Subcutaneous vs Intravenous Trastuzumab for Patients With ERBB2-Positive Early Breast Cancer: Final Analysis of the HannaH Phase 3 Randomized Clinical Trial.

ABSTRACT:

Importance

Confirmation of long-term comparability between subcutaneous and intravenous trastuzumab is essential.

Objective

To evaluate efficacy and safety of subcutaneous trastuzumab compared with that of intravenous trastuzumab for patients with ERBB2 (HER2)-positive early breast cancer after 6 years' follow-up in the HannaH (Enhanced Treatment With Neoadjuvant Herceptin) trial.

Design, setting, and participants

Open-label, prospective, multicenter, international, neoadjuvant-adjuvant, randomized, phase 3 noninferiority clinical trial (primary end points: pathologic complete response and serum trough concentration predose cycle 8) conducted for 596 patients with ERBB2-positive early breast cancer enrolled from October 19, 2009, to December 1, 2010.

Interventions<

SUBMITTER: Jackisch C 

PROVIDER: S-EPMC6512301 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature