Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New radiation drug shows promise for Tough-to-Treat breast cancer

NCT ID NCT06590857

Disease control Sponsor: RayzeBio, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 25, 2026 · Updated 2 times

Summary

This early-phase trial tests a drug called RYZ101 in people with a specific type of advanced breast cancer (ER+, HER2-) that has not responded to standard treatments. The drug delivers radiation directly to cancer cells that have a certain marker (SSTR). The goal is to see if it is safe and can shrink tumors. About 16 participants will take part.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

16 people

The number who actually took part.

Started

Jul 2024

Expected to finish

Nov 2033

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Advanced breast cancer are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm estrogen-receptor positive breast cancer Her2-receptor negative breast cancer hormone receptor-positive breast cancer metastatic carcinoma in the bone

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced breast cancer Bone metastases in subjects with advanced breast cancer ER+ breast cancer ER-positive HER2-negative breast cancer Estrogen-receptor-positive breast cancer HER2-negative breast cancer Hormone-sensitive breast cancer Hormone-sensitive metastatic breast cancer Metastatic breast cancer Metastatic breast cancer with bone involvement

Contacts and locations

Locations

  • Research Facility

    Phoenix, Arizona, 85054, United States

  • Research Facility

    Irvine, California, 92618, United States

  • Research Facility

    San Diego, California, 92093, United States

  • Research Facility

    Santa Monica, California, 90404, United States

  • Research Facility

    Longmont, Colorado, 80504, United States

  • Research Facility

    Jacksonville, Florida, 32224, United States

  • Research Facility

    Atlanta, Georgia, 30322, United States

  • Research Facility

    Indianapolis, Indiana, 46202, United States

  • Research Facility

    Boston, Massachusetts, 02215, United States

  • Research Facility

    Detroit, Michigan, 48202, United States

  • Research Facility

    Rochester, Minnesota, 55905, United States

  • Research Facility

    St Louis, Missouri, 63130, United States

  • Research Facility

    Omaha, Nebraska, 68124, United States

  • Research Facility

    Albuquerque, New Mexico, 87109, United States

  • Research Facility

    Buffalo, New York, 14203, United States

  • Research Facility

    New York, New York, 10016, United States

  • Research Facility

    New York, New York, 10021, United States

  • Research Facility

    Cleveland, Ohio, 44195, United States

  • Research Facility

    Philadelphia, Pennsylvania, 19104, United States

  • Research Facility

    Pittsburgh, Pennsylvania, 15213, United States

  • Research Facility

    Dallas, Texas, 75246, United States

  • Research Facility

    Houston, Texas, 77024, United States

  • Research Facility

    Salt Lake City, Utah, 84132, United States

  • Research Facility

    Norfolk, Virginia, 23502, United States

  • Research Facility

    Seattle, Washington, 98109, United States

  • Research Facility

    Victoria, British Columbia, V8R 6V5, Canada

  • Research Facility

    Toronto, Ontario, M4N 3M5, Canada

  • Research Facility

    Toronto, Ontario, M5G 2M9, Canada

  • Research Facility

    Québec, Quebec, G1S 4L8, Canada

  • Research Facility

    Seoul, Seoul, 03080, South Korea

  • Research Facility

    Seoul, Seoul, 05505, South Korea

More trials for these conditions

Other studies related to the condition(s) this trial covers.