Phase II trial of weekly docetaxel, vinorelbine, and trastuzumab in the first-line treatment of patients with her2-positive metastatic breast cancer

Clinical Breast Cancer

Volumn 9, Issue 1, 2009, Pages 23-28

  Infante, Jeffrey ^a   Yardley, Denise ^a   Burris Iii, Howard ^a   Greco, F Anthony ^a   Farley, Cindy ^a   Webb, Charles ^b   Spigel, David ^a   Hainsworth, John ^a  

^a SARAH CANNON RESEARCH INSTITUTE   (United States)

^b Consultants in Blood Disorders and Cancer ^*  (United States)

Author keywords

Fluorescence in situ hybridization; Immunohistochemistry; Multiple gated acquisition scan; Neutropenia

Indexed keywords

ANTIEMETIC AGENT; DEXAMETHASONE; DOCETAXEL; EPIDERMAL GROWTH FACTOR RECEPTOR 2; GRANULOCYTE COLONY STIMULATING FACTOR; NAVELBINE; TRASTUZUMAB; ANTINEOPLASTIC AGENT; DRUG DERIVATIVE; MONOCLONAL ANTIBODY; TAXOID; TUMOR MARKER; VINBLASTINE;

ADD ON THERAPY; ADULT; AGED; ALKALINE PHOSPHATASE BLOOD LEVEL; ALOPECIA; ANEMIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BILIRUBIN BLOOD LEVEL; BLOOD TRANSFUSION; BONE MARROW SUPPRESSION; BREAST CANCER; BREAST METASTASIS; CANCER CHEMOTHERAPY; CANCER COMBINATION CHEMOTHERAPY; CANCER GROWTH; CANCER PATIENT; CANCER SURVIVAL; CARDIOMYOPATHY; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DISEASE COURSE; DRUG DOSE REDUCTION; DRUG DOSE REGIMEN; DRUG FATALITY; DRUG SAFETY; DRUG WITHDRAWAL; FATIGUE; FEASIBILITY STUDY; FEBRILE NEUTROPENIA; FEMALE; FLUID RETENTION; FLUORESCENCE IN SITU HYBRIDIZATION; FOLLOW UP; HEART EJECTION FRACTION; HEART PALPITATION; HUMAN; HYPERGLYCEMIA; IMMUNOHISTOCHEMISTRY; LACRIMATION DISORDER; LIVER FUNCTION TEST; LOADING DRUG DOSE; MAJOR CLINICAL STUDY; MUCOSA INFLAMMATION; MULTIPLE CYCLE TREATMENT; MYALGIA; NAUSEA; NEUTROPENIA; ONCOGENE NEU; OVERALL SURVIVAL; PAIN; PERIPHERAL NEUROPATHY; PHASE 2 CLINICAL TRIAL; PNEUMONIA; PROGRESSION FREE SURVIVAL; RECOMMENDED DRUG DOSE; RESPIRATORY DISTRESS; SIDE EFFECT; STOMATITIS; SURVIVAL TIME; THORAX PAIN; THROMBOCYTOPENIA; TREATMENT DURATION; TREATMENT RESPONSE; VOMITING; BREAST TUMOR; METABOLISM; MIDDLE AGED; PATHOLOGY; PROGNOSIS; SURVIVAL RATE; TREATMENT OUTCOME;

ADULT; AGED; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; FEASIBILITY STUDIES; FEMALE; HUMANS; IN SITU HYBRIDIZATION, FLUORESCENCE; MIDDLE AGED; PROGNOSIS; RECEPTOR, ERBB-2; SURVIVAL RATE; TAXOIDS; TREATMENT OUTCOME; TUMOR MARKERS, BIOLOGICAL; VINBLASTINE;

EID: 65649133875     PISSN: 15268209     EISSN: None     Source Type: Journal    
DOI: 10.3816/CBC.2009.n.004     Document Type: Article

References (18)

1. Jacobs TW, Gown AM, Yaziji H, et al. Comparison of fluorescence in situ hybridization and immunohistochemistry for the evaluation of HER-2/neu in breast cancer. J Clin Oncol 1999; 17:1974-82.
2. Vogel CL, Cobleigh MA, Tripathy D, et al. Efficacy and safety of trastuzumab as a single agent in first-line treatment of HER2-overexpressing metastatic breast cancer. J Clin Oncol 2002; 20:719-26
3. Mohsin SK, Weiss HL, Gutierrez MC, et al. Neoadjuvant trastuzumab induces apoptosis in primary breast cancers. J Clin Oncol 2005; 23:2460-8.
4. Pegram MD, Konecny GE, O'Callaghan C, et al. Rational combinations of trastuzumab with chemotherapeutic drugs used in the treatment of breast cancer. J Natl Cancer Inst 2004; 96:739-49.
5. Pietras RJ, Fendly BM, Chazin VR, et al. Antibody to HER-2/neu receptor blocks DNA repair after cisplatin in human breast and ovarian cancer cells. Oncogene 1994; 9:1829-38.
6. Slamon DJ, Leyland-Jones B, Shak S, et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med 2001; 344:783-92.
7. Chan A. A review of the use of trastuzumab (Herceptin) plus vinorelbine in metastatic breast cancer. Ann Oncol 2007; 18:1152-8.
8. Marty M, Cognetti F, Maraninchi D, et al. Randomized phase II trial of the efficacy and safety of trastuzumab combined with docetaxel in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer administered as first-line treatment: the M77001 study group. J Clin Oncol 2005; 23:4265-74.
9. Sato N, Sano M, Tabei T, et al. Combination docetaxel and trastuzumab treatment for patients with HER-2-overexpressing metastatic breast cancer: a multicenter, phase-II study. Breast Cancer 2006; 13:166-71.
10. Esteva FJ, Valero V, Booser D, et al. Phase II study of weekly docetaxel and trastuzumab for patients with HER-2-overexpressing metastatic breast cancer. J Clin Oncol 2002; 20:1800-8.
11. Tedesco KL, Thor AD, Johnson DH, et al. Docetaxel combined with trastuzumab is an active regimen in HER-2 3+ overexpressing and fluorescent in situ hybridization-positive metastatic breast cancer: a multi-institutional phase II trial. J Clin Oncol 2004; 22:1071-7.
12. World Health Organization. Handbook for Reporting Results of Cancer Treatment. WHO Offset publication No. 48. Geneva, 1979.
13. Burstein HJ, Harris LN, Marcom PK, et al. Trastuzumab and vinorelbine as firstline therapy for HER2-overexpressing metastatic breast cancer: multicenter phase II trial with clinical outcomes, analysis of serum tumor markers as predictive factors, and cardiac surveillance algorithm. J Clin Oncol 2003; 21:2889-95.
14. Burstein HJ, Keshaviah A, Baron AD, et al. Trastuzumab plus vinorelbine or taxane chemotherapy for HER2-overexpressing metastatic breast cancer: the trastuzumab and vinorelbine or taxane study. Cancer 2007; 110:965-72.
15. Jahanzeb M, Mortimer JE, Yunus F, et al. Phase II trial of weekly vinorelbine and trastuzumab as first-line therapy in patients with HER2(+) metastatic breast cancer. Oncologist 2002; 7:410-7.
16. Pegram MD, Pienkowski T, Northfelt DW, et al. Results of two open-label, multicenter phase II studies of docetaxel, platinum salts, and trastuzumab in HER2-positive advanced breast cancer. J Natl Cancer Inst 2004; 96:759-69.
17. Seidman AD, Fornier MN, Esteva FJ, et al. Weekly trastuzumab and paclitaxel therapy for metastatic breast cancer with analysis of efficacy by HER2 immunophenotype and gene amplification. J Clin Oncol 2001; 19:2587-95.
18. Robert N, Leyland-Jones B, Asmar L, et al. Randomized phase III study of trastuzumab, paclitaxel, and carboplatin compared with trastuzumab and paclitaxel in women with HER-2-overexpressing metastatic breast cancer. J Clin Oncol 2006; 24:2786-92.