Capecitabine in Treating Women With Advanced or Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00026442
Recruitment Status : Unknown
Verified April 2004 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : December 18, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Randomized phase II trial to compare the effectiveness of two different doses of capecitabine in treating women who have advanced or metastatic breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: capecitabine Phase 2

Detailed Description:


  • Compare the objective response rate in women with advanced or metastatic breast cancer treated with two dose levels of capecitabine.
  • Compare the duration of response, time to progression, time to treatment failure, survival, incidence of adverse events, and time to onset of the adverse experience in patients treated with this drug.
  • Compare the quality of life of patients treated with this drug.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to Karnofsky performance status (70-80% vs 90-100%) and presence of hepatic metastases (yes vs no). Patients are randomized to one of two treatment arms.

  • Arm I: Patients receive lower-dose oral capecitabine twice daily on days 1-14.
  • Arm II: Patients receive higher-dose oral capecitabine twice daily on days 1-14.

In both arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, at the end of the third and sixth courses, and at completion of therapy.

PROJECTED ACCRUAL: A total of 120 patients (60 per treatment arm) will be accrued for this study within 9 months.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Pilot Trial Of Two Different Doses Of Capecitabine (XELODA) In Patients With Advanced And/Or Metastatic Breast Cancer
Study Start Date : November 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Histologically and/or cytologically confirmed breast cancer
  • Advanced and/or metastatic disease
  • At least 1 measurable lesion

    • At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
  • No CNS metastases
  • Hormone receptor status:

    • Not specified



  • 18 and over


  • Female

Menopausal status:

  • Not specified

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • At least 12 weeks


  • Neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than 1.25 times upper limit of normal (ULN)
  • AST/ALT no greater than 2.5 times ULN (5 times ULN if liver metastases present)
  • Alkaline phosphatase no greater than 2.5 times ULN (5 times ULN if liver metastases present OR 10 times ULN if bone metastases present)
  • No hepatitis


  • Creatinine no greater than 1.5 times ULN
  • Creatinine clearance at least 50 mL/min


  • No clinically significant cardiac disease
  • No congestive heart failure
  • No symptomatic coronary artery disease
  • No cardiac arrhythmias poorly controlled with medication
  • No myocardial infarction within the past 12 months even if adequately controlled with medication


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative
  • No severe pain inadequately controlled by analgesics
  • No prior severe and unexpected reaction to fluoropyrimidine therapy
  • No known hypersensitivity to fluorouracil
  • No impaired physical integrity of the upper gastrointestinal tract
  • No malabsorption syndrome
  • No inability to swallow tablets
  • No history of uncontrolled seizures, central nervous system disorder, or psychiatric disability that would preclude study participation
  • No serious uncontrolled infection


Biologic therapy:

  • Not specified


  • At least 2 but no more than 3 prior chemotherapy regimens
  • At least 1 prior chemotherapy regimen containing paclitaxel and an anthracycline as adjuvant therapy or for advanced and/or metastatic disease

Endocrine therapy:

  • Not specified


  • No prior radiotherapy to target lesions unless there is evidence of new disease within the irradiated field
  • No concurrent radiotherapy


  • No prior organ allografts


  • At least 4 weeks since prior investigational drug
  • No concurrent enrollment on other investigational study
  • No other concurrent anticancer agents

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00026442

United States, California
Antelope Valley Hospital
Lancaster, California, United States, 93534
Medical Oncology Care Associates
Orange, California, United States, 92868
California Cancer Medical Center
West Covina, California, United States, 91790
United States, Colorado
Oncology Clinic, P.C.
Colorado Springs, Colorado, United States, 80907
United States, Florida
Hematology Oncology Associates of theTreasure Coast - Port St. Lucie
Port Saint Lucie, Florida, United States, 34952
North Florida Cancer Center
St. Augustine, Florida, United States, 32086
United States, Maryland
Maryland Hematology/Oncology Associates
Baltimore, Maryland, United States, 21236
United States, South Carolina
Charleston Hematology-Oncology, P.A.
Charleston, South Carolina, United States, 29403
United States, Tennessee
Family Cancer Center
Collierville, Tennessee, United States, 38017
United States, Utah
Logan Regional Hospital
Logan, Utah, United States, 84341
Sponsors and Collaborators
Pharmatech Oncology
Study Chair: Sandy Marcus Pharmatech Oncology Identifier: NCT00026442     History of Changes
Other Study ID Numbers: CDR0000069030
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: December 18, 2013
Last Verified: April 2004

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents