J Clin Oncol: Abemaciclib combined endocrine therapy to treat HR-HER2-lymph node-positive high-risk breast cancer.

With the standard therapy currently available, many patients with HER2-Early Breast Cancer (EBC) do not relapse or relapse in the distance.
but up to 30% of patients have high-risk clinical/pathological characteristics and may experience distant recurrences, mostly in previous years.
for this type of patient, better treatment options are needed to prevent early recurrence and metastasis.
Abemaciclib is an oral, continuous dose cdK4/6 inhibitor that has been approved for use in HR-HER2-Advanced Breast Cancer (ABC).
this study is an open-label Phase III trial that recruits patients with high-risk advanced breast cancer (who have underwent surgery as well as radiotherapy and/or complementary/new complementary chemotherapy) to evaluate the efficacy and safety of Abemaciclib in ABC.
patients were required to have 4 positive lymph nodes or 1-3 positive lymph nodes plus tumors of 5 cm, histology level 3, or Ki-67 plus 20%.
(study process) subjects were randomly assigned to the Standard Assisted Endocrine Therapy (ET) group in or out of the Amaciclib (150 mg, 2/day, for 2 years).
end point is invasion-free survival (IDFS), and secondary endpoints include distant recurrence-free survival, overall survival, and safety.
(IDFS in both groups and non-recurrence survival in the distance) was analyzed in the medium term of expected efficacy, 323 IDFS were observed in 5,637 patients who intended to be treated.
IDFS for Abemaciclib combined ET therapy is better than single-use ET therapy (risk ratio 0.75, 95% CI 0.60-0.93), and the two-year IDFS rate is 92.2% vs 88.7%, respectively.
security is consistent with the data already available at Abemaciclib.
when used in co-use with ET, Abemaciclib was the first CDK4/6 inhibitor to be shown to significantly improve IDFS in patients with a high risk of early recurrence of HR-HER2-lymph nodes.
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