Subcutaneous vs Intravenous Trastuzumab for Patients With ERBB2-Positive Early Breast Cancer: Final Analysis of the HannaH Phase 3 Randomized Clinical Trial
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F61989592%3A15110%2F19%3A73596403" target="_blank" >RIV/61989592:15110/19:73596403 - isvavai.cz</a>
Result on the web
<a href="https://jamanetwork.com/journals/jamaoncology/fullarticle/2730632" target="_blank" >https://jamanetwork.com/journals/jamaoncology/fullarticle/2730632</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1001/jamaoncol.2019.0339" target="_blank" >10.1001/jamaoncol.2019.0339</a>
Alternative languages
Result language
angličtina
Original language name
Subcutaneous vs Intravenous Trastuzumab for Patients With ERBB2-Positive Early Breast Cancer: Final Analysis of the HannaH Phase 3 Randomized Clinical Trial
Original language description
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: Eligible patients received 8 cycles of chemotherapy (4 cycles of docetaxel, 75 mg/m2, followed by 4 cycles of fluorouracil, 500 mg/m2, epirubicin, 75 mg/m2, and cyclophosphamide, 500 mg/m2) with either fixed-dose subcutaneous trastuzumab, 600 mg, or intravenous trastuzumab (loading dose, 8 mg/kg; maintenance dose, 6 mg/kg) every 3 weeks in the neoadjuvant setting.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30204 - Oncology
Result continuities
Project
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Continuities
I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace
Others
Publication year
2019
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
JAMA Oncology
ISSN
2374-2437
e-ISSN
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Volume of the periodical
5
Issue of the periodical within the volume
5
Country of publishing house
US - UNITED STATES
Number of pages
1
Pages from-to
622
UT code for WoS article
000467495600001
EID of the result in the Scopus database
2-s2.0-85064490409