Clinical trial · Interventional
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
NCT00107393CI-TRIAL-00011305completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine | Drug | Capecitabine | ALIAS |
| trastuzumab | Biological | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Median survival and 2-year survival rate as measured by the Kaplan-Meier method 2 years after completion of study treatment
Secondary outcomes (4)
- measure
- Progression-free survival
- measure
- Response rate
- measure
- Clinical benefit rate as measured by Kaplan-Meier method 2 years after completion of study treatment
- measure
- Safety profile as measured by the Kaplan-Meier method 2 years after completion of study treatment
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* 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
PATIENT CHARACTERISTICS:
Age
* 20 to 75
Sex
* Female
Menopausal status
* Not specified
Performance status
* ECOG 0-2
Life expectancy
* At least 3 months
Hematopoietic
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 9.0 g/dL
Hepatic
* 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
Renal
* Creatinine ≤ 1.2 mg/dL
Cardiovascular
* LVEF \> 50%
Pulmonary
* No interstitial pneumonia with pulmonary fibrosis
Other
* No history of hypersensitivity reactions
* No serious, uncontrolled infection
* No other malignancy
* Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Prior trastuzumab (Herceptin®) for metastatic disease allowed
Chemotherapy
* 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
Radiotherapy
* No prior radiotherapy to target lesions
* At least 4 weeks since prior radiotherapy
* No concurrent radiotherapy, including radiotherapy for brain metastases
Surgery
* Not specified
Other
* Concurrent bisphosphonates for bone metastases allowedReferences
Publications (1)
- RESULTIshida T, Kiba T, Takeda M, Matsuyama K, Teramukai S, Ishiwata R, Masuda N, Takatsuka Y, Noguchi S, Ishioka C, Fukushima M, Ohuchi N. Phase II study of capecitabine and trastuzumab combination chemotherapy in patients with HER2 overexpressing metastatic breast cancers resistant to both anthracyclines and taxanes. Cancer Chemother Pharmacol. 2009 Jul;64(2):361-9. doi: 10.1007/s00280-008-0882-8. Epub 2008 Dec 12. PMID 19082596