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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
No Placebo-Only Group
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months post-therapy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months post-therapy
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 moreOther study objectives
Percent difference in gene expression of SSTR2+ breast cancer cell populations
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
Glufosfamide: can we improve the process of anticancer agent development?Signal transduction pathways: the molecular basis for targeted therapies.
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Who is running the clinical trial?
OHSU Knight Cancer InstituteLead Sponsor
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2,088,570 Total Patients Enrolled
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NovartisIndustry Sponsor
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Oregon Health and Science UniversityOTHER
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7,412,320 Total Patients Enrolled
5 Trials studying Breast Cancer
396 Patients Enrolled for Breast Cancer
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had cancer, but it has been completely treated and there has been no sign of it for at least 5 years, except for non-melanoma skin cancer or early stage cervical cancer that has been treated.Your kidney function needs to be good, which means the level of creatinine in your blood or the amount of creatinine cleared by your kidneys needs to be within a certain range.You have received radiation treatment to a large portion of your bone marrow in the past.Your platelet count is 75,000 or higher per microliter of blood.You have brain metastases that have not been treated and stabilized.You have a certain type of marker in your body that can be detected in a special scan.You have cancer that has spread to distant parts of your body.You are allergic to somatostatin analogues or any ingredients in the 68Ga-DOTATATE or 177Lu-DOTATATE treatments.Your body has enough infection-fighting white blood cells.Your diabetes is not well controlled, as shown by very high fasting blood sugar levels.You have a serious heart condition that is not well managed.You have had surgery or certain types of treatments within the last 12 weeks before joining the study.You have urinary incontinence that makes it unsafe to receive the radioactive study agent.You have a mental illness that makes it difficult for you to understand and agree to participate in the study.You have been diagnosed with advanced breast cancer.Women who are not confirmed to be past menopause.You have tried at least two types of standard treatments, and your disease has gotten worse.Your total bilirubin level should be within a certain range, as measured within 28 days before starting the study treatment.You must have recovered from the side effects of previous treatments, except for mild hair loss and mild nerve problems.You should be able to carry out light physical activities without needing help from others most of the time.You must have a tumor that can be measured and biopsied according to specific guidelines.You are currently taking certain medications for a medical condition that cannot be stopped around the time of the study treatment.The doctor thinks you will live for more than 6 months.You have received peptide receptor radionuclide therapy before joining the study.Your hemoglobin level is at least 8.0 g/dL and you have not had a blood transfusion in the past 28 days, as measured within 28 days before starting the study treatment.Your liver enzymes levels should not be too high, unless you have liver metastases, in which case they can be a little higher.You are currently taking part in another treatment study or have recently taken part in one within the last 4 weeks.Your blood albumin level needs to be at least 3.0 g/L, unless your prothrombin time or INR is normal.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (177Lu-DOTATATE)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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