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A phase III, randomized, open-label study to compare pharmacokinetics, efficacy and safety of subcutaneous (SC) trastuzumab with intravenous (IV) trastuzumab administered in women with HER2 positive early breast cancer (EBC).

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Trial Profile

A phase III, randomized, open-label study to compare pharmacokinetics, efficacy and safety of subcutaneous (SC) trastuzumab with intravenous (IV) trastuzumab administered in women with HER2 positive early breast cancer (EBC).

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 20 Jan 2022

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At a glance

  • Drugs Trastuzumab (Primary) ; Trastuzumab (Primary) ; Cyclophosphamide; Docetaxel; Epirubicin; Fluorouracil
  • Indications Adenocarcinoma; Early breast cancer; HER2 positive breast cancer; Inflammatory breast cancer
  • Focus Pharmacokinetics; Registrational; Therapeutic Use
  • Acronyms HannaH
  • Sponsors Roche

Most Recent Events

  • 14 Dec 2019 Results of integrated retrospective analysis assessing risk of recurrence and death after neoadjuvant systemic therapy by using data from five studies (HannaH, NeoSphere, TRYPHAENA, BERENICE, KRISTINE) presented at the 42nd Annual San Antonio Breast Cancer Symposium.
  • 28 Feb 2019 Results presented in the Genentech media release.
  • 28 Feb 2019 According to the Genentech media release, based on the data from this study, the U.S. Food and Drug Administration has approved a subcutaneous injection of Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) for the treatment of HER2-positive early breast cancer in combination with chemotherapy and HER2-positive metastatic breast cancer in combination with paclitaxel or alone in people who have received one or more chemotherapy regimens for metastatic disease.

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