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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
Ability to swallow (whole) and retain oral medications
Prior receipt of ICI with progression and/or PDL1-negative for mTNBC patients
Must not have
Concomitant use of known strong CYP3A inhibitors or moderate CYP3A inhibitors
Known history of active TB
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks from baseline
Awards & highlights
Approved for 10 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group
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.
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.
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...
I can swallow and keep down pills.
Select...
My triple-negative breast cancer worsened after ICI treatment or is PDL1-negative.
Select...
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 given a sample of my tumor for testing.
Select...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not taking strong or moderate CYP3A inhibitors.
Select...
I have an active tuberculosis infection.
Select...
I have not had major surgery in the last 2 weeks.
Select...
I have had a bone marrow or double cord blood transplant.
Select...
I had severe side effects from previous immunotherapy.
Select...
I cannot take pills by mouth or have stomach issues that affect medication absorption.
Select...
I am not taking any strong or moderate drugs that affect liver enzymes.
Select...
I have been diagnosed with HIV.
Select...
I haven't taken steroids or immunosuppressants in the last 7 days.
Select...
I have a history of Hepatitis B or an active Hepatitis C infection.
Select...
I have received an organ or tissue transplant from another person.
Select...
I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.
Select...
I have had more than 3 treatments for triple-negative breast cancer.
Select...
I have had pneumonitis treated with steroids or have it now.
Select...
I have lasting side effects from cancer treatment, but not hair loss.
Select...
I have brain metastases that are causing symptoms and are not under control.
Select...
I am currently on medication for an infection.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall Response Rate
Side effects data
From 2024 Phase 3 trial • 804 Patients • NCT0304099964%
Radiation skin injury
63%
Stomatitis
58%
Anaemia
56%
Nausea
48%
Dry mouth
45%
Constipation
45%
Weight decreased
44%
Dysphagia
42%
Neutrophil count decreased
33%
Dysgeusia
33%
Vomiting
32%
Fatigue
31%
White blood cell count decreased
28%
Hypomagnesaemia
26%
Decreased appetite
25%
Hypothyroidism
25%
Hypokalaemia
24%
Lymphocyte count decreased
24%
Platelet count decreased
23%
Oropharyngeal pain
23%
Blood creatinine increased
22%
Diarrhoea
22%
Odynophagia
20%
Hypoacusis
20%
Alanine aminotransferase increased
20%
Hyponatraemia
19%
Tinnitus
19%
Oral candidiasis
19%
Asthenia
16%
Pyrexia
16%
Cough
15%
Aspartate aminotransferase increased
15%
Rash
14%
Insomnia
13%
Acute kidney injury
13%
Pharyngeal inflammation
13%
Pruritus
12%
Dysphonia
12%
Gamma-glutamyltransferase increased
11%
Pneumonia
11%
Dehydration
10%
Hyperthyroidism
10%
Hypoalbuminaemia
10%
Hypocalcaemia
10%
Headache
10%
Productive cough
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Sepsis
3%
Pneumonia aspiration
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Systemic infection
1%
Clostridium difficile colitis
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab + CRT Followed by Pembrolizumab
Placebo + CRT Followed by Placebo
Awards & Highlights
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.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Olaparib
FDA approved
Pembrolizumab
FDA approved
Radiation
2003
Completed Phase 2
~780
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,979 Previous Clinical Trials
599,804 Total Patients Enrolled
207 Trials studying Breast Cancer
82,929 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:- 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.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.