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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.

Phase 1RecruitingKind Pharmaceuticals LLCNCT05187832Data as of May 2026

Treatment: AND019 PO QDThis 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.

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Extracted 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

Max 1 prior line
Min 1 prior line

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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