Trastuzumab and Capecitabine in Treating Women With Metastatic Breast Cancer

NCT00107393 | Completed Phase 2

• 2 other identifiers: TUGSM-UHA-BC03-01CDR0000380787
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 10

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.

Conditions

Breast Cancer

Keywords

recurrent breast cancer; stage IV breast cancer

Outcome Measures

Primary Outcomes (1)

• Median survival and 2-year survival rate as measured by the Kaplan-Meier method 2 years after completion of study treatment

Secondary Outcomes (4)

• Progression-free survival

• Response rate

• Clinical benefit rate as measured by Kaplan-Meier method 2 years after completion of study treatment

• Safety profile as measured by the Kaplan-Meier method 2 years after completion of study treatment

Interventions

trastuzumab BIOLOGICAL

capecitabine DRUG

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 allowed

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Tohoku University: lead

Study Sites (10)

Kitakyushu Municipal Medical Center

Fukuoka, 802-0077, Japan

Location

Hiroshima University Hospital

Hiroshima, 734-8551, Japan

Location

Hokkaido Cancer Center

Hokkaido, 003-0804, Japan

Location

Saint Marianna University School of Medicine

Kanagawa, 216-8511, Japan

Location

National Hospital Organization - Osaka National Hospital

Osaka, 540-0006, Japan

Location

Osaka Kosei Nenkin Hospital

Osaka, 553-0003, Japan

Location

Osaka University Graduate School of Medicine

Osaka, 565-0871, Japan

Location

Tohoku University Graduate School of Medicine

Sendai, 980-8574, Japan

Location

St. Luke's International Hospital

Tokyo, 104-8560, Japan

Location

Sakata Municipal Hospital

Yamagata, 998-8585, Japan

Location

Related Publications (1)

• Ishida 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 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab; Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Noriaki Ohuchi, MD

  Tohoku University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 5, 2005
• First Posted: April 6, 2005
• Study Start: June 1, 2003
• Primary Completion: May 1, 2008
• Study Completion: November 1, 2008
• Last Updated: July 10, 2013

Record last verified: 2006-10

Locations

JP (10)