This is a first in human dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) activity, and preliminary anti-tumor activity of AND019 in postmenopausal women with advanced or metastatic estrogen receptor (ER)-positive (human epidermal growth factor receptor 2 \[HER2\]-negative) breast cancer.
Postmenopausal women defined as NCCN guideline at the time of informed consent.
Histological or cytological confirmation of advanced or metastatic ER+/HER2- breast cancer women who failed standard therapy or for which no standard therapy exists.
No more than 1 line of chemotherapy for advanced breast cancer
Recurrence or progression on at least one line of endocrine therapy in the advanced or metastatic disease setting and derived a clinical benefit from the endocrine therapy: Recurred or progressed while being treated with adjuvant endocrine therapy for a duration of at least 24 months, or progressed under endocrine therapy for more than 6 months in the advanced or metastatic setting
Previous treatment with any SERDs.
Patient any central nervous system metastasis.
Received chemotherapies within 3 weeks before the first dose.
Received systemic radiotherapy within 3 weeks before the first dose, or local radiotherapy within 7 days before the first dose