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：
1. No more than 3 lines of prior systemic therapy for advanced disease
2. No more than 1 line of chemotherapy or antibody-drug conjugate (ADC) administered in the advanced setting
3. No prior CDK4/6 inhibitor therapy for advanced disease, or only 1 line of CDK4/6 inhibitor therapy with treatment duration \> 6 months
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
You may not be if
Patients with leptomeningeal metastases, brainstem metastases or skull metastases
Prior receipt of anti-angiogenic agents or Culmerciclib
Unresolved Grade ≥2 toxicities (per CTCAE Version 6.0) attributable to any prior therapy, except alopecia
Patients with visceral crisis,defined as severe organ dysfunction assessed by symptoms, signs, laboratory examinations and rapid disease progression
Inability to swallow capsules or tablets
Any severe and/or uncontrolled medical disease
Other malignancies diagnosed within 5 years, excluding cured non-melanoma skin cancer, cervical carcinoma in situ and papillary thyroid carcinoma
Radiographic evidence of tumor invasion of major vessels, or high risk of tumor invasion into major vessels resulting in life-threatening hemorrhage as assessed by the investigator
Patients with arterial or venous thromboembolic events within 6 months, such as cerebrovascular accident, deep vein thrombosis and pulmonary embolism
Participation in other anti-tumor clinical trials within 4 weeks prior to enrollment
Any other condition that the investigator considers inappropriate to participate in this trial
Clareo Health | Culmerciclib Plus Anlotinib and Endocrine Therapy for HR-Positive/HER2-Negative Metastatic Breast Cancer With Brain Metastases
