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Originally published as JCO Early Release 10.1200/JCO.2005.04.173 on May 23 2005

Journal of Clinical Oncology, Vol 23, No 19 (July 1), 2005: pp. 4265-4274
© 2005 American Society of Clinical Oncology.
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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

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

From the Institut Gustave-Roussy, Villejuif; Institut Paoli Calmettes, Marseille; Institut Bergonié, Bordeaux; Centre Rene Huguenin, Saint-Cloud; Institut Curie, Paris, France; Regina Elena Cancer Institute, Rome; University Hospital, Modena, Italy; St Vincent’s Hospital, Fitzroy; Wesley Medical Centre, Auchenflour; Royal Melbourne Hospital, Melbourne, Australia; Nottingham City Hospital, Nottingham; Department of Oncology, Leicester Royal Infirmary, Leicester; Roche Products Limited, Welwyn Garden City, United Kingdom; Hospital Miguel Servet, Zaragoza, Spain; Hospital Clinico Universitaire, Valencia, Spain; St James Hospital, Dublin, Ireland; and F. Hoffmann-La Roche Ltd, Basel, Switzerland

Address reprint requests to Michel Marty, MD, PhD, Innovative Therapeutics, Hôpital Saint Louis, 1 avenue Claude Vellefaux, 75010 Paris, France; e-mail: memarty{at}free.fr

PURPOSE: This randomized, multicenter trial compared first-line trastuzumab plus docetaxel versus docetaxel alone in patients with human epidermal growth factor receptor 2 (HER2) –positive metastatic breast cancer (MBC).

PATIENTS AND METHODS: Patients were randomly assigned to six cycles of docetaxel 100 mg/m2 every 3 weeks, with or without trastuzumab 4 mg/kg loading dose followed by 2 mg/kg weekly until disease progression.

RESULTS: A total of 186 patients received at least one dose of the study drug. Trastuzumab plus docetaxel was significantly superior to docetaxel alone in terms of overall response rate (61% v 34%; P = .0002), overall survival (median, 31.2 v 22.7 months; P = .0325), time to disease progression (median, 11.7 v 6.1 months; P = .0001), time to treatment failure (median, 9.8 v 5.3 months; P = .0001), and duration of response (median, 11.7 v 5.7 months; P = .009). There was little difference in the number and severity of adverse events between the arms. Grade 3 to 4 neutropenia was seen more commonly with the combination (32%) than with docetaxel alone (22%), and there was a slightly higher incidence of febrile neutropenia in the combination arm (23% v 17%). One patient in the combination arm experienced symptomatic heart failure (1%). Another patient experienced symptomatic heart failure 5 months after discontinuation of trastuzumab because of disease progression, while being treated with an investigational anthracycline for 4 months.

CONCLUSION: Trastuzumab combined with docetaxel is superior to docetaxel alone as first-line treatment of patients with HER2-positive MBC in terms of overall survival, response rate, response duration, time to progression, and time to treatment failure, with little additional toxicity.

Authors’ disclosures of potential conflicts of interest are found at the end of this article.


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S Beslija, J Bonneterre, H Burstein, V Cocquyt, M Gnant, P Goodwin, V Heinemann, J Jassem, W. Kostler, M Krainer, et al.
Second consensus on medical treatment of metastatic breast cancer
Ann. Onc., February 1, 2007; 18(2): 215 - 225.
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 Clin. Cancer Res.Home page
A. U. Buzdar, V. Valero, N. K. Ibrahim, D. Francis, K. R. Broglio, R. L. Theriault, L. Pusztai, M. C. Green, S. E. Singletary, K. K. Hunt, et al.
Neoadjuvant Therapy with Paclitaxel followed by 5-Fluorouracil, Epirubicin, and Cyclophosphamide Chemotherapy and Concurrent Trastuzumab in Human Epidermal Growth Factor Receptor 2-Positive Operable Breast Cancer: An Update of the Initial Randomized Study Population and Data of Additional Patients Treated with the Same Regimen
Clin. Cancer Res., January 1, 2007; 13(1): 228 - 233.
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 JCOHome page
Z. Gabos, R. Sinha, J. Hanson, N. Chauhan, J. Hugh, J. R. Mackey, and B. Abdulkarim
Prognostic Significance of Human Epidermal Growth Factor Receptor Positivity for the Development of Brain Metastasis After Newly Diagnosed Breast Cancer
J. Clin. Oncol., December 20, 2006; 24(36): 5658 - 5663.
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 Clin. Cancer Res.Home page
F. Meric-Bernstam and M.-C. Hung
Advances in targeting human epidermal growth factor receptor-2 signaling for cancer therapy.
Clin. Cancer Res., November 1, 2006; 12(21): 6326 - 6330.
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 JCOHome page
V. Guarneri, D. J. Lenihan, V. Valero, J.-B. Durand, K. Broglio, K. R. Hess, L. B. Michaud, A. M. Gonzalez-Angulo, G. N. Hortobagyi, and F. J. Esteva
Long-Term Cardiac Tolerability of Trastuzumab in Metastatic Breast Cancer: The M.D. Anderson Cancer Center Experience
J. Clin. Oncol., September 1, 2006; 24(25): 4107 - 4115.
[Abstract] [Full Text] [PDF]

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 The OncologistHome page
A. M. Gonzalez-Angulo, G. N. Hortobagyi, and F. J. Esteva
Adjuvant Therapy with Trastuzumab for HER-2/neu-Positive Breast Cancer
Oncologist, September 1, 2006; 11(8): 857 - 867.
[Abstract] [Full Text] [PDF]

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 The OncologistHome page
D. Cameron, R. Bell, M. Aapro, and C. Zielinski
What Are the Current Standards of Care and Recent Developments in the Management of Breast Cancer?
Oncologist, September 1, 2006; 11(suppl_1): 1 - 3.
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 The OncologistHome page
J. Baselga, E. A. Perez, T. Pienkowski, and R. Bell
Adjuvant Trastuzumab: A Milestone in the Treatment of HER-2-Positive Early Breast Cancer
Oncologist, September 1, 2006; 11(suppl_1): 4 - 12.
[Abstract] [Full Text] [PDF]

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 The OncologistHome page
C. Jackisch
HER-2-Positive Metastatic Breast Cancer: Optimizing Trastuzumab-Based Therapy
Oncologist, September 1, 2006; 11(suppl_1): 34 - 41.
[Abstract] [Full Text] [PDF]

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 CA Cancer J ClinHome page
R. M. Sharkey and D. M. Goldenberg
Targeted Therapy of Cancer: New Prospects for Antibodies and Immunoconjugates
CA Cancer J Clin, July 1, 2006; 56(4): 226 - 243.
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 The OncologistHome page
G. Ferretti, P. Papaldo, A. Fabi, P. Carlini, A. Felici, and F. Cognetti
Adjuvant Trastuzumab with Docetaxel or Vinorelbine for HER-2-Positive Breast Cancer
Oncologist, July 1, 2006; 11(7): 853 - 854.
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 Cancer Res.Home page
D. Srinivasan and R. Plattner
Activation of Abl Tyrosine Kinases Promotes Invasion of Aggressive Breast Cancer Cells
Cancer Res., June 1, 2006; 66(11): 5648 - 5655.
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P. J. Perik, M. N. Lub-De Hooge, J. A. Gietema, W. T.A. van der Graaf, M. A. de Korte, S. Jonkman, J. G.W. Kosterink, D. J. van Veldhuisen, D. T. Sleijfer, P. L. Jager, et al.
Indium-111-Labeled Trastuzumab Scintigraphy in Patients With Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer
J. Clin. Oncol., May 20, 2006; 24(15): 2276 - 2282.
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 Ann OncolHome page
P. Papaldo, A. Fabi, G. Ferretti, M. Mottolese, A. M. Cianciulli, B. Di Cocco, M. S. Pino, P. Carlini, S. Di Cosimo, I. Sacchi, et al.
A phase II study on metastatic breast cancer patients treated with weekly vinorelbine with or without trastuzumab according to HER2 expression: changing the natural history of HER2-positive disease
Ann. Onc., April 1, 2006; 17(4): 630 - 636.
[Abstract] [Full Text] [PDF]

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 The OncologistHome page
F. Montemurro, M. Donadio, M. Clavarezza, S. Redana, M. E. Jacomuzzi, G. Valabrega, S. Danese, G. Vietti-Ramus, A. Durando, M. Venturini, et al.
Outcome of Patients with HER2-Positive Advanced Breast Cancer Progressing During Trastuzumab-Based Therapy.
Oncologist, April 1, 2006; 11(4): 318 - 324.
[Abstract] [Full Text] [PDF]

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B. P. Coudert, L. Arnould, L. Moreau, P. Chollet, B. Weber, L. Vanlemmens, C. Molucon, N. Tubiana, S. Causeret, J.-L. Misset, et al.
Pre-operative systemic (neo-adjuvant) therapy with trastuzumab and docetaxel for HER2-overexpressing stage II or III breast cancer: results of a multicenter phase II trial
Ann. Onc., March 1, 2006; 17(3): 409 - 414.
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 NEJMHome page
H. Joensuu, P.-L. Kellokumpu-Lehtinen, P. Bono, T. Alanko, V. Kataja, R. Asola, T. Utriainen, R. Kokko, A. Hemminki, M. Tarkkanen, et al.
Adjuvant docetaxel or vinorelbine with or without trastuzumab for breast cancer.
N. Engl. J. Med., February 23, 2006; 354(8): 809 - 820.
[Abstract] [Full Text] [PDF]

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 CMAJHome page
S. Murray
Trastuzumab (Herceptin) and HER2-positive breast cancer
Can. Med. Assoc. J., January 3, 2006; 174(1): 36 - 37.
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 NEJMHome page
M. J. Piccart-Gebhart, M. Procter, B. Leyland-Jones, A. Goldhirsch, M. Untch, I. Smith, L. Gianni, J. Baselga, R. Bell, C. Jackisch, et al.
Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer.
N. Engl. J. Med., October 20, 2005; 353(16): 1659 - 1672.
[Abstract] [Full Text] [PDF]

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 NEJMHome page
G. N. Hortobagyi
Trastuzumab in the treatment of breast cancer.
N. Engl. J. Med., October 20, 2005; 353(16): 1734 - 1736.
[Full Text] [PDF]

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 The OncologistHome page
J. O'Shaughnessy
Extending Survival with Chemotherapy in Metastatic Breast Cancer
Oncologist, October 1, 2005; 10(suppl_3): 20 - 29.
[Abstract] [Full Text] [PDF]

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 JCOHome page
C. L. Vogel and E. Tan-Chiu
Trastuzumab Plus Chemotherapy: Convincing Survival Benefit or Not?
J. Clin. Oncol., July 1, 2005; 23(19): 4247 - 4250.
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