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177Lu-DOTATATE for Advanced Breast Cancer
Study Summary
This trial is investigating whether 177Lu-DOTATATE can effectively treat breast cancer that has either spread to other parts of the body (stage IV) or come back after initial treatment (recurrent). 177Lu-DOTATATE works by targeting and destroying tumor cells that express the SSTR2 protein. This treatment is delivered through DOTATATE, which is linked to a radioactive agent called 177Lu. When DOTATATE comes in contact with tumor cells that express SSTR2, it delivers 177Lu to kill them. Researchers hope that giving 177Lu-DOTATATE to patients with SSTR2-positive breast cancer will shrink
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- 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.
- Group 1: Treatment (177Lu-DOTATATE)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
What is the overall participant count of this trial?
"Unfortunately, this experiment is not currently accepting any more volunteers. Initially posted on September 1st 2022 and last revised on July 7th 2022, it does not appear to be actively recruiting at the time of writing. However, there are 4558 breast cancer experiments that need participants as well as 23 studies involving Lutetium Lu 177 Dotatate seeking new enrollees."
What are the criteria for enrollment in this research project?
"This medical trial is accepting a total of 10 individuals aged between 18 and 100 who are diagnosed with breast cancer. Applicants must possess an estimated life expectancy above 6 months, be capable of understanding the study's scope, and consent to partake in it by signing the appropriate paperwork. Furthermore, they should have experienced disease progression after having undergone at least two lines of standard treatments or one prior line of chemotherapy (not just hormone therapy). Participants will also need to demonstrate tangible signs of somatostatin receptor-positive sites through DOTATATE imaging equivalent to that observed in healthy livers; as well as no more than grade 2 neuropathy aside from"
Has the Food and Drug Administration given its stamp of approval to Lutetium Lu 177 Dotatate?
"Our experts at Power rated the safety of Lutetium Lu 177 Dotatate a 2 due to Phase 2 trial data which suggests it is safe but has yet to prove efficacy."
Are there still enrollments available for this experiment?
"According to clinicaltrials.gov, this research is no longer seeking new recruits as of July 7th 2022; however, an abundance of clinical trials are still actively recruiting patients at the current time with a total of 4581 active studies listed."
Can you provide a summary of past experiments using Lutetium Lu 177 Dotatate?
"Presently, 23 medical trials are in progress for Lutetium Lu 177 Dotatate with 1 of them already at the third stage. While Iowa City is a primary research hub for this medication, there are 162 separate locations where studies concerning it take place."
Are adult participants able to join this particular clinical experiment?
"This medical investigation is recruiting individuals aged 18 and above, but no more than one hundred years old."
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