This article has been updated to add the word "selective" to the description of amcenestrant as a selective estrogen receptor degrader.
NEW YORK – Sanofi on Friday announced it is working with several international research groups to conduct the Phase III AMEERA-6 trial, comparing the safety and efficacy of its selective estrogen receptor degrader amcenestrant against tamoxifen in ER-positive breast cancer patients who cannot continue to receive adjuvant aromatase inhibitors.
Sanofi will collaborate with the Breast International Group (BIG), the European Organization for Research and Treatment of Cancer (EORTC), and the Alliance Foundation Trials (AFT) to conduct the global clinical trial.
The drugmaker will fund the AMEERA-6 trial and provide the drug for research. BIG will conduct the study within its global research network, EORTC will conduct data analysis and provide management oversight, and AFT will be in charge of conducting the study in the US. Sanofi will conduct the study in locations outside of these academic networks, and all four collaborators will develop the study protocol.
In developing amcenestrant, the researchers hope to advance another, perhaps more tolerable, adjuvant treatment option for ER-positive breast cancer patients. "Adjuvant therapy helps prevent and delay the progression of disease into the later setting," David Cameron, chair of the BIG executive board, said in a statement. "However, current adjuvant therapies, like aromatase inhibitors, can have side effects for some women, which may cause them to discontinue the medication prematurely."