This study aims to evaluate the efficacy and safety of adding the anti-angiogenic agent anlotinib to the combination of the CDK2/4/6 inhibitor Culmerciclib and endocrine therapy in patients with HR+/HER2- breast cancer and brain metastases. Eligible patients present with newly diagnosed brain metastases or brain metastases that progressed following prior local therapy. It is hoped that this therapeutic combination can achieve disease control in these patients.
Inclusion Criteria:
Women aged ≥ 18 years
ECOG PS of 0-1
Life expectancy of at least 12 weeks
histologically or cytologically documented HR+/HER2- breast cancer
radiologically confirmed brain parenchymal metastases without the need for immediate local therapy
measurable brain metastasis lesion according to RANO-BM criteria
Must have active brain metastases, defined as newly diagnosed brain metastases or progressive brain metastases following prior local therapy
Prior systemic therapy must meet all the following criteria:
Adequate hematological, hepatic and renal function
Women of child bearing potential must agree to use a contraceptive method during the treatment period and for at least 180 days after the last dose of experiment treatment
Patients must be able to participate and comply with treatment and follow-up
Exclusion Criteria:
wangshs@sysucc.org.cn
Patients receive culmerciclib plus anlotinib and endocrine therapy
Guangzhou, Guangdong 510060, China
wangshs@sysucc.org.cn+8613926168469
46300349@hebmu.edu.cn+8613503216325
fanyuguo201@163.com+8615037272967
zxs_8112@126.com+8615638167115
Sherry01130@163.com+8613605169652
chenwenyannc2013@163.com+8613970890626
1357396467@qq.com+8617709878607
luckyluojy@163.com+8618981838521
czred@sina.com+8613606505124
A Phase II Clinical Study of the Efficacy and Safety of Culmerciclib Rechallenge in HR-positive, HER2-negative Breast Cancer Patients With Resistance to First-line Endocrine Therapy.
Efficacy and Safety of Culmerciclib Plus Aromatase Inhibitors in a Response-Adapted Neoadjuvant Strategy for Highly Proliferative ER-Positive/HER2-Negative Breast Cancer
Study on the Treatment of HER2-negative Breast Cancer Brain Metastases With Radiotherapy Combined With Anlotinib
Phase Ib/II Trial of Abemaciclib and Elacestrant in Patients With Brain Metastasis Due to HR+/Her2- Breast Cancer
Brain Radiotherapy Combined With Dalpiciclib and Endocrine Therapy in HR-Positive/HER2-Negative Advanced Breast Cancer With Brain Metastases
Palbociclib, Trastuzumab,Pyrotinib and Fulvestrant Treatment in Patients With Brain Metastasis From ER/PR Positive, HER-2 Positive Breast Cancer: A Multi-center, Prospective Study in China