RightFit
RecruitingPhase 1 / Phase 2

Trial of 225Ac-DOTATATE (RYZ101) in Subjects With ER+, HER2-negative Unresectable or Metastatic Breast Cancer Expressing SSTRs.

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) (TRACY-1).

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
No age limits stated
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests 225Ac-DOTATATE (RYZ101) alone or with hormone therapy for breast cancer that cannot be removed by surgery or has spread. It is for people whose cancer uses estrogen to grow (ER-positive), is HER2-negative, and has markers called somatostatin receptors (SSTRs).

Phase 1b/2 open-label trial of 225Ac-DOTATATE (RYZ101) in subjects with ER+, HER2-negative unresectable or metastatic breast cancer expressing SSTRs.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • A tissue test must confirm ER-positive, HER2-negative breast cancer that is advanced or has spread and cannot be treated with the goal of a cure.
  • Your kidneys, liver, and blood cell levels must work well enough for the study.
  • RYZ101-only group: Cancer must be measurable, and at least 80% of cancer spots must show SSTRs on a special PET scan.
  • RYZ101-only group: You must be able to care for yourself and be out of bed or a chair for more than half of waking hours (ECOG score 0–2).
  • RYZ101-only group: Scans must show cancer growth after 2–4 prior chemotherapy or antibody-drug conjugate treatments for cancer that has spread. These conjugates carry cancer drugs to cancer cells.
  • Hormone therapy groups: You must have had a CDK4/6 inhibitor, a drug that slows cancer cell growth, with hormone therapy for advanced or spreading cancer. You must be fully active or limited only in hard physical activity (ECOG score 0–1).
  • Hormone therapy groups: Cancer must be only or mainly in the bones. At least one bone spot must test positive on both SSTR-PET and FDG-PET scans. If cancer is mainly in the bones, at least 50% of measurable soft-tissue spots must show SSTRs.
  • Hormone therapy groups: Cancer that has spread to the brain is allowed if it has been fully treated and follow-up scans show it is stable.

Who can't join

  • Past treatment with radioactive medicines, including radioactive particles placed in blood vessels to treat cancer.
  • Side effects from past treatments that are still more than mild, except hair loss.
  • Serious heart or blood vessel disease.
  • Active, uncontrolled, or symptom-causing cancer in the brain or spinal cord; cancer in their lining; or pressure on the spinal cord.
  • An allergy to 225Ac, 68Ga, 64Cu, octreotate, or any other ingredient in DOTATATE imaging agents.
  • Another past or current cancer that could affect study safety or how results are measured.
  • Pregnancy or breastfeeding.
  • Hormone therapy groups: Cancer in the liver or cancer causing symptoms in other internal organs; past treatment with PARP inhibitors, a type of cancer drug; or eligibility for these drugs under local guidelines.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria Subjects must meet all the following criteria for enrollment in the study: * Histologically confirmed, ER+, HER2-negative, locally advanced and unresectable or metastatic breast cancer not amenable to treatment with curative intent. * Adequate renal, hematologic, and hepatic function * Additional inclusion criteria for Monotherapy arm: * Measurable disease with at least 80% SSTR-positive lesions by SSTR-PET imaging * Eastern Cooperative Oncology Group (ECOG) performance status ≤2 * Documented radiologic progression after at least 2 and no more than 4 prior chemotherapy or ADC regimens in the metastatic setting * Additional inclusion criteria for ET Combination arms: * Prior treatment with CDK4/6 inhibitors in combination with endocrine therapy in the advanced or metastatic setting. * Eastern Cooperative Oncology Group (ECOG) performance status ≤1 * Bone only or bone dominant disease. At least 1 bone lesion must be SSTR-positive on SSTR-PET imaging. For bone dominant disease, at least 50% of soft tissue measurable lesions must be SSTR-positive on SSTR-PET imaging. At least one bone lesion must be positive on both SSTR-PET and on FDG-PET imaging * Brain metastases are allowed if definitively treated and clinically stable as confirmed by interval imaging Exclusion Criteria 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 breastfeeding * Additional exclusion criteria for ET Combination arms: * Presence of liver metastases or symptomatic metastatic visceral disease * Prior PARPi exposure or are candidates for PARPi per local guidelines

Study sites (25)

AZ

CA

CO

FL

GA

IN

MA

MI

MN

MO

NE

NM

NY

OH

PA

TX

UT

VA

WA