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Capecitabine in Treating Patients With Metastatic Breast Cancer

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center Identifier:
First received: January 10, 2006
Last updated: October 9, 2015
Last verified: October 2015

RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well capecitabine works in treating patients with metastatic breast cancer.

Condition Intervention Phase
Breast Cancer
Drug: capecitabine
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Fixed-Dose Capecitabine in Metastatic Breast Cancer

Resource links provided by NLM:

Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • Response Rate [ Time Frame: Participants were followed to progression, evaluated every 12 weeks ]
    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Secondary Outcome Measures:
  • Clinical Benefit, Time to Treatment Failure, Safety and Toxicity [ Time Frame: Time to progression ]
  • Pharmacokinetic and Pharmacodynamic Effects [ Time Frame: Time to progression ]
  • Adherence and Compliance to Oral Medication Using Electronic Monitoring [ Time Frame: Every 3 weeks ]

Enrollment: 26
Study Start Date: April 2004
Study Completion Date: November 2012
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Capecitabine Drug: capecitabine

Detailed Description:



  • Determine the response rate in patients with metastatic breast cancer treated with a fixed-dose of capecitabine.


  • Determine the clinical benefit, time to treatment failure (TTF), safety, and toxicity profile of this regimen in these patients.
  • Determine the pharmacokinetics (PK) and pharmacogenetics in these patients.
  • Correlate pharmacodynamic effects of this drug with toxicity and response in these patients.
  • Determine compliance and adherence to this regimen and correlate with PK parameters in these patients.

OUTLINE: This is an open-label study.

Patients receive a fixed-dose of oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study.


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


  • Histologically or cytologically confirmed diagnosis of adenocarcinoma of the breast

    • Evidence of metastatic involvement (stage IV disease)
  • Patients must have measurable disease

    • At least one measurable lesion as defined by the Response Evaluation Criteria in Solid Tumors (RECIST)
  • Treated brain metastases (surgery or radiation therapy) allowed if clinically stable
  • Patients with leptomeningeal disease are ineligible
  • Hormone receptor status:

    • Not specified


  • ECOG (Eastern Cooperative Oncology Group) performance status 0-2
  • Male or female
  • Menopausal status not specified
  • Absolute neutrophil count (ANC) ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Creatinine clearance > 50 mL/min
  • Fertile patients must use effective contraception
  • No history of another severe and/or life-threatening medical disease
  • No other active primary malignancy
  • Not pregnant or nursing
  • Negative pregnancy test
  • Patients with asymptomatic HIV infection are eligible
  • Liver dysfunction score ≤ 9
  • No pre-existing liver disease (i.e., cirrhosis or active viral hepatitis)
  • No active gastrointestinal malabsorption illness
  • No clinically significant cardiac disease, including the following:

    • Congestive heart failure, symptomatic coronary artery disease, and cardiac arrhythmias not well controlled with medication, or myocardial infarction within the past six months
  • No prior unanticipated severe reaction to fluoropyrimidine therapy, known hypersensitivity to fluorouracil, or known dihydropyrimidine dehydrogenase deficiency
  • No history of uncontrolled seizures or central nervous system disorders
  • No significant history of noncompliance to medical regimens
  • No clinically significant psychiatric disability that would preclude study compliance


  • No previous capecitabine
  • Up to 3 prior cytotoxic regimens allowed for metastatic disease

    • Prior noncytotoxic therapy allowed (e.g., hormonal treatment or trastuzumab)
  • No other concurrent therapies intended to treat the primary condition including chemotherapy, biologic agents, or immunotherapy
  • No concurrent anti-estrogen therapy, radiation therapy, or investigational systemic therapy
  • No other concurrent investigational drugs
  • No concurrent use of the following drugs: warfarin for full anticoagulation, cimetidine, or azidothymidine (AZT)

    • Mini-dose warfarin for prophylaxis of central venous catheter thrombosis allowed
  • At least 4 weeks since prior sorivudine or brivudine
  • Concurrent use of bisphosphonates allowed if initiated before beginning study therapy
  • Concurrent use of megestrol acetate suspension as an appetite stimulant allowed
  Contacts and Locations
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Please refer to this study by its identifier: NCT00274768

United States, Maryland
DeCesaris Cancer Institute at Anne Arundel Medical Center
Annapolis, Maryland, United States, 21401
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Antonio C. Wolff, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sidney Kimmel Comprehensive Cancer Center Identifier: NCT00274768     History of Changes
Other Study ID Numbers: J0425 CDR0000446286
P30CA006973 ( US NIH Grant/Contract Award Number )
JHOC-J0425 ( Other Identifier: SKCCC )
JHOC-SKCCC-J0425 ( Other Identifier: SKCCC )
JHOC-IRB-04032502 ( Other Identifier: SKCCC )
Study First Received: January 10, 2006
Results First Received: November 21, 2012
Last Updated: October 9, 2015

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
stage IV breast cancer
male breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents processed this record on April 25, 2017