Trastuzumab and Capecitabine in Treating Women With Metastatic Breast Cancer
Phase II Study of Trastuzumab (Herceptin) and Capecitabine (Xeloda) in Women With Taxanes and Anthracyclines Refractory Metastatic Breast Cancer and HER2 Over-Expression
  • Phase

    Phase 2
  • Study Type

  • Status

    Completed No Results Posted
  • Study Participants

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.


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.
Study Started
Jun 30
Primary Completion
May 31
Study Completion
Nov 30
Last Update
Jul 10

Biological trastuzumab

Drug capecitabine



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



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
No Results Posted