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Radiation + Pembrolizumab + Olaparib for Breast Cancer
Study Summary
This trial is testing whether adding pembrolizumab and/or olaparib to standard radiation therapy can improve outcomes for patients with TNBC.
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?
Media Library
- I am not taking strong or moderate CYP3A inhibitors.I have an active tuberculosis infection.My organs are functioning well according to the test results.I can swallow and keep down pills.My triple-negative breast cancer worsened after ICI treatment or is PDL1-negative.I am not pregnant, not breastfeeding, and follow birth control advice if it applies to me.I have had cancer treatment, including trial drugs, recently.I have not had major surgery in the last 2 weeks.I am a woman over 18 with triple negative breast cancer or ER+/Her2.You are pregnant, based on a recent test.I have had a bone marrow or double cord blood transplant.I have been on a stable dose of corticosteroids for at least 4 weeks.I had severe side effects from previous immunotherapy.I have had radiotherapy within the required time frame.I have not received a live vaccine in the last 30 days.I cannot take pills by mouth or have stomach issues that affect medication absorption.I am not taking any strong or moderate drugs that affect liver enzymes.I have been diagnosed with HIV.I haven't taken steroids or immunosuppressants in the last 7 days.I have a history of Hepatitis B or an active Hepatitis C infection.I have received an organ or tissue transplant from another person.I have given a sample of my tumor for testing.I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.I have had more than 3 treatments for triple-negative breast cancer.I have another cancer that hasn't needed treatment in the last 2 years.I have had pneumonitis treated with steroids or have it now.I have lasting side effects from cancer treatment, but not hair loss.I have brain metastases that are causing symptoms and are not under control.You have an ongoing autoimmune disease that needed strong medication in the last 2 years.I am currently on medication for an infection.You have a strong allergic reaction to certain medications or their ingredients.Your resting ECG shows uncontrolled heart problems that can possibly be fixed.My breast cancer has spread or come back and is triple-negative or estrogen receptor-positive.I do not have any serious, uncontrolled health issues or infections.I am fully active or restricted in physically strenuous activity but can do light work.
- Group 1: Arm A
- Group 2: Arm B (the study is amended to pause Arm B)
- Group 3: Arm C (activate new arm)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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 are the approved indications for Pembrolizumab?
"Pembrolizumab is frequently used to treat patients with melanoma that cannot be surgically removed. It can also help those at high risk for recurrence or microsatellite instability disease."
How many people are taking part in this experiment at most?
"That is correct. The clinical trial, which has been recruiting since April 21st 2021, is looking for 34 patients to enroll at 7 different sites."
How many different research facilities are overseeing this experiment?
"There are 7 primary centres for this study, with Memorial Sloan Kettering Bergen (Limited Protocol Activities) in Montvale, Memorial Sloan Kettering Commack (Limited Protocol Activities) in Commack, and Memorial Sloan Kettering Cancer Center (All Protocol Activities) in New york being a few of them."
Are patients currently being recruited for this trial?
"Yes, the information available on clinicaltrials.gov indicates that this trial is still actively recruiting patients. The study was first posted on 4/21/2021 and has since been updated on 10/19/2022. Currently, the research team is looking for 34 individuals from 7 different centres."
Has this clinical trial been done before?
"Pembrolizumab has been the subject of 1162 studies since 2005, with the first being a Phase 1 drug approval stage study sponsored by AstraZeneca. This original trial had 98 participants and was conducted across 66 countries in 3072 cities. 377 follow-up studies have been completed."
When did the FDA last greenlight pembrolizumab?
"Pembrolizumab falls into the Phase 2 category, meaning that while there is some evidence pointing to its safety, there is none yet suggesting that it is an effective treatment. Our team at Power gave it a score of 2."
Are there Pembrolizumab studies that have been completed in the past?
"1162 clinical trials involving Pembrolizumab are ongoing. Of these, 143 have reached Phase 3 status. The majority of these studies are based out of Houston, Texas; however, there are 43122 different locations running Pembrolizumab trials."
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