Detail of the clinical trial
| Title of the trial | A randomized, multicenter, double-blind phase 3 study of SAR439859 plus palbociclib versus letrozole plus palbociclib for the treatment of patients with ER (+), HER2 (-) breast cancer who have not received prior systemic anti-cancer treatment for advanced disease |
|---|---|
| EudraCT number | 2020-001824-33 |
| Protocol number | EFC15935 |
| Sponsor | Sanofi-Aventis Recherche & Développement, 1 Avenue Pierre Brossolette, 913 80 Chilly-Mazarin, France |
| Indications | Oncology |
| Diagnosis | breast cancer |
| Population in clinical trial |
Adults (18-65 years) Elderly ( > 65 years) Male Female Patients |
| Year of receiving the request to Institute (SÚKL) | 2020 |
| Date of approval by Institute (SÚKL) | 19.10.2020 |
| Date of approval by EC | 19.11.2020 |
| Date of initiation CT in ČR | 23.2.2021 |
| Date of ending CT in ČR | 10.3.2023 |
| Notice | |
| Sites |
Multiscan, s.r.o.,Onkologické a radiologické centrum,Kyjevská 44,Pardubice,530 03 (discontinued) Všeobecná fakultní nemocnice v Praze,Onkologická klinika VFN a 1.LF UK,U Nemocnice 499/2,Praha 2,128 08 Masarykův onkologický ústav, Klinika komplexní onkologické péče,Žlutý kopec 7,Brno,656 53 FN Thomayerova , Onkologická klinika 1.LFUK a FTN (discontinued) FN v Motole, Onkologická klinika 2.LF UK a FN Motol (discontinued) |
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