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Immunotherapy for Triple-Negative Breast Cancer
Study Summary
This trial will assess a new immunotherapy for Stage IV triple-negative breast cancer, to see if it is safe and effective.
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.Trial Design
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Who is running the clinical trial?
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- I don't have any health issues that would make it unsafe for me to take a new drug.You have tested negative for hepatitis B surface antigen (HBsAg) at the screening.I have not received a live vaccine in the last 28 days.I haven't taken any immune-boosting drugs in the last 4 weeks or longer.I have active tuberculosis.I am allergic to certain medication ingredients, including those from Chinese hamster ovary cells.I haven't had any cancer except for the one being studied or low-risk cancers in the last 5 years.I have previously been treated with specific immune therapy drugs.I have had cancer spread to the lining of my brain and spinal cord.I have high calcium levels in my blood.My breast cancer is advanced, cannot be surgically removed, and lacks HER2, ER, and PgR.I have had a previous transplant of stem cells or an organ.I have a history or risk of irregular heartbeats due to heart conditions or electrolyte issues.I have not taken any antibiotics or antiviral drugs in the last week.You have a history of a heart test (ECG) showing a significant abnormality.I have not had major surgery in the last 4 weeks.My tumor has been tested and shows PD-L1 expression.I haven't received any systemic therapy for my advanced TNBC.I am fully active or can carry out light work.My blood and organs are functioning well.My cancer is classified as HER2-low.I have or had an autoimmune disease or immune deficiency.I haven't taken any steroids or immune-suppressing drugs in the last 2 weeks.I have not had a heart or stroke issue in the last 3 months.I am allergic to ingredients in nab-paclitaxel.I have brain metastases that are untreated or getting worse.You have difficulty getting medicine through your veins.I have had lung conditions like pulmonary fibrosis but not due to radiation.My heart is healthy and functions well.You don't have hepatitis C virus, or if you tested positive for it before, you don't have it anymore.I need frequent procedures to remove fluid from my chest, heart area, or abdomen.You have a measurable tumor according to specific medical guidelines.I have been screened for hepatitis B with specific test results.You have had serious allergic reactions to certain types of medications made from human or animal proteins.I do not have HIV, or if I do, it is under control with treatment.My cancer has spread and can be measured outside of the bone.
- Group 1: Arm A
- Group 2: Arm B
- 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
Has Arm A been granted authorization by the Food and Drug Administration?
"With only limited clinical data supporting the safety of Arm A, our team has assigned it a score of 2. This is due to its Phase 2 status which implies that efficacy testing has yet to be conducted."
How many people can take part in this medical research?
"Yes, the information on clinicaltrials.gov confirms that this medical study is actively searching for participants. This trial was first advertised on June 29th 2023 and has recently been updated to reflect changes made by researchers. The total number of patients sought out is 160 from 1 location."
Are participants currently being enrolled in this clinical experiment?
"Affirmative, according to the information on clinicaltrials.gov this trial is currently enrolling patients. It was initially posted June 29th 2023 and most recently updated on June 1st 2023, with a goal of recruiting 160 individuals from one medical center."
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