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Lenvatinib + Pembrolizumab for Breast Cancer
Study Summary
This trial is testing a new cancer treatment that could be curative for people with triple negative breast cancer.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT03004183Trial Design
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Who is running the clinical trial?
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- I am HIV positive, on effective treatment, with undetectable virus levels and a high CD4 count.I am eligible for surgery aimed at curing my condition.My breast cancer was confirmed by a biopsy and is at a certain stage according to specific criteria.I am mentally and physically capable of participating in a clinical trial.My cancer has not spread to distant parts of my body.I can understand and follow the study's procedures for its duration.I haven't taken lenvatinib or immune checkpoint inhibitors in the last 2 years.I can care for myself and am up and about more than 50% of my waking hours.I have not had a stroke or mini-stroke in the last 6 months.I am planning to have surgery to remove my breast tumor and check the nearby lymph nodes after chemotherapy.My breast cancer is triple-negative.I have severe heart failure or my heart's pumping ability is below 50%.I have a biopsy sample available for analysis.My recent tests show my organs are functioning well.I am using two effective birth control methods or practicing total abstinence as a woman able to have children.You have had or currently have another type of cancer that could affect the safety or effectiveness of the new treatment you will receive.I have had treatments like chemotherapy or radiation for my current breast cancer.I am currently on medication for an infection.I haven't had major surgery or am recovered from its major side effects in the last 14 days.I have not had any major abdominal issues like a fistula, perforation, or abscess in the last 28 days.I have had a heart attack or other serious heart issues in the last 6 months.I do not have serious heart rhythm problems, or if I do, I have a pacemaker.I am 18 years old or older.
- Group 1: Open Label
- 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 upper threshold of participants for this research endeavor?
"Affirmative, the information on clinicaltrials.gov reveals that this medical trial is still recruiting subjects. It was first published on July 9th 2020 and last modified on June 22nd 2022. The study needs to enrol 12 people between a single research site."
What medical maladies has Pembrolizumab been effective in addressing?
"Pembrolizumab is an immunotherapy agent primarily employed to battle malignant neoplasms. It can also be utilized in the treatment of obscure melanoma, microsatellite instability high disorders, and post-chemotherapy disease progression."
What other research has been undertaken in relation to the efficacy of Pembrolizumab?
"Currently, 1034 studies are researching the effects of Pembrolizumab with 134 of them being in phase 3. Sacramento, California is home to a number clinical trials on this topic; however there exist 37106 other locations conducting research related to it as well."
Are there current vacancies for participants in this clinical experiment?
"Affirmative. According to information hosted on clinicaltrials.gov, the trial that was initially advertised on July 9th 2020 is presently recruiting participants with 12 patients needed across 1 centre."
To what extent does Pembrolizumab pose a risk to individuals?
"Our risk assessment at Power gave Pembrolizumab a score of 1 due to limited clinical evidence on both its safety and effectiveness, as this is only the first stage in drug trials."
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