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

Journal of Clinical Oncology

Volumn 23, Issue 19, 2005, Pages 4265-4274

  Marty, Michel ^a   Cognetti, Francesco ^b   Maraninchi, Dominique ^b   Snyder, Ray ^b   Mauriac, Louis ^b   Tubiana Hulin, Michèle ^b   Chan, Stephen ^b   Grimes, David ^b   Antón, Io ^b   Lluch, Ana ^b   Kennedy, John ^b   O'Byrne, Kenneth ^b   Conte, PierFranco ^b   Green, Michael ^b   Ward, Carol ^b   Mayne, Karen ^b   Extra, Jean Marc ^b  

^a SAINT LOUIS HOSPITAL   (France)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

ANTHRACYCLINE; ANTIBIOTIC AGENT; DOCETAXEL; DOXORUBICIN; EPIDERMAL GROWTH FACTOR RECEPTOR 2; GRANULOCYTE COLONY STIMULATING FACTOR; TRASTUZUMAB; ANTINEOPLASTIC AGENT; MONOCLONAL ANTIBODY; TAXOID;

ADJUVANT THERAPY; ADULT; AGED; ALOPECIA; ANEMIA; ANOREXIA; ARTHRALGIA; ARTICLE; ASTHENIA; BREAST CANCER; CANCER COMBINATION CHEMOTHERAPY; CANCER PATIENT; CANCER SURVIVAL; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DISEASE COURSE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; DRUG WITHDRAWAL; DYSPNEA; EPISTAXIS; ERYTHEMA; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; FEVER; HEADACHE; HEART FAILURE; HEART LEFT VENTRICLE EJECTION FRACTION; HUMAN; INJECTION SITE REACTION; LACRIMATION; LEUKOPENIA; LOADING DRUG DOSE; MAJOR CLINICAL STUDY; METASTASIS; MONOTHERAPY; MUCOSA INFLAMMATION; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MYALGIA; NAUSEA; NEUTROPENIA; OVERALL SURVIVAL; PARESTHESIA; PERIPHERAL EDEMA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RASH; SEPTICEMIA; SIDE EFFECT; STOMATITIS; TREATMENT FAILURE; TREATMENT RESPONSE; VOMITING; ADOLESCENT; BREAST TUMOR; CHEMICALLY INDUCED DISORDER; COMPARATIVE STUDY; DRUG SCREENING; METABOLISM; MIDDLE AGED;

ADOLESCENT; ADULT; AGED; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; DRUG EVALUATION; FEMALE; HUMANS; LEUKOPENIA; MIDDLE AGED; NEOPLASM METASTASIS; NEUTROPENIA; RECEPTOR, ERBB-2; TAXOIDS;

EID: 22344446208     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2005.04.173     Document Type: Article

References (31)

1. Hynes N, Stern DF: The biology of erbB-2/neu/HER-2 and its role in cancer. Biochim Biophys Acta 1198:165-184, 1994
2. Slamon DJ, Clark GM, Wong SG, et al: Human breast cancer: Correlation of relapse and survival with amplification of the HER-2/neu oncogene. Science 235:177-182, 1987
3. Slamon DJ, Godolphin W, Jones LA, et al: Studies of the HER-2/neu proto-oncogene in human breast and ovarian cancer. Science 244:707-712, 1989
4. 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 17:2639-2648, 1999
5. 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 20:719-726, 2002
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 344:783-792, 2001
7. Baselga J: Herceptin alone or in combination with chemotherapy in the treatment of HER2-positive metastatic breast cancer: Pivotal trials. Oncology 61:14-21, 2001 (suppl 2)
8. Krasinska L, Jassem J: Taxanes in the treatment of advanced breast cancer. Nowotwory J Oncol 53:176-184, 2003
9. Chan S, Friedrichs K, Noel D, et al: Prospective randomised trial of docetaxel versus doxorubicin in patients with metastatic breast cancer: The 303 Study Group. J Clin Oncol 17:2341-2354, 1999
10. 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 96:739-749, 2004
11. Kuzur M, Albain K, Huntington M, et al: A phase II trial of docetaxel and Herceptin in metastatic breast cancer patients overexpressing HER-2. Proc Am Soc Clin Oncol 19:131 a, 2000 (abstr 512)
12. Toi M, Sasaki Y, Tokuda Y, et al: Phase I/II study of trastuzumab (Herceptin) on pharmacokinetics and safety in combination with paclitaxel or docetaxel for metastatic breast cancer. Ann Oncol 13:51, 2002 (suppl 5; abstr 182P)
13. Bauer-Kosińska B, Lemanska I, Glogowska I, et al: Efficacy and toxicity of docetaxel or cisplatin chemotherapy in combination with trastuzumab in the treatment of patients with chemotherapy pre-treated HER-2/neu overexpressed metastatic breast cancer. Eur J Cancer 1:S141, 2003 (suppl 5; abstr 464)
14. Montemurro F, Choa G, Faggiuolo R, et al: Safety and activity of docetaxel and trastuzumab in HER2 overexpressing breast cancer: A pilot phase II study. Am J Clin Oncol 26:95-97, 2003
15. Tabei T, Kimura M, Sano M, et al: Multicenter phase II trial of three-weekly docetaxel and weekly trastuzumab in HER2-overexpressing metastatic breast cancer patients: Japan East Cancer Center Breast Cancer Consortium (JECBC 01 trial). Eur J Cancer 2:131, 2004 (suppl 3; abstr 258)
16. Raab G, Brugger W, Harbeck N, et al: Multicenter randomized phase II study of docetaxel (Doc) given q3w vs q1w plus trastuzumab (Tra) as first line therapy for HER2 overexpressing adjuvant anthracycline pretreated metastatic breast cancer (MBC). Breast Cancer Res Treat 76:S114, 2002 (suppl 1; abstr 443)
17. Raff JP, Rajdev L, Malik U, et al: Phase II study of weekly docetaxel alone or in combination with trastuzumab in patients with metastatic breast cancer. Clin Breast Cancer 4:420-427, 2004
18. HER2 monoclonal antibody (Herceptin) plus docetaxel in patients with metastatic breast cancer: A pilot study. Anticancer Res 21:1301-1305, 2001
19. 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 20:1800-1808, 2002
20. Schwartz GH, Steis R, Mathew L: Patients with MBC prospectively selected by FISH derive clinical benefit from first-line treatment with Herceptin plus a taxane. Breast Cancer Res Treat 76:S111, 2002 (suppl 1; abstr 429)
21. Takao S, Kohno N, Miyashita M, et al: Weekly docetaxel and trastuzumab for her2-overexpressing metastatic breast cancer: Efficacy and correlation with biological markers in a phase II, multicenter study. Eur J Cancer 2:137, 2004 (suppl 3; abstr 280)
22. 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 22:1071-1077, 2004
23. Cook-Bruns N: Retrospective analysis of the safety of Herceptin immunotherapy in metastatic breast cancer. Oncology 61:58-66, 2001 (suppl 2)
24. Burstein HJ, Kuter I, Campos SM, et al: Clinical activity of trastuzumab and vinorelbine in women with HER2-overexpressing metastatic breast cancer. J Clin Oncol 19:2722-2730, 2001
25. 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 7:410-417, 2002
26. Seidman AD, Fornier MN, Esteva FJ, et al: Weekly trastuzumab and paclitaxel therapy for metastatic breast cancer with analysis of efficacy and by HER2 immunophenotype and gene amplification. J Clin Oncol 19:2587-2595, 2001
27. Thomssen CH, Eidtmann H, Untch M, et al: Cardiac safety of epirubicin/cyclophosphamide (EC) alone and in combination with Herceptin in women with metastatic breast cancer (MBC). Breast Cancer Res Treat 76:5111, 2002 (suppl 1; abstr 430)
28. Theodoulou M, Campos SM, Batist G, et al: TLC D99 (D, Myocet) and Herceptin (H) is safe in advanced breast cancer (ABC): Final cardiac safety and efficacy analysis. Proc Am Soc Clin Oncol 21:55a, 2002 (abstr 216)
29. Baselga J, Climent MA, Lluch A, et al: Results of a phase II study of liposomal doxorubicin (Myocet) in combination with weekly paclitaxel and trastuzumab (Herceptin) in patients with HER2-positive locally advanced or metastatic breast cancer (LA/MBC). Eur J Cancer 2:132, 2004 (suppl 3; abstr 262)
30. Marty M, Baselga J, Gatzemeier U, et al: Pooled analysis of six trials of trastuzumab (Herceptin): Exploratory analysis of changes in left ventricular ejection fraction (LVEF) as a surrogate for clinical cardiac events. Breast Cancer Res Treat 82:S48, 2003 (abstr 218)
31. Buzdar AU, Hunt K, Smith T, et al: Significantly higher pathological complete remission (PCR) rate following neoadjuvant therapy with trastuzumab [Herceptin (H)], paclitaxel (P), and anthracycime-containing chemotherapy (CT): Initial results of a randomized trial in operable breast cancer (BC) with HER/2 positive disease. Proc Am Soc Clin Oncol 23:7, 2004 (abstr 520)