A phase I/II trial of trastuzumab plus erlotinib in metastatic HER2-positive breast cancer: A dual ErbB targeted approach

Clinical Breast Cancer

Volumn 9, Issue 1, 2009, Pages 16-22

  Britten, Carolyn ^a   Finn, Richard ^a   Bosserman, Linda ^a   Wong, Steven ^a   Press, Michael ^b   Malik, Mubashira ^c   Lum, Bert ^c   Slamon, Dennis ^a  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

^c GENENTECH INC   (United States)

Author keywords

Dose escalation; Epidermal growth factor receptor; Pharmacokinetics

Indexed keywords

CARBOPLATIN; DOCETAXEL; DOXORUBICIN; EPIDERMAL GROWTH FACTOR RECEPTOR; ERLOTINIB; TRASTUZUMAB; ANTINEOPLASTIC AGENT; EPIDERMAL GROWTH FACTOR RECEPTOR 2; MONOCLONAL ANTIBODY; QUINAZOLINE DERIVATIVE; TUMOR MARKER;

ADJUVANT THERAPY; ADULT; AGED; ALOPECIA; AMINOTRANSFERASE BLOOD LEVEL; ANEMIA; ANOREXIA; ARTICLE; BRAIN METASTASIS; BREAST CANCER; BREAST METASTASIS; CANCER CHEMOTHERAPY; CANCER COMBINATION CHEMOTHERAPY; CARDIOTOXICITY; CLINICAL ARTICLE; CLINICAL TRIAL; CONGESTIVE HEART FAILURE; CONTROL GROUP; CONTROLLED STUDY; DIARRHEA; DISEASE COURSE; DRUG BLOOD LEVEL; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG HALF LIFE; DRUG TOLERABILITY; DRUG WITHDRAWAL; DRY SKIN; DYSGEUSIA; DYSPEPSIA; ENZYME LINKED IMMUNOSORBENT ASSAY; EPISTAXIS; FATIGUE; FEMALE; FEVER; HEADACHE; HEART LEFT VENTRICLE EJECTION FRACTION; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; HUMAN TISSUE; NAUSEA; NEUTROPENIA; ONCOGENE NEU; PARONYCHIA; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PRURITUS; RASH; RECOMMENDED DRUG DOSE; SIDE EFFECT; STEM CELL TRANSPLANTATION; STOMATITIS; THROMBOCYTOPENIA; TREATMENT DURATION; TREATMENT RESPONSE; VISUAL IMPAIRMENT; VOMITING; BREAST TUMOR; DOSE RESPONSE; MAXIMUM TOLERATED DOSE; METABOLISM; MIDDLE AGED; PATHOLOGY; PROGNOSIS; SURVIVAL RATE; TISSUE DISTRIBUTION; TREATMENT OUTCOME;

ADULT; AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HUMANS; MAXIMUM TOLERATED DOSE; MIDDLE AGED; PROGNOSIS; QUINAZOLINES; RECEPTOR, ERBB-2; SURVIVAL RATE; TISSUE DISTRIBUTION; TREATMENT OUTCOME; TUMOR MARKERS, BIOLOGICAL;

EID: 65649115021     PISSN: 15268209     EISSN: None     Source Type: Journal    
DOI: 10.3816/CBC.2009.n.003     Document Type: Article

References (25)

1. 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.
2. Piccart-Gebhart MJ, Procter M, Leyland-Jones B, et al. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med 2005; 353:1659-72.
3. Romond EH, Perez EA, Bryant J, et al. Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med 2005; 353:1673-84.
4. Slamon D, Eiermann W, Robert N, et al. BCIRG 006: 2nd interim analysis phase III trial comparing doxorubicin and cyclophosphamide followed by docetaxel with doxorubicin and cyclophosphamide followed by docetaxel and trastuzumab with docetaxel, carboplatin and trastuzumab in HER2 positiv? early breast cancer patients. Breast Cancer Res Treat 2006; 100(suppl 1):(Abstract 52).
5. Smith I, Procter M, Gelber RD, et al. 2-year follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer: a randomized controlled trial. Lancet 2007; 369:29-36.
6. Yarden Y, Sliwkowski MX. Untangling the ErbB signaling network. Nat Rev Mol Cell Biol 2001; 2:127-37.
7. Cho HS, Mason K, Ramyar KX, et al. Structure of the extracellular region of HER2 alone and in complex with the Herceptin Fab. Nature 2003; 421:756-60.
8. Garrett TP, McKern NM, Lou M, et al. The crystal structure of a truncated ErbB2 ectodomain reveals an active conformation, poised to interact with other ErbB receptors. Mol Cell 2003; 11:495-505.
9. Citri A, Skaria KB, Yarden Y. The deaf and the dumb: the biology of ErbB-2 and ErbB-3. Exp Cell Res 2003; 284:54-65.
10. Finn RS, Wilson CA, Sanders J, et al. Targeting the epidermal growth factor receptor and HER-2 with OSI-774 and trastuzumab, respectively, in HER-2 overexpressing human breast cancer cell lines results in a therapeutic advantage in vitro. Proc Am Soc Clin Oncol 2003; 22:235 (Abstract 940).
11. Moasser MM, Basso A, Averbuch SD, et al. The tyrosine kinase inhibitor ZD1839 ("Iressa") inhibits HER2-driven signaling and suppresses the growth of HER2-overexpressing tumor cells. Cancer Res 2001; 61:7184-8.
12. Normanno N, Campiglio M, De LA, et al. Cooperative inhibitor effect of ZD1839 (Iressa) in combination with trastuzumab (Herceptin) on human breast cancer cell growth. Ann Oncol 2002; 13:65-72.
13. Moulder SL, Yakes FM, Muthuswamy SK, et al. Epidermal growth factor receptor (HER1) tyrosine kinase inhibitor ZD 1839 (Iressa) inhibitrs HER2/neu (erbB2)-overexpressing breast cancer cells in vitro and in vivo. Cancer Res 2001; 61:8887-95.
14. Ritter CA, Perez-Torres M, Rinehart C, et al. Human breast cancer cells selected for resistance to trastuzumab in vivo overexpress epidermal growth factor receptor and ErbB ligands and remain dependent on the ErbB receptor network. Clin Cancer Res 2007; 13:4909-19.
15. Geyer CE, Forster J, Lindquist D, et al. Lapatinib plus capecitabine for HER2-positive advanced breast cancer. N Engl J Med 2006; 355:2733-43.
16. Pegram M, Chan D, Dichmann RA, et al. Phase II combined biological therapy targeting the HER2 proto-oncogene and the vascular endothelial growth factor using trastuzumab and bevacizumab as first line treatment of HER2-amplified breast cancer. Breast Cancer Res Treat 2006; 100(suppl 1):(Abstract 301).
17. Miller AB, Hoogstraten B, Staquet M, et al. Reporting results of cancer treatment. Cancer 1981; 47:207-14.
18. Zhao M, He P, Rudek MA, et al. Specific method for determination of OSI-774 and its metabolite OSI-420 in human plasma by using liquid chromatography-tandem mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci 2003; 793:413-20.
19. Lu JF, Eppler SM, Wolf J, et al. Clinical pharmacokinetics of erlotinib in patients with solid tumors and exposure-safety relationship in patients with non-small cell lung cancer. Clin Pharmacol Ther 2006; 80:136-45.
20. Bruno R, Washington CB, Lu JF, et al. Population pharmacokinetics of trastuzumab in patients with HER2+ metastatic breast cancer. Cancer Chemother Pharmacol 2005; 56:361-9.
21. Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials 1989; 10:1-10.
22. Vogel CL, Cobleigh MA, Tripathy D, et al. Efficacy and safety of trastuzumab as a single agent in first-line treatment of HER2-overexpressing met?static breast cancer. J Clin Oncol 2002; 20:719-26.
23. Perez-Soler R, Chachoua A, Hammond LA, et al. Determinants of tumor response and survival with erlotinib in patients with non-small-cell lung cancer. J Clin Oncol 2004; 22:3238-47.
24. Cobleigh MA, Vogel CL, Tripathy D, et al. 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 1999; 17:2639-48.
25. Arteaga CL, O'Neill A, Moulder SL, et al. A phase I-II study of combined blockade of the ErbB receptor network with trastuzumab and gefitinib in patients with HER2 (ErbB2)-overexpressing metastatic breast cancer. Clin Cancer Res 2008; 14:6277-83.