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
Sponsor organisation
F. Hoffmann-La Roche Ltd
Eudract number
2022-500014-26
Clinicaltrials.gov Identifier
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