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Subcutaneous versus intravenous formulation of trastuzumab for HER2-positive early breast cancer: updated results from the phase III HannaH study

The result's identifiers

  • Result code in IS VaVaI

    <a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F61989592%3A15110%2F15%3A33155450" target="_blank" >RIV/61989592:15110/15:33155450 - isvavai.cz</a>

  • Result on the web

    <a href="http://dx.doi.org/10.1093/annonc/mdu524" target="_blank" >http://dx.doi.org/10.1093/annonc/mdu524</a>

  • DOI - Digital Object Identifier

    <a href="http://dx.doi.org/10.1093/annonc/mdu524" target="_blank" >10.1093/annonc/mdu524</a>

Alternative languages

  • Result language

    angličtina

  • Original language name

    Subcutaneous versus intravenous formulation of trastuzumab for HER2-positive early breast cancer: updated results from the phase III HannaH study

  • Original language description

    Background: HannaH (NCT00950300) was a phase III, randomized, international, open-label study that compared pharmacokinetics (PK), efficacy, and safety of two different trastuzumab formulations [subcutaneous (s. c.) and intravenous (i. v.)] in HER2-positive, operable, locally advanced, or inflammatory breast cancer in the neoadjuvant/adjuvant setting. The co-primary end points, to show noninferiority of s. c. versus i. v. trastuzumab in terms of serum concentration (Ctrough) and pathologic complete response (pCR) were met; safety profiles were comparable at 12 months' median follow-up. Secondary end points included safety and tolerability, PK profile, immunogenicity, and event-free survival (EFS). We now report updated safety and efficacy data after amedian follow-up of 20 months. Patients and methods: Patients (N = 596) were treated with eight cycles of neoadjuvant chemotherapy, administered concurrently with 3-weekly s. c. trastuzumab (fixed dose of 600 mg) or the standard weight-ba

  • Czech name

  • Czech description

Classification

  • Type

    J<sub>x</sub> - Unclassified - Peer-reviewed scientific article (Jimp, Jsc and Jost)

  • CEP classification

    FD - Oncology and haematology

  • OECD FORD branch

Result continuities

  • Project

  • Continuities

    I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Others

  • Publication year

    2015

  • Confidentiality

    S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Data specific for result type

  • Name of the periodical

    Annals of Oncology

  • ISSN

    0923-7534

  • e-ISSN

  • Volume of the periodical

    26

  • Issue of the periodical within the volume

    2

  • Country of publishing house

    GB - UNITED KINGDOM

  • Number of pages

    6

  • Pages from-to

    320-325

  • UT code for WoS article

  • EID of the result in the Scopus database