WO43571-Giredestrant and Phesgo in breast cancer

  • Research type

    Research Study

  • Full title

    A PHASE III, RANDOMIZED, OPEN-LABEL STUDY EVALUATING THE EFFICACY AND SAFETY OF GIREDESTRANT IN COMBINATION WITH PHESGO VERSUS PHESGO AFTER INDUCTION THERAPY WITH PHESGO.TAXANE IN PATIENTS WITH PREVIOUSLY UNTREATED HER2-POSITIVE, ESTROGEN RECEPTOR-POSITIVE LOCALLY-ADVANCED OR METASTATIC BREAST CANCER

  • IRAS ID

    1003524

  • Contact name

    Parthiv Gadhiya

  • Contact email

    uk.dra@roche.com

  • Sponsor organisation

    F. Hoffmann-La Roche Ltd

  • Eudract number

    2022-500014-26

  • Clinicaltrials.gov Identifier

    NCT05296798

  • Research summary

    The purpose of this study is to test a new combination of drugs to find out if they decrease the chances of your breast cancer getting worse. One of the study drugs, Phesgo, attaches to HER2 on the cancer cell and stops the cell from being able to use HER2 to grow. Phesgo® (pertuzumab + trastuzumab) is already approved for use by patients who have been diagnosed with HER2-positive breast cancer. The other study drug, giredestrant, is a new experimental drug that is designed to block the cancer cell’s ability to use the sex hormone called oestrogen to grow. The combination of Phesgo and giredestrant is an experimental combination for the treatment of breast cancer that is both HER2-positive and ER-positive. This clinical trial is designed to find out whether the drugs Phesgo and giredestrant work better together than Phesgo by itself. This study will also compare the effects, good or bad, of Phesgo plus giredestrant versus Phesgo by itself on patients. The study will last approximately 7 years. Approximately 40 participants will take part in the study in the UK and 812 worldwide from 23 countries will take part in this study. \nThe study is sponsored by F. Hoffman La Roche\nResearch Summary; Version 1 and 21-March-2022;

  • REC name

    South Central - Oxford B Research Ethics Committee

  • REC reference

    22/SC/0141

  • Date of REC Opinion

    16 Jun 2022

  • REC opinion

    Further Information Favourable Opinion