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Targeted Therapy

177Lu-DOTATATE for Advanced Breast Cancer

Phase 2
Waitlist Available
Led By SuEllen Pommier
Research Sponsored by OHSU Knight Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months post-therapy
Awards & highlights

Summary

This trial is testing a treatment called 177Lu-DOTATATE for patients with advanced or recurrent breast cancer that has a specific marker (SSTR2). The treatment works by using a molecule to find cancer cells and then delivering radiation to kill them. The goal is to see if this treatment can reduce the size and number of tumors and cancer stem cells in these patients. Lutetium Lu-177 dotatate (177Lu-DOTATATE) has shown significant benefits in treating somatostatin-receptor-positive neuroendocrine tumors.

Who is the study for?
This trial is for adults with stage IV or recurrent breast cancer that has progressed after at least two standard treatments. Participants must have tumors positive for SSTR2, adequate organ function, and agree to use effective contraception. Exclusions include other cancers within 5 years (except certain skin/cervical cancers), brain metastases, uncontrolled conditions like diabetes or heart failure, recent surgeries or therapies, and pregnancy.
What is being tested?
The trial tests the effectiveness of a targeted therapy called 177Lu-DOTATATE in patients with advanced breast cancer. This drug attaches to tumor cells expressing SSTR2 and delivers radiation directly to destroy them. The goal is to reduce tumor size and circulating cancer stem cells.
What are the potential side effects?
Potential side effects of 177Lu-DOTATATE may include nausea, fatigue, kidney damage due to radiation exposure, blood cell count changes leading to increased infection risk or bleeding problems, liver toxicity affecting its function, and allergic reactions related to the drug's components.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months post-therapy
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months post-therapy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Objective response rate (ORR)
Secondary study objectives
Disease control rate (DCR)
Duration of response (DOR)
Incidence of adverse events (AEs)
+1 more
Other study objectives
Percent difference in gene expression of SSTR2+ breast cancer cell populations

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (177Lu-DOTATATE)Experimental Treatment1 Intervention
Patients receive 177Lu-DOTATATE IV over 30-40 minutes during weeks 1, 8, 16, and 24 in the absence of disease progression or unacceptable toxicity.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
177Lu-DOTATATE is a targeted therapy that delivers radiation directly to SSTR2-positive tumor cells, potentially shrinking or destroying them. This approach is significant for breast cancer patients as it offers a more precise treatment option, minimizing damage to surrounding healthy tissues. Other common treatments for breast cancer include hormone therapy, which blocks hormones that fuel cancer growth; chemotherapy, which uses drugs to kill rapidly dividing cells; and HER2-targeted therapies, which inhibit the HER2 protein that promotes cancer cell growth. Targeted therapies like 177Lu-DOTATATE are particularly important as they can provide more effective and less toxic treatment options for patients with specific tumor characteristics.
Glufosfamide: can we improve the process of anticancer agent development?Signal transduction pathways: the molecular basis for targeted therapies.

Find a Location

Who is running the clinical trial?

OHSU Knight Cancer InstituteLead Sponsor
234 Previous Clinical Trials
2,088,618 Total Patients Enrolled
14 Trials studying Breast Cancer
2,317 Patients Enrolled for Breast Cancer
NovartisIndustry Sponsor
1,629 Previous Clinical Trials
2,726,621 Total Patients Enrolled
57 Trials studying Breast Cancer
21,145 Patients Enrolled for Breast Cancer
Oregon Health and Science UniversityOTHER
996 Previous Clinical Trials
7,387,670 Total Patients Enrolled
5 Trials studying Breast Cancer
396 Patients Enrolled for Breast Cancer

Media Library

Lutetium Lu 177 Dotatate (Targeted Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04529044 — Phase 2
Breast Cancer Research Study Groups: Treatment (177Lu-DOTATATE)
Breast Cancer Clinical Trial 2023: Lutetium Lu 177 Dotatate Highlights & Side Effects. Trial Name: NCT04529044 — Phase 2
Lutetium Lu 177 Dotatate (Targeted Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04529044 — Phase 2
~3 spots leftby Oct 2025