OncoMatch/Clinical Trials/NCT05187832
A Study of AND019 in Women With ER Positive HER2 Negative Advanced or Metastatic Breast Cancer
Is NCT05187832 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies AND019 PO QD for advanced or metastatic breast cancer.
Treatment: AND019 PO QD — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) negative
Required: ESR1 positive
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: endocrine therapy — advanced or metastatic
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
Cannot have received: selective estrogen receptor degrader
Previous treatment with any SERDs
Lab requirements
Blood counts
Sufficient bone marrow reserve and organ function
Kidney function
Sufficient bone marrow reserve and organ function
Liver function
Sufficient bone marrow reserve and organ function
Sufficient bone marrow reserve and organ function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Sarah Cannon Research Institute · Nashville, Tennessee
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