A Study of AND019 in Women With ER Positive HER2 Negative Advanced or Metastatic Breast Cancer
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Key Inclusion Criteria: 1. Postmenopausal women defined as NCCN guideline at the time of informed consent. 2. Histological or cytological confirmation of advanced or metastatic ER+/HER2- breast cancer women who failed standard therapy or for which no standard therapy exists. 3. Prior therapy: 1. No more than 1 line of chemotherapy for advanced breast cancer 2. 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 4. ECOG score 0-1. 5. Minimum life expectancy of a least 3 months as determined by the Investigator. 6. Evaluable disease per RECIST 1.1; for patients consent to tissue biopsy, disease suitable for tumor biopsy. 7. Sufficient bone marrow reserve and or