Randomized phase III trial of trastuzumab monotherapy followed by trastuzumab plus docetaxel versus trastuzumab plus docetaxel as first-line therapy in patients with HER2-positive metastatic breast cancer: The JO17360 Trial Group

Breast Cancer Research and Treatment

Volumn 119, Issue 1, 2010, Pages 127-136

  Inoue, Kenichi ^a   Nakagami, Kazuhiko ^b   Mizutani, Mitsuhiro ^c   Hozumi, Yasuo ^d   Fujiwara, Yasuhiro ^e   Masuda, Norikazu ^f   Tsukamoto, Fumine ^g   Saito, Mitsue ^h   Miura, Shigeto ⁱ   Eguchi, Kenji ^j   Shinkai, Tetsu ^k   Ando, Masashi ^e   Watanabe, Toru ^l   Masuda, Noriyuki ^m   Ohashi, Yasuo ⁿ   Sano, Muneaki ^o   Noguchi, Shinzaburo ^p  

^a SAITAMA CANCER CENTER   (Japan)

^b SHIZUOKA GENERAL HOSPITAL   (Japan)

^c Mikawa Breast Cancer Clinic   (Japan)

^d JICHI MEDICAL UNIVERSITY   (Japan)

^e NATIONAL CANCER CENTER   (Japan)

^f OSAKA NATIONAL HOSPITAL   (Japan)

^g OSAKA KOSEI NENKIN HOSPITAL   (Japan)

^h JUNTENDO UNIVERSITY   (Japan)

ⁱ Kamiiida Daiichi General Hospital   (Japan)

^j TEIKYO UNIVERSITY   (Japan)

^k NATIONAL HOSPITAL ORGANIZATION SHIKOKU CANCER CENTER   (Japan)

^l Hamamatsu City Med Ctr Devmtl M   (Japan)

^m KITASATO UNIVERSITY   (Japan)

ⁿ UNIVERSITY OF TOKYO   (Japan)

^o Niigata Breast Exam Center   (Japan)

^p OSAKA UNIVERSITY   (Japan)

more..

Author keywords

Combination therapy; Docetaxel; First line therapy; Metastatic breast cancer; Trastuzumab

Indexed keywords

DOCETAXEL; EPIDERMAL GROWTH FACTOR RECEPTOR 2; TRASTUZUMAB;

ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANOREXIA; ARTICLE; BREAST CANCER; BREAST METASTASIS; CANCER CHEMOTHERAPY; CANCER COMBINATION CHEMOTHERAPY; CANCER STAGING; CANCER SURVIVAL; CLINICAL TRIAL; CONGESTIVE HEART FAILURE; CONSTIPATION; CONTROL GROUP; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE COURSE; DRUG EFFICACY; DRUG SAFETY; DRUG TREATMENT FAILURE; DRUG WITHDRAWAL; EDEMA; ERYTHROCYTE COUNT; FEBRILE NEUTROPENIA; FEMALE; HEART LEFT VENTRICLE EJECTION FRACTION; HEMOGLOBIN BLOOD LEVEL; HUMAN; HYPERTENSION; LEUKOCYTE COUNT; LEUKOPENIA; LOADING DRUG DOSE; MAJOR CLINICAL STUDY; MONOTHERAPY; MULTICENTER STUDY; NEUTROPENIA; NEUTROPHIL COUNT; OVERALL SURVIVAL; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SYNCOPE; TREATMENT RESPONSE;

ADULT; AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; DISEASE PROGRESSION; DISEASE-FREE SURVIVAL; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; MIDDLE AGED; NEOPLASM METASTASIS; PROPORTIONAL HAZARDS MODELS; RECEPTOR, ERBB-2; TAXOIDS;

EID: 72449139053     PISSN: 01676806     EISSN: 15737217     Source Type: Journal    
DOI: 10.1007/s10549-009-0498-7     Document Type: Article

References (17)

1. GN Hortobagyi 1998 Treatment of breast cancer N Engl J Med 339 974 984 10.1056/NEJM199810013391407 1:CAS:528:DyaK1cXmslCitrY%3D 9753714 (Pubitemid 28455101)
2. MJ Piccart 2001 Proposed treatment guidelines for HER2-positive metastatic breast cancer in Europe Ann Oncol 12 Suppl.1 S89 S94 10.1023/A:1011133908093 11521728
3. NCCN Clinical Practice Guidelines in Oncology version 1 (2009) Breast cancer. http://www.nccn.org/professionals/physician-gls/PDF/breast.pdf
4. DJ Slamon B Leyland-Jones S Shak, et al. 2001 Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2 N Engl J Med 344 783 792 10.1056/NEJM200103153441101 1:CAS:528: DC%2BD3MXisVGktrc%3D 11248153 (Pubitemid 32222155)
5. M Marty F Cognetti D Maraninchi, et al. 2005 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 23 4265 4274 10.1200/JCO.2005.04.173 1:CAS:528:DC%2BD2MXms12gs70%3D 15911866 (Pubitemid 46207001)
6. CL Vogel MA Cobleigh D Tripathy, et al. 2002 Efficacy and safety of trastuzumab as a single agent in first-line treatment of HER2-overexpressing metastatic breast cancer J Clin Oncol 20 719 726 10.1200/JCO.20.3.719 1:CAS:528:DC%2BD38XhsVGmt7o%3D 11821453 (Pubitemid 34111379)
7. G Fountzilas E Razis D Tsavdaridis, et al. 2003 Continuation of trastuzumab beyond disease progression is feasible and safe in patients with metastatic breast cancer: a retrospective analysis of 80 cases by the Hellenic cooperative oncology group Clin Breast Cancer 4 120 125 10.3816/CBC.2003.n.017 1:CAS:528:DC%2BD3sXmt1OlsrY%3D 12864940
8. KA Gelmon J Mackey S Verma, et al. 2004 Use of trastuzumab beyond disease progression: observations from a retrospective review of case histories Clin Breast Cancer 5 52 58 10.3816/CBC.2004.n.010 1:CAS:528:DC%2BD2cXltFygsbk%3D 15140285
9. EC Antoine JM Extra A Vincent-Salomon, et al. 2007 Multiple lines of trastuzumab provide a survival benefit for women with metastatic breast cancer: results from the Hermine cohort study [abstract] Eur J Cancer 5 suppl 213 Abstract 2099
10. J Mackey KA Gelmon S Verma, et al. 2002 Continued use of Herceptin after disease progression in women with HER2-positive (HER2+) metastatic breast cancer (MBC): results from a retrospective analysis of 105 cases [abstract] J Clin Oncol 21 52a Abstract 207
11. G Von Minckwitz C Zielinski E Maarteense, et al. 2008 Capecitabine vs. capecitabine + trastuzumab in patients with HER2-positive metastatic breast cancer progressing during trastuzumab treatment: the TBP phase III study (GBG 26/BIG 3-05) [abstract] J Clin Oncol 26 suppl 47s Abstract 1025
12. J O'Shaughnessy KL Blackwell H Burstein, et al. 2008 A randomized study of lapatinib alone or in combination with trastuzumab in heavily pretreated HER2+ metastatic breast cancer progressing on trastuzumab therapy [abstract] J Clin Oncol 26 suppl 44s Abstract 1015
13. P Therasse SG Arbuck EA Eisenhauer, et al. 2000 New guidelines to evaluate the response to treatment in solid tumors. European organization for research and treatment of cancer, National cancer institute of the United States, National cancer institute of Canada J Natl Cancer Inst 92 205 216 10.1093/jnci/92.3.205 1:STN:280:DC%2BD3c7it1Gitg%3D%3D 10655437
14. M Bontenbal C Seynaeve J Stouthard, et al. 2008 Randomized study comparing efficacy/toxicity of monotherapy trastuzumab followed by monotherapy docetaxel at progression, and combination trastuzumab/docetaxel as first-line chemotherapy in HER2-neu positive, metastatic breast cancer (MBC) (HERTAX study) [abstract] J Clin Oncol 26 suppl 44s Abstract 1014
15. J Baselga 2001 Herceptin alone or in combination with chemotherapy in the treatment of HER2-positive metastatic breast cancer: pivotal trial Oncology 61 suppl 2 14 21 10.1159/000055397 1:CAS:528:DC%2BD3MXovFWjsL0%3D 11694783
16. D Tripathy D Slamon B Leyland-Jones, et al. 2000 Treatment beyond progression in the Herceptin pivotal combination chemotherapy trial [abstract] Breast Cancer Res Treat 64 32 Abstract 25
17. K Bullock K Blackwell 2008 Clinical efficacy of taxane-trastuzumab combination regimens for HER-2-positive metastatic breast cancer Oncologist 13 515 525 10.1634/theoncologist.2007-0204 1:CAS:528:DC%2BD1cXotFait7o%3D 18515736 (Pubitemid 351872869)