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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages Any age
• All sexes
• No healthy volunteers
• Child, Adult, Older adult

Trial locations and contacts

31 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

About this study

Official title: 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).

Conditions

Metastatic Breast Cancer, HER2-negative Breast Cancer, ER+ Breast Cancer, Advanced Breast Cancer, Metastatic Breast Cancer With Bone Involvement, Bone Metastases in Subjects With Advanced Breast Cancer

Being tested

RYZ101, Standard of Care Endocrine Therapy

Keywords

Actinium, Alpha-Emitter, SSTR+ MBC, ER+, HER2-, MBC, RYZ101, 225Ac, Targeted Radiotherapy, Radiopharmaceutical, SSTR+ ABC, ER+, HER2-, ABC

Medical subject headings

Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• RYZ101Drug

  Ac-225

• Standard of Care Endocrine TherapyDrug

  Investigator's choice of endocrine therapy, such as, anastrozole, elacestrant, exemestane, fulvestrant, imlunestrant, letrozole, tamoxifen, or vepdegestrant

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Dose Escalation

   Incidence rate of DLTs during the first 6 weeks of RYZ101 treatment

   Measured: 6 weeks of RYZ101 treatment

2. Endocrine Therapy Combination Dose Escalation

   Incidence rate of DLTs during the first 6 weeks of study treatment

   Measured: [Time Frame: 6 weeks of study treatment]

3. Endocrine Therapy Combination Dose Escalation

   Incidence and severity of treatment emergent AEs by NCI-CTCAE v5.0

   Measured: Up to approximately 5 years after the last subject has completed RYZ101 treatment

4. Endocrine Therapy Combination Dose Escalation and Expansion

   Progression Free Survival, defined as the time between first dose of study treatment and progression or death, as assessed by the investigator per RECIST v1.1 criteria

   Measured: Up to approximately 5 years after the last subject has completed RYZ101 treatment

5. Endocrine Therapy Combination Dose Escalation and Expansion

   Time from the first dose of study treatment to first occurrence of Skeletal Related Events

   Measured: Up to approximately 5 years after the last subject has completed RYZ101 treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted19 Sep 2024
2. Study start19 Jul 2024
3. Primary completionOct 2028 (estimated)
4. Study completionNov 2033 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.