Pathological complete response rates following different neoadjuvant chemotherapy regimens for operable breast cancer according to ER status, in two parallel, randomized phase II trials with an adaptive study design (ECTO II)

Breast Cancer Res Treat (2012) 132:843851 DOI 10.1007/s10549-011-1660-6

CLINICAL TRIAL

Pathological complete response rates following different neoadjuvant chemotherapy regimens for operable breast cancer according to ER status, in two parallel, randomized phase II trials with an adaptive study design (ECTO II)

Milvia Zambetti Mauro Mansutti Patricia Gomez Ana Lluch

Christian Dittrich Claudio Zamagni Eva Ciruelos Lorenzo Pavesi

Vladimir Semiglazov Elena De Benedictis Fernando Gaion Mario Bari

Paolo Morandi Pinuccia Valagussa Gianni Luca

Received: 16 February 2011 / Accepted: 24 June 2011 / Published online: 13 July 2011 Springer Science+Business Media, LLC. 2011

Abstract Sequential doxorubicin/paclitaxel (AT) followed by CMF treatment was shown to be an active neoadjuvant chemotherapy regimen in the rst European Cooperative Trial in Operable Breast Cancer (ECTO I trial). The aim of the current study (ECTO II) is to assess the complete pathological response (pCR) rate following three different anthracycline and taxane-containing neoadjuvant chemotherapy regimens, with or without capecitabine (X). Patients with operable, invasive breast cancer [2.0 cm in

diameter, were randomized to AT?CMF, AT?CMX or AC?TX regimens in two parallel, randomized, open-label, phase II trials (within a single study) in patients with estrogen receptor negative (ER-) and estrogen receptor positive (ER?) diseases, respectively. Exemestane was delivered concomitantly with neoadjuvant chemotherapy in ER? tumors. Achievement of pCR was more common in ER-than ER? women (45.3 vs. 10.4%). Capecitabine was only associated with a higher frequency of pCR in ER? patients receiving AT?CMX. Overall response rates (ORR) ranged

V. SemiglazovNN Petrov Research Institute of Oncology, St. Petersburg, Russian Federation

F. GaionOspedale Civile di Camposampiero, Camposampiero, Italy

M. BariPresidio Ospedaliero di Noale, Noale, Italy

P. MorandiOspedale S. Bortolo, Vicenza, Italy

P. ValagussaFondazione Michelangelo, Milan, Italy

Present Address:M. Zambetti G. Luca (&)

Fondazione Centro San Raffaele del Monte Tabor, Via Olgettina, 60, 20132 Milano, Italye-mail: [email protected]

Presented in part at the 2010 Breast Cancer Symposium, October 13, Suburban Washington, DC, USA.

M. Zambetti E. De Benedictis G. Luca

Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy

M. MansuttiOspedale Universitario Santa Maria della Misericordia, Udine, Italy

P. GomezHospital General Vall dHebron, Barcelona, Spain

A. LluchHospital Clnico Universitario de Valencia, Valencia, Spain

C. DittrichLBI-ACR & ACR-ITR VIEnna, Kaiser Franz Josef-Spital, Vienna, Austria

C. ZamagniOspedale Policlinico S.Orsola Malpighi, Bologna, Italy

E. CiruelosHospital Universitario 12 de Octubre, Madrid, Spain

L....