Multicentric, randomized phase III trial of two different adjuvant chemotherapy regimens plus three versus twelve months of trastuzumab in patients with HER2- positive breast cancer (Short-HER Trial; NCT00629278)

Valentina Guarneri, Antonio Frassoldati, Paolo Bruzzi, Roberto D'Amico, Maurizio Belfiglio, Annamaria Molino, Oscar Bertetto, Stefano Cascinu, Francesco Cognetti, Angelo Di Leo, Paolo Pronzato, Lucio Crinó, Biagio Agostara, Pierfranco Conte

Research output: Contribution to journalArticle

Abstract

Trastuzumab, a monoclonal antibody against the HER2 receptor, is currently approved as a part of adjuvant therapy for patients with HER2-overexpressing breast tumors. The Short-HER study is a phase III randomized, multicentric Italian trial aimed at testing the optimal duration of adjuvant trastuzumab. In this trial, 2500 patients with HER2-positive breast cancer will be randomized to receive the following: (arm A, long) 4 courses of anthracycline- based chemotherapy (doxorubicin/cyclophosphamide or epidoxorubicin/cyclophosphamide) followed by 4 courses of docetaxel or paclitaxel in combination with trastuzumab, followed by 14 additional courses of trastuzumab administered every 3 weeks (for a total of 18 3-weekly doses of trastuzumab); or (arm B, short) 3 courses of 3-weekly docetaxel in combination with weekly trastuzumab (for a total of 9 weekly doses of trastuzumab) followed by 3 courses of 5-fluorouracil/epirubicin/cyclophosphamide. The primary objective is disease-free survival.

Original languageEnglish
Pages (from-to)453-456
Number of pages4
JournalClinical Breast Cancer
Volume8
Issue number5
DOIs
Publication statusPublished - Oct 1 2008

Keywords

  • Adjuvant therapy
  • Cardiac toxicity
  • HER2
  • Trastuzumab duration

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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