François-Clément Bidard, Head of Center for Clinical Investigation, Inserm CIC-1428 at Inserm, shared a post on LinkedIn:
“Big news: NoLEEta has started, with a FPFV (first patient first visit) earlier today at Institute of Women’s Cancers / Institut Curie.
NoLEEta is an Unicancer-coordinated global non-inferiority phase 3 trial to demonstrate that patients with intermediate-risk ER+ HER2- eBC treated with ribociclib could be spared the dreaded chemotherapy side effects while ensuring similar survival outcomes.
N=3,902 pts are awaited in 8 countries:
– BR: LACOG – Latin American Cooperative Oncology Group (LACOG)
– CA: Canadian Cancer Trials Group – Oncology (CCTG)
– CH: Swiss Cancer Institute (SCI, ex-SAKK)
– ES: SOLTI cancer research (SOLTI)
– FR: Unicancer (UCBG) & ARCAGY-GINECO (GINECO)
– GE: German Breast Group (GBG)
– IT: Gruppo Italiano Mammella (GIM)
– NL: BOOG Study Center (BOOG)
Industry collaborators are Novartis and, for an ancillary study on CTC, the diagnostic company Menarini Silicon Biosystems.
Thanks to the many people involved in the conception, writing and approval of the trial: Dr José Sandoval and external experts who helped develop the protocol at the MCCR workshop (Dr Saskia Litière, Dr Matteo Lambertini, Elisabeth de Vries, Dr Lioe Fee De Geus-Oei), the Unicancer Breast Group, our partners at Novartis and huge kudos to Sandrine Marques (Unicancer) for her impressive operational work to launch the trial.
Today’s FPFV occured at the Saint Cloud site of Institut Curie, local PI: Dr Diana Bello Roufai. Thanks !
More posts featuring François-Clément Bidard on OncoDaily.
