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Pembrolizumab for Triple Negative Breast Cancer (Pembro/IORT Trial)
Pembro/IORT Trial Summary
This trial is testing a new cancer drug, pembrolizumab, to see if it is effective against triple negative breast cancer. The trial will assess the response to the drug in the primary tumor, normal breast tissue, and in circulating lymphocytes and serum exosomes.
Pembro/IORT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPembro/IORT Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Pembro/IORT Trial Design
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Who is running the clinical trial?
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- I am willing to use birth control during and for 4 months after the study.My cancer has spread to other parts of my body.I have had a stem cell transplant from a donor.You currently have active Hepatitis B or C.My main cancer lesion is larger than 3 cm, and I don't have cancer in my lymph nodes.I have another cancer besides skin, breast DCIS, or in situ cervical cancer that's active or was treated in the last 5 years.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I have multiple cancer areas within the same breast.I cannot have breast cancer radiation due to a medical condition or previous radiation.I have been treated with drugs targeting immune checkpoints.I am 21 years old or older.My breast cancer is triple negative, with very low or no hormone receptor levels.My cancer has not spread to my lymph nodes or other parts of my body.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I haven't had any cancer treatment or surgery in the last 6 months.I am currently being treated for an infection.You have had an organ transplant.I am fully active or restricted in physically strenuous activity but can do light work.You have a severe allergic reaction (Grade 3 or higher) to pembrolizumab or any of its ingredients.I have a history of active tuberculosis.My cancer spot is smaller than 3 cm.My breast size is B cup or larger, suitable for IORT.I have had pneumonitis treated with steroids or have it now.I have not received a live vaccine in the last 30 days.My organs are functioning well.
- Group 1: Single Arm open label
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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 what clinical situations is Merck 3475 Pembrolizumab typically prescribed?
"Merck 3475 Pembrolizumab is a frequently used therapeutic intervention for malignant neoplasms. There are also multiple other applications of this medication such as to treat unresectable melanoma, microsatellite instability high, and disease progression following chemotherapy."
Has Pembrolizumab (Merck 3475) been subject to any previous research endeavors?
"Currently, there are 122 Phase 3 trials and 963 live studies actively investigating Merck 3475 Pembrolizumab. These medical experiments have a primary presence in Houston, Texas; however 35772 distinct sites worldwide offer this therapy for research purposes."
To what extent could Merck 3475 Pembrolizumab be detrimental to a person's health?
"With limited evidence of its effectiveness and safety, Merck 3475 Pembrolizumab is rated a 1 on the scale of safety."
Does this clinical trial accept participants of an advanced age?
"Patients aged 21 to 80 are allowed to participate in this trial, with 93 trials dedicated for minors and 3225 studies catering to the elderly."
For what types of individuals is enrollment in this trial appropriate?
"Aspiring participants in this clinical trial must be female, aged between 21 and 80 years old, with triple negative breast cancer. Additional requirements include a pregnancy test within 72 hours prior to receiving medication, written informed consent/assent for the trial, histologically proven invasive breast carcinoma with triple negative receptor status (as determined by various tests), ≤ 3 cm unifocal lesion by imaging or physical examination; clinically node-negative without any evidence of metastatic disease; no anti-cancer treatment including investigational agents 6 months prior to study entry; B cup size or larger for IORT procedure; performance score of 0 or 1 on EC"
How many participants are accepted into this investigation?
"Affirmative, the information on clinicaltrials.gov indicates that this trial is currently seeking volunteers and has been since October 25th 2017. Last updated on October 10th 2022, the study requires a total of 15 participants to be recruited from one site."
Are there still opportunities for volunteers to participate in this experiment?
"Affirmative. The information posted on clinicaltrials.gov demonstrates that this trial is currently recruiting participants, with the first posting date being October 25th 2017 and a recent edit occurring on October 10th 2022. Only 15 candidates are required across 1 site to complete the study."
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