Working… Menu

Trastuzumab and Capecitabine in Treating Women With 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: NCT00107393
Recruitment Status : Completed
First Posted : April 6, 2005
Last Update Posted : July 10, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. 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. Giving trastuzumab together with capecitabine may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving trastuzumab together with capecitabine works in treating women with metastatic breast cancer.

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

Detailed Description:



  • Determine the median survival time and 2-year survival rate in women with taxane- and anthracycline-refractory HER2/neu-overexpressing metastatic breast cancer treated with trastuzumab (Herceptin®) and capecitabine.


  • Determine the progression-free survival of patients treated with this regimen.
  • Determine the response rate in patients treated with this regimen.
  • Determine the clinical benefit rate of this regimen in these patients.
  • Determine the safety profile of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to prior treatment with trastuzumab (Herceptin®) (yes vs no), HER2/neu status (3+ by immunohistochemistry vs positive by fluorescence in situ hybridization), and class of refractory disease (primary vs secondary vs treatment discontinuation due to adverse events).

Patients receive oral capecitabine once daily on days 1-21 and trastuzumab IV on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for up to 2 years.

PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study within 3 years.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Trastuzumab (Herceptin) and Capecitabine (Xeloda) in Women With Taxanes and Anthracyclines Refractory Metastatic Breast Cancer and HER2 Over-Expression
Study Start Date : June 2003
Actual Primary Completion Date : May 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Primary Outcome Measures :
  1. Median survival and 2-year survival rate as measured by the Kaplan-Meier method 2 years after completion of study treatment

Secondary Outcome Measures :
  1. Progression-free survival
  2. Response rate
  3. Clinical benefit rate as measured by Kaplan-Meier method 2 years after completion of study treatment
  4. Safety profile as measured by the Kaplan-Meier method 2 years after completion of study treatment

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Histologically confirmed breast cancer

    • Metastatic disease

      • Patients with only bone metastases are not eligible
  • Refractory disease, defined as disease progression, drug-related adverse reaction, or disease relapse during or within 12 months after completion of paclitaxel or docetaxel AND doxorubicin or epirubicin administered in the neoadjuvant, adjuvant, or metastatic setting

    • Total neoadjuvant or adjuvant taxane dose > 700 mg/m^2 for paclitaxel or > 240 mg/m^2 for docetaxel
    • Total taxane dose > 350 mg/m^2 for paclitaxel or > 120 mg/m^2 for docetaxel in the metastatic setting
    • Total neoadjuvant or adjuvant anthracycline dose > 240 mg/m^2 for doxorubicin or epirubicin
    • Total anthracycline dose > 120 mg/m^2 for doxorubicin or epirubicin in the metastatic setting
  • HER2/neu overexpression

    • 3+ by immunohistochemistry or positive by fluorescence in situ hybridization
  • No symptomatic brain metastases
  • No pleural or pericardial effusion or ascites
  • Hormone receptor status:

    • Not specified



  • 20 to 75


  • Female

Menopausal status

  • Not specified

Performance status

  • ECOG 0-2

Life expectancy

  • At least 3 months


  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9.0 g/dL


  • SGOT or SGPT ≤ 2.0 times upper limit of normal (ULN) (< 3.0 times ULN for patients with liver metastases)
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Bilirubin ≤ 1.5 mg/dL


  • Creatinine ≤ 1.2 mg/dL


  • LVEF > 50%


  • No interstitial pneumonia with pulmonary fibrosis


  • No history of hypersensitivity reactions
  • No serious, uncontrolled infection
  • No other malignancy
  • Not pregnant or nursing


Biologic therapy

  • Prior trastuzumab (Herceptin®) for metastatic disease allowed


  • See Disease Characteristics
  • No prior capecitabine
  • At least 2 weeks since prior antimetabolites for metastatic disease
  • At least 4 weeks since prior alkylating agents, carcinostatic antibiotics, or other carcinostatic agents

Endocrine therapy

  • At least 4 weeks since prior goserelin or leuprolide for metastatic disease
  • At least 2 weeks since prior oral endocrine agents for metastatic disease
  • No concurrent endocrine therapy


  • No prior radiotherapy to target lesions
  • At least 4 weeks since prior radiotherapy
  • No concurrent radiotherapy, including radiotherapy for brain metastases


  • Not specified


  • Concurrent bisphosphonates for bone metastases allowed

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): NCT00107393

Layout table for location information
Kitakyushu Municipal Medical Center
Fukuoka, Japan, 802-0077
Hiroshima University Hospital
Hiroshima, Japan, 734-8551
Hokkaido Cancer Center
Hokkaido, Japan, 003-0804
Saint Marianna University School of Medicine
Kanagawa, Japan, 216-8511
National Hospital Organization - Osaka National Hospital
Osaka, Japan, 540-0006
Osaka Kosei Nenkin Hospital
Osaka, Japan, 553-0003
Osaka University Graduate School of Medicine
Osaka, Japan, 565-0871
Tohoku University Graduate School of Medicine
Sendai, Japan, 980-8574
St. Luke's International Hospital
Tokyo, Japan, 104-8560
Sakata Municipal Hospital
Yamagata, Japan, 998-8585
Sponsors and Collaborators
Tohoku University
Layout table for investigator information
Study Chair: Noriaki Ohuchi, MD Tohoku University

Publications of Results:
Layout table for additonal information Identifier: NCT00107393     History of Changes
Other Study ID Numbers: TUGSM-UHA-BC03-01
CDR0000380787 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: April 6, 2005    Key Record Dates
Last Update Posted: July 10, 2013
Last Verified: October 2006
Keywords provided by National Cancer Institute (NCI):
recurrent breast cancer
stage IV breast cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Immunological