Sanofi has partnered with academic cooperative groups for a Phase III clinical trial of amcenestrant as an adjuvant to treat patients with estrogen receptor-positive (ER+) breast cancer.
The company will initiate the global Phase III AMEERA-6 trial with the Breast International Group (BIG), the European Organization for Research and Treatment of Cancer (EORTC) and the Alliance Foundation Trials (AFT).
Amcenestrant is an oral selective oestrogen receptor degrader (SERD). It antagonizes and degrades the estrogen receptor (ER), in turn blocking the ER signalling pathway.
The Phase III trial will compare the safety and efficacy of amcenestrant to tamoxifen in women with ER+ breast cancer who have prematurely ended their adjuvant aromatase inhibitor (AI) therapy.
BIG Executive Board chairman David Cameron said: “Adjuvant therapy helps prevent and delay the progression of disease into the later setting. However, current adjuvant therapies, like AIs, can have side effects for some women, which may cause them to discontinue the medication prematurely.
“Amcenestrant may be a potential option for women in this setting and we look forward to working with Sanofi, EORTC and AFT to investigate this further.”
Sanofi stated that many patients have disease recurrence due to the resistance to therapy, non-adherence or early discontinuation of their adjuvant therapy, such as tamoxifen and AIs.
This indicates the need for more adjuvant options to treat early breast cancer and prevent progression to advanced, incurable disease.
Under the terms of a pre-study agreement, Sanofi will provide funding, as well as the investigational drug for the AMEERA-6 trial, while BIG will perform the study within its network.
EORTC, an academic clinical research organisation, will be responsible for managing the study, data analysis, and medical management. AFT will handle the US portion of the study.
Sanofi will carry out the trial in some countries outside the academic networks’ geographical scope.
Last week, Sanofi stopped the clinical programme of venglustat in autosomal dominant polycystic kidney disease (ADPKD) after the Phase II/III STAGED-PKD trial failed to meet the futility criteria.