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Magrolimab Combo for Triple-Negative Breast Cancer (ELEVATE TNBC Trial)
ELEVATE TNBC Trial Summary
This trial is testing the safety and effectiveness of two different combinations of drugs for people with triple-negative breast cancer that has spread.
ELEVATE TNBC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowELEVATE TNBC Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 1 & 2 trial • 78 Patients • NCT02953782ELEVATE TNBC Trial Design
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Who is running the clinical trial?
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- I have been treated with drugs targeting CD47 or signal regulatory protein alpha.I have active inflammatory bowel disease or had a bowel obstruction or perforation in the last 6 months.My condition worsened within 6 months after initial cancer treatment.I have untreated advanced TNBC that is PD-L1 negative.I have fully recovered from any major surgery before starting treatment.I haven't had hemolytic anemia, autoimmune thrombocytopenia, or Evans syndrome in the last 3 months.I have TNBC, treated with a taxane and up to 2 therapies, including an immune checkpoint inhibitor if PD-L1 positive.If you have nerve pain or hair loss, you can still join the study.I have brain involvement but it's stable and I haven't needed steroids for 4 weeks.I haven't taken high doses of steroids in the last 2 weeks.I still have moderate to severe side effects from a previous treatment.My overall health is good, and my blood, kidney, and liver are functioning well.You have a disease that can be measured using a specific set of guidelines.I have a known bleeding disorder.I have been treated with topoisomerase I inhibitors or specific antibody-drug conjugates before.I needed more than 2 blood transfusions in the last month.
- Group 1: Safety Run-in Cohort 2: Magrolimab + Sacituzumab govitecan
- Group 2: Phase 2 Cohort 1 Arm A: Magrolimab + Nab-Paclitaxel or Paclitaxel
- Group 3: Phase 2 Cohort 2: Magrolimab + Sacituzumab govitecan
- Group 4: Safety Run-in Cohort 1: Magrolimab + Nab-Paclitaxel or Paclitaxel
- Group 5: Phase 2 Cohort 1 Arm B: Nab-Paclitaxel or Paclitaxel
- 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
In how many medical facilities is this clinical trial being conducted?
"Presently, there are 14 enrolment centres for this trial. They are situated in Salt Lake City, Atlanta and Fresno as well as 11 other places. If you are thinking about participating in this study, it would be most convenient for you to choose a location near to you to cut down on travel time."
What kind of side effects has Magrolimab been known to cause in patients?
"Magrolimab's safety was given a score of 2 by our team at Power. This is because, while there is data supporting its safety, there is none yet proving its efficacy in Phase 2 of the trial."
Is this the first time Magrolimab has been studied?
"There are 888 live studies currently underway for Magrolimab. 237 of those are in Phase 3, the final stage before seeking FDA approval. Most of these trials taking place in Woolloongabba, Queensland, but there are 46612 total locations running these sorts of tests."
How many participants are being enrolled in this trial?
"Yes, the trial is recruiting patients at 14 sites across the United States of America. According to the study's information page on clinicaltrials.gov, it was originally posted on December 14th, 2021 and updated November 8th, 2022. The goal is to have 144 total participants."
Are people currently being accepted into this clinical trial?
"Yes. The clinical trial is recruiting patients at 14 sites across the United States of America. The study was posted on December 14th, 2021 and updated November 8th, 2022. They are currently looking for 144 individuals to participate."
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