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Radiation + Pembrolizumab + Olaparib for Breast Cancer
Phase 2
Recruiting
Led By Atif Khan, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have adequate organ function as defined in the provided table
Ability to swallow (whole) and retain oral medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks from baseline
Awards & highlights
Study Summary
This trial is testing whether adding pembrolizumab and/or olaparib to standard radiation therapy can improve outcomes for patients with TNBC.
Who is the study for?
This trial is for women at least 18 years old with metastatic or recurrent triple-negative or hormone-receptor positive/Her2 negative breast cancer. Participants must not be pregnant, breastfeeding, and should follow contraceptive guidance. They need to have stable organ function and performance status (ECOG) of 0-1. Those with HIV, active TB or hepatitis, severe allergies to study drugs, certain previous treatments or conditions that could affect the study's outcome are excluded.Check my eligibility
What is being tested?
The trial tests if adding pembrolizumab (an immunotherapy drug), with or without olaparib (a targeted therapy drug), to standard radiation therapy is more effective for treating metastatic breast cancer than radiation alone. The safety and effectiveness of these combinations are being compared.See study design
What are the potential side effects?
Potential side effects include immune system reactions leading to inflammation in various organs, infusion-related reactions from pembrolizumab; nausea, vomiting, fatigue from olaparib; and skin irritation from radiation. Side effects can vary based on individual patient health.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My organs are functioning well according to the test results.
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I can swallow and keep down pills.
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My triple-negative breast cancer worsened after ICI treatment or is PDL1-negative.
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I am not pregnant, not breastfeeding, and follow birth control advice if it applies to me.
Select...
I am a woman over 18 with triple negative breast cancer or ER+/Her2.
Select...
I have been on a stable dose of corticosteroids for at least 4 weeks.
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I have given a sample of my tumor for testing.
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My breast cancer has spread or come back and is triple-negative or estrogen receptor-positive.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks from baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks from baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response Rate
Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
3Treatment groups
Experimental Treatment
Group I: Arm C (activate new arm)Experimental Treatment3 Interventions
Participants will have metastatic ER+ breast cancer (ER+ MBC) Treatment will be pembro/SBRT/Olaparib)
Group II: Arm B (the study is amended to pause Arm B)Experimental Treatment2 Interventions
Participants will have triple negative breast cancer diagnosis Treatment will be pembro + RT only
Group III: Arm AExperimental Treatment3 Interventions
Participants will have triple negative breast cancer diagnosis Treatment will be pembro + RT + olaparib
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Olaparib
FDA approved
Radiation
2003
Completed Phase 3
~1020
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,588 Total Patients Enrolled
202 Trials studying Breast Cancer
81,103 Patients Enrolled for Breast Cancer
Atif Khan, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
3 Previous Clinical Trials
117 Total Patients Enrolled
2 Trials studying Breast Cancer
91 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A
- Group 2: Arm B (the study is amended to pause Arm B)
- Group 3: Arm C (activate new arm)
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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