A Study of Xeloda (Capecitabine) in Women With HER2-Negative Metastatic Breast Cancer

NCT ID: NCT00121836

Last Updated: 2011-04-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2008-12-31

Brief Summary

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This single-arm study was designed to evaluate the efficacy and safety of oral Xeloda plus intravenous Avastin as first-line treatment in women with metastatic breast cancer. Patients received Xeloda 1000 mg/m² orally (PO) twice daily (BID) on Days 1-15, and Avastin 15 mg intravenously (IV) on Day 1 of each 3-week cycle. The anticipated time on study treatment was until disease progression or unacceptable toxicity. The target sample size was \<100 individuals.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Capecitabine

Intervention Type DRUG

1000 mg/m² PO BID on Days 1-15 of each 3-week cycle

Bevacizumab

Intervention Type DRUG

15 mg IV on Day 1 of each 3-week cycle

Interventions

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Capecitabine

1000 mg/m² PO BID on Days 1-15 of each 3-week cycle

Intervention Type DRUG

Bevacizumab

15 mg IV on Day 1 of each 3-week cycle

Intervention Type DRUG

Other Intervention Names

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Xeloda Avastin

Eligibility Criteria

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Inclusion Criteria

* Women \>=18 years of age
* HER2-negative metastatic breast cancer
* Previous adjuvant chemotherapy or hormonal treatment
* \>=1 measurable target lesion

Exclusion Criteria

* Previous treatment with chemotherapy, an anti-angiogenic agent, or a biologic therapy for advanced or metastatic cancer
* Radiation therapy within 4 weeks of study treatment start or insufficient recovery from the effects of prior radiation therapy
* Central nervous system metastases
* Other malignancy within last 5 years, except cured basal cell carcinoma of skin and carcinoma in situ of uterine cervix
* Serious concurrent infection
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Hoffmann-La Roche

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Birmingham, Alabama, United States

Site Status

Birmingham, Alabama, United States

Site Status

Birmingham, Alabama, United States

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Birmingham, Alabama, United States

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Birmingham, Alabama, United States

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Birmingham, Alabama, United States

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Burbank, California, United States

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Glendale, California, United States

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Glendale, California, United States

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Los Angeles, California, United States

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San Diego, California, United States

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Farmington, Connecticut, United States

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Bonita Springs, Florida, United States

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Boynton Beach, Florida, United States

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Bradenton, Florida, United States

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Cape Coral, Florida, United States

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Fort Myers, Florida, United States

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Fort Myers, Florida, United States

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Naples, Florida, United States

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Naples, Florida, United States

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Port Charlotte, Florida, United States

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Sarasota, Florida, United States

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Sarasota, Florida, United States

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Venice, Florida, United States

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Atlanta, Georgia, United States

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Augusta, Georgia, United States

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Tucker, Georgia, United States

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Chicago, Illinois, United States

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Indianapolis, Indiana, United States

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Indianapolis, Indiana, United States

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Waterloo, Iowa, United States

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Scarborough, Maine, United States

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Prince Frederick, Maryland, United States

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Lansing, Michigan, United States

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Kansas City, Missouri, United States

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Kansas City, Missouri, United States

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Kansas City, Missouri, United States

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Kansas City, Missouri, United States

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Kansas City, Missouri, United States

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Kansas City, Missouri, United States

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Lincoln, Nebraska, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Brick, New Jersey, United States

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Neptune City, New Jersey, United States

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Red Bank, New Jersey, United States

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Rochester, New York, United States

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Hickory, North Carolina, United States

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Canton, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Beaufort, South Carolina, United States

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Charleston, South Carolina, United States

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Florence, South Carolina, United States

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Hilton Head Island, South Carolina, United States

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Sumter, South Carolina, United States

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Abingdon, Virginia, United States

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Milwaukee, Wisconsin, United States

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Countries

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United States

Other Identifiers

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ML18527

Identifier Type: -

Identifier Source: org_study_id

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