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.
Women aged ≥ 18 years
ECOG PS of 0-1
Life expectancy of at least 12 weeks
histologically or cytologically documented HR+/HER2- breast cancer
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