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Pembrolizumab + Radiation for Breast Cancer
Study Summary
This trial is testing if pembrolizumab can be safely given with a tumor boost and if it helps the standard treatment work better.
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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- My cancer has been tested for ER, PR, and HER2.My cancer may or may not have spread to the lymph nodes.I am fully active or can carry out light work.Your lab test results must meet certain requirements.My breast cancer is HER2-positive based on specific test results.I have an immune system disorder or am on long-term steroids.I have another cancer that is getting worse or was treated in the last 3 years.I am planning to have surgery that will not remove my entire breast.I have cancer in both breasts at the same time.I am currently on medication for an infection.I cannot have breast-conserving therapy due to specific health reasons.I have been treated for an autoimmune disease in the last 2 years.I do not have any serious health issues that could make this study unsafe for me.I have breast implants that were in place before my cancer diagnosis.I have a history of HIV, Hepatitis B, or Hepatitis C.My largest cancer area is at least 2 cm big.I am using approved birth control methods and have had a negative pregnancy test.I am willing to have a biopsy for research in 4 weeks.I have been diagnosed with invasive breast cancer.My cancer has not spread to distant parts of my body.I am not currently on any treatments that are not allowed in this study.I have been diagnosed with inflammatory breast cancer.My tumor can be treated with an extra dose of radiation before surgery, as advised by my radiation oncologist.I cannot undergo radiation therapy or am not planning to have partial breast irradiation.My tumor is at least 2 cm big and can be operated on.My cancer has spread to other parts of my body.I have triple-negative breast cancer.My breast cancer is high-risk, ER-positive, and HER2-negative.I have had pneumonitis treated with steroids or currently have it.
- Group 1: Pembrolizumab with RT Boost
- 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 maladies has Pembrolizumab been prescribed to alleviate?
"Pembrolizumab has a wide range of clinical applications, especially in the oncology field. Patients with unresectable melanomas, high microsatellite instability and disease progression after chemotherapy can benefit from its use."
What additional research has been conducted related to Pembrolizumab?
"Presently, there are 961 ongoing trials researching pembrolizumab's efficacy, with 122 of these studies currently in Phase 3. With 35731 locations conducting clinical research for this drug, Houston stands out as the primary centre for Pembrolizumab testing."
What is the number of enrollees in this medical experiment?
"This research study is no longer recruiting patients. Initially published on December 22nd, 2017 and last amended on April 15th 2022, this trial has concluded its search for participants. However, if you are seeking alternative studies to join there are currently 2,600 clinical trials admitting those affected by breast cancer and 961 medical investigations taking part in pembrolizumab treatment actively looking for volunteers."
What are the objectives of this medical experiment?
"The primary aim of this study, monitored over an 8 week period post initiation, is to establish the number of patients who do not require a delay in their standard care treatment after receiving preoperative Pembrolizumab and radiation therapy. Secondary objectives include evaluating invasive disease-free survival following preoperative radiotherapy and pembrolimzumab; noting any treatment-related adverse events; as well as determining the pathological complete response rate - i.e., absence of invasive cancer cells within breast tissue or lymph nodes prior to surgical intervention."
Are individuals currently being accepted to take part in this research?
"Based on the information posted to clinicaltrials.gov, this research trial is not currently open for new volunteers. The study was initially published in December 2017 and edited most recently in April 2022; however, with 3561 other trials actively recruiting right now there are plenty of opportunities to get involved with medical research."
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