37920
  • Texas
    • Austin, Texas, United States, 78705
    • Houston, Texas, United States, 77030
  • Vermont
    • Colchester, Vermont, United States, 05446
  • Virginia
    • Abingdon, Virginia, United States, 24211
  • Washington
    • Walla Walla, Washington, United States, 99362

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• previous treatment with Xeloda, continuous 5-fluorouracil infusion, or other oral fluoropyrimidines;
• previous treatment with paclitaxel or docetaxel for advanced/metastatic disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1250 mg/m^2 capecitabine + docetaxel; 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.	Drug: capecitabine (Xeloda®); 825 mg/m^2 or 1250 mg/m2 orally twice a day on days 1 to 14 of each 3 week cycle.; Other Names: Xeloda®; Drug: docetaxel (Taxotere®); 75 mg/m^2 intravenous on day 1 of each 3 week cycle; Other Names: Taxotere®
EXPERIMENTAL: 825 mg/m^2 capecitabine + docetaxel; 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.	Drug: capecitabine (Xeloda®); 825 mg/m^2 or 1250 mg/m2 orally twice a day on days 1 to 14 of each 3 week cycle.; Other Names: Xeloda®; Drug: docetaxel (Taxotere®); 75 mg/m^2 intravenous on day 1 of each 3 week cycle; Other Names: Taxotere®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Event driven (after 350 events). Median observation time was approximately 16 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	First study drug intake until last study drug intake plus 28 days

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: July 1, 2003
• Primary Completion (ACTUAL): March 1, 2010
• Study Completion (ACTUAL): March 1, 2010

Study Registration Dates

• First Submitted: February 12, 2004
• First Submitted That Met QC Criteria: February 13, 2004
• First Posted (ESTIMATE): February 16, 2004

Study Record Updates

• Last Update Posted (ESTIMATE): May 10, 2013
• Last Update Submitted That Met QC Criteria: March 27, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel; Capecitabine
• Other Study ID Numbers: NO16853