Cancer Clinical Trials
Trial of 225Ac-DOTATATE (RYZ101) in Subjects With ER+, HER2-negative Unresectable or Metastatic Breast Cancer Expressing SSTRs. (TRACY-1)
Learn moreWhat is the purpose of this study?
Phase 1b/2 open-label trial of 225Ac-DOTATATE (RYZ101) in subjects with ER+, HER2-negative unresectable or metastatic breast cancer expressing SSTRs.
Eligibility
Subjects must meet all the following criteria for enrollment in the study:
- Eastern Cooperative Oncology Group performance status ≤2.
- Histologically confirmed, ER+, HER2-negative, locally advanced and unresectable or metastatic breast cancer not amenable to treatment with curative intent.
- At least one RECIST v1.1-measurable tumor lesion that is SSTR-PET positive (defined as maximum standard uptake value (SUVmax) higher than liver mean standard uptake value (SUVmean) on SSTR-PET imaging) and at least 80% of RECIST v1.1measurable tumor lesions are SSTR-PET positive
- Sufficient renal function, as evidenced by eGFR ≥60 mL/min/1.73m2 calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
- Adequate hematologic and hepatic function
Subjects who meet any of the following criteria will be excluded from the study:
- Prior radiopharmaceutical therapy, including radioembolization.
- Any toxicities from prior treatments that have not recovered to CTCAE Grade ≤1, except for alopecia.
- Significant cardiovascular disease
- Known active uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, spinal cord compression, or leptomeningeal disease.
- History of hypersensitivity or allergy to 225Ac, 68Ga, 64Cu, octreotate, or any of the excipients of DOTATATE imaging agents.
- Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the study safety or efficacy assessments.
- Pregnancy or lactation.
Where can I participate?
More about this Clinical TrialWhat is the full name of this Clinical Trial?
Phase 1b/2 Open-label Trial of 225Ac-DOTATATE (RYZ101) in Subjects With Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor Receptor 2 (HER2)-Negative, Locally Advanced and Unresectable or Metastatic Breast Cancer Expressing Somatostatin Receptors (SSTRs) and Progressed After Antibody-drug Conjugates and/or Chemotherapy (TRACY-1).
- Disease Type/ConditionBreast Cancer Metastatic, HER2-negative Breast Cancer, ER+ Breast Cancer, Advanced Breast Cancer
- Principal InvestigatorGary Ulaner, MD
- Co-InvestigatorsRyan P. Reddy, MD, Alain Mita, MD, Monica M. Mita, MD, Chaitali S. Nangia, MD, Tara E. Seery, MD, Esther Lamb, PA, Laura Beals, NP
- Age GroupAdult, Older Adult
- PhaseII
- ClinicalTrials.gov IDNCT06590857
- Key Eligibilityclinicaltrials.gov
- How do I learn more about this study?Lauren Wagner
lauren.wagner@hoag.org
Hoag Family Cancer Institute
Hoag Family Cancer Institute delivers advanced, compassionate cancer care across Orange County, with multidisciplinary specialists, precision therapies, support services, and access to 125+ cancer clinical trials. Patients benefit from research-driven care across a wide range of cancers, including breast, lung, gynecologic, prostate, gastrointestinal, and blood cancers.
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