Randomized Short-term Pre-surgical Study to Assess the Effects of Abemaciclib (LY2835219) in Early Breast Cancer Patients
Status:
Completed
Trial end date:
2018-02-02
Target enrollment:
Participant gender:
Summary
Cyclins CDK4 / 6 are extensively involved in the proliferation and growth of numerous cancers
including breast cancer. The objective of this study is to identify if a new preoperative
oral treatment, abemaciclib directed against the CDK / 6 compared to no treatment, inhibits
tumor growth or induced senescence (aging) tumor.
This early study is offered to women who are going to be operated on for breast cancer with
expression of hormone receptor (ER and / or PR). These women will have 3 chances to receive
one for up to 14 days in the waiting period of their surgery abemaciclib as tablets. Other
patients do not receive treatment. The decision to receive or no treatment will be done by a
random computer draw.
The drug's effectiveness will be evaluated primarily on the biological parameters of the
tumor itself when comparing surgery to before treatment. These results biomarkers will allow
us to better know how this treatment and eventually will be used in future to identify
patients for whom treatment with abemaciclib more efficiency.
Patients treated in the protocol will then receive treatment entirely conventional in their
breast cancer within the parameters of their tumors: their participation is very limited in
time.