RYZ101 ( 225 Ac-DOTATATE) in patients with estrogen receptor-positive, human epidermal growth factor receptor 2–negative, locally advanced and unresectable, or metastatic breast cancer progressing after prior therapy: The phase 1b/2 TRACY-1 study
Abstract
TPS3184
Background:
RYZ101 (actinium-225 [
225
Ac]-DOTATATE) is a radiolabeled somatostatin analog (SSA) for the treatment of patients with solid tumors expressing somatostatin receptor-type 2 (SSTR2). RYZ101 is composed of the alpha-emitting radioisotope
225
Ac, the chemical chelator DOTA (tetraxetan), and SSA octreotate (TATE). RYZ101 binds with high affinity to SSTR2 on the cell surface and is internalized, whereupon the alpha-particle emission of
225
Ac results in lethal double-strand DNA breaks. Although SSTR-directed therapy is widely used in patients with well-differentiated gastroenteropancreatic neuroendocrine tumors (GEP-NETs), its relevance in non-GEP-NET SSTR-expressing neoplasms is still emerging. Clinical positron emission tomography (PET) imaging studies have reported SSTR expression in estrogen receptor (ER)-positive breast cancer. Available data support investigating the efficacy of RYZ101 in patients with ER-positive, HER2-negative, locally advanced and unresectable or metastatic breast cancer.
Methods:
TRACY-1 (NCT06590857) is a global, multicenter, open-label, two-part (dose escalation and expansion) phase 1b/2 study. Key inclusion criteria are: age ≥18 years; histologically confirmed, ER-positive, HER2-negative locally advanced and unresectable or metastatic breast cancer not amenable to curative-intent treatment; endocrine-refractory disease; documented progression (per RECIST v1.1) after ≥2 and ≤4 prior lines of chemotherapy and/or ADC (≥1 must be ADC…
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