Phase II trial of vinorelbine and trastuzumab in patients with HER2-positive metastatic breast cancer. A prospective, open label, non-controlled, multicenter phase II trial (to investigate efficacy and safety of this combination chemotherapy)

Investigational New Drugs

Volumn 27, Issue 2, 2009, Pages 166-172

  Schilling, G ^a   Bruweleit, M ^a   Harbeck, N ^b   Thomssen, C ^a   Becker, K ^c   Hoffmann, R ^d   Villena, C ^e   Schutte M ^f   Hossfeld, D K ^a,c   Bokemeyer, C ^a   De Wit, M ^a,g  

^a UNIVERSITY MEDICAL CENTER HAMBURG EPPENDORF   (Germany)

^b TECHNICAL UNIVERSITY OF MUNICH   (Germany)

^c Onkologische Schwerpunktpraxis Lerchenfeld   (Germany)

^d Onkologische Praxis   (Germany)

^e Frauenklinik Stadtklinik Baden Baden ^*  (Germany)

^f Bethesda Krankenhaus   (Germany)

^g Vivantes Klinikum   (Germany)

Author keywords

Metastatic breast cancer; Phase II trial; Trastuzumab; Vinorelbine

Indexed keywords

EPIDERMAL GROWTH FACTOR RECEPTOR 2; NAVELBINE; TRASTUZUMAB; ANTINEOPLASTIC AGENT; DRUG DERIVATIVE; MONOCLONAL ANTIBODY; VINBLASTINE;

ADULT; ALOPECIA; ARTICLE; BLOOD TOXICITY; BREAST CANCER; CANCER REGRESSION; CARDIOTOXICITY; CLINICAL ARTICLE; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONSTIPATION; DIARRHEA; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FATIGUE; FEMALE; FLUORESCENCE IN SITU HYBRIDIZATION; HEART ARRHYTHMIA; HUMAN; HYPERSENSITIVITY REACTION; IMMUNOHISTOCHEMISTRY; INFECTION; METASTASIS; MOOD DISORDER; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; PAIN; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PROSPECTIVE STUDY; PROTEIN EXPRESSION; STOMATITIS; TREATMENT OUTCOME; TREATMENT RESPONSE; VOMITING; ADENOCARCINOMA; BREAST TUMOR; DISEASE FREE SURVIVAL; GENETICS; PATHOLOGY; PROTO ONCOGENE;

ADENOCARCINOMA; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; DISEASE-FREE SURVIVAL; FEMALE; GENES, ERBB-2; HUMANS; NEOPLASM METASTASIS; VINBLASTINE;

EID: 66949111527     PISSN: 01676997     EISSN: None     Source Type: Journal    
DOI: 10.1007/s10637-008-9166-8     Document Type: Article

References (24)

1. R Simon 1989 Optimal two-stage designs for phase II clinical trials Control Clin Trials 10 1 10 (Pubitemid 19099520)
2. MS Berger 1988 Correlation of c-erbB-2 gene amplification and protein expression in human breast carcinoma with nodal status and nuclear grading Cancer Res 48 5 1238 1243 (Pubitemid 18075540)
3. DJ Slamon 1987 Human breast cancer: correlation of relapse and survival with amplification of the HER-2/neu oncogene Science 235 4785 177 182 (Pubitemid 17231334)
4. DJ Slamon 1989 Studies of the HER-2/neu proto-oncogene in human breast and ovarian cancer Science 244 4905 707 712 (Pubitemid 19147683)
5. CL Vogel 2002 Efficacy and safety of trastuzumab as a single agent in first-line treatment of HER2-overexpressing metastatic breast cancer J Clin Oncol 20 3 719 726 (Pubitemid 34111379)
6. MA Cobleigh 1999 Multinational study of the efficacy and safety of humanized anti-HER2 monoclonal antibody in women who have HER2-overexpressing metastatic breast cancer that has progressed after chemotherapy for metastatic disease J Clin Oncol 17 9 2639 2648 (Pubitemid 29415219)
7. J Baselga 1999 Phase II study of weekly intravenous trastuzumab (Herceptin) in patients with HER2/neu-overexpressing metastatic breast cancer Semin Oncol 26 4 Suppl 12 78 83 (Pubitemid 29411436)
8. DJ Slamon 2001 Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2 N Engl J Med 344 11 783 792 (Pubitemid 32222155)
9. D Osoba 1999 Health-related quality of life in women with metastatic breast cancer treated with trastuzumab (Herceptin) Semin Oncol 26 4 Suppl 12 84 88 (Pubitemid 29411437)
10. MD Pegram 1999 Inhibitory effects of combinations of HER-2/neu antibody and chemotherapeutic agents used for treatment of human breast cancers Oncogene 18 13 2241 2251
11. MD Pegram 2004 Rational combinations of trastuzumab with chemotherapeutic drugs used in the treatment of breast cancer J Natl Cancer Inst 96 10 739 749 (Pubitemid 38771819)
12. RJ Pietras 1998 Remission of human breast cancer xenografts on therapy with humanized monoclonal antibody to HER-2 receptor and DNA-reactive drugs Oncogene 17 2235 2249 (Pubitemid 28515376)
13. L Gianni 1995 Paclitaxel in metastatic breast cancer: a trial of two doses by a 3-hour infusion in patients with disease recurrence after prior therapy with anthracyclines J Natl Cancer Inst 87 15 1169 1175
14. AD Seidman 1995 Phase II trial of paclitaxel by 3-hour infusion as initial and salvage chemotherapy for metastatic breast cancer J Clin Oncol 13 10 2575 2581
15. Y Suzuki 2003 Combination of trastuzumab and vinorelbine in metastatic breast cancer Jpn J Clin Oncol 33 10 514 517 (Pubitemid 43115244)
16. HJ Burstein 2003 Trastuzumab and vinorelbine as first-line therapy for HER2-overexpressing metastatic breast cancer: multicenter phase II trial with clinical outcomes, analysis of serum tumour markers as predictive factors, and cardiac surveillance algorithm J Clin Oncol 21 15 2889 2895 (Pubitemid 46621838)
17. EP Winer HJ Burstein 2001 New combinations with Herceptin in metastatic breast cancer Oncology 61 Suppl 2 50 57 (Pubitemid 33033425)
18. HJ Burstein 2007 Trastuzumab plus vinorelbine or taxane chemotherapy for HER2-overexpressing metastatic breast cancer: the trastuzumab and vinorelbin or taxane study Cancer 110 5 965 972 (Pubitemid 47312860)
19. Franquesa R, Centelles M, Villadiego K (2005) A multicenter study of trastuzumab (H) and vinorelbine (N) as first and second line therapy for patients with HER2-positive metastatic breast cancer (HER2+ MBC). ASCO Meeting Abstracts, 868
20. M Jahanzeb 2002 Phase II trial of weekly vinorelbine and trastuzumab as first-line therapy in patients with HER2(+) metastatic breast cancer Oncologist 7 5 410 417 (Pubitemid 35266133)
21. HJ Burstein 2001 Clinical activity of trastuzumab and vinorelbine in women with HER2-overexpressing metastatic breast cancer J Clin Oncol 19 10 2722 2730 (Pubitemid 32441378)
22. Porta V, Martin M, Gil M (2004) Evaluation of vinorelbine (N) and trastuzumab (H) as first line therapy for HER2-positive metastatic breast cancer (HER2+ MBC): impact on clinical response and cardiac function. ASCO Meeting Abstracts: 636
23. R Bartsch C Wenzel G Altorjai 2007 Results from an observational trial with oral vinorelbine and trastuzumab in advanced breast cancer Breast Cancer Res Treat 102 3 375 381 (Pubitemid 46474847)
24. C Catania M Medici E Magni 2007 Optimizing clinical care of patients with metastatic breast cancer: a new oral vinorelbine plus trastuzumab combination Ann Oncol 18 12 1969 1975 (Pubitemid 350286233)