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Phase 4
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information


Inclusion Criteria:



- 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

Exclusion Criteria:

- 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

- 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

ML17771

NCT ID:

NCT00087620

Start Date:

Completion Date:

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

Name

Location

Hinsdale, Illinois  60521
Bettendorf, Iowa  52722
Alexandria, Minnesota  56308
Albany, Georgia  31701
Fountain Valley, California  92708
Miami, Florida  33176
Albany, New York  12208
Austin, Texas  78705
Flint, Michigan  48532
Little Rock, Arkansas  72205-7199
Kansas City, Kansas  66160
Scarborough, Maine  04074
Metairie, Louisiana  70006
Denver, Colorado  
Baltimore, Maryland  21287
Charlotte, North Carolina  
Milwaukee, Wisconsin  
Charleston, South Carolina  
Tulsa, Oklahoma  
Las Vegas, Nevada  89109