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PD-1 Inhibitor
PD-1 Inhibition +/- IL-4 Inhibition for Breast Cancer
Phase 2
Waitlist Available
Research Sponsored by Ottawa Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Invasive ductal or lobular carcinoma, invasive carcinoma Not Otherwise Specified (NOS)
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights
Study Summary
This trial looks at using two approved drugs to treat early stage ER+ breast cancer before it spreads.
Who is the study for?
This trial is for women with newly diagnosed ER+ breast cancer, who haven't started treatment and are awaiting surgery. They must be able to consent, have a specific type of tumor (ER+ defined as ≥1% positive cells), not have metastasized cancer or certain lung diseases, no recent chemo or endocrine therapy, no serious infections or immune conditions requiring high-dose steroids.Check my eligibility
What is being tested?
The study tests Cemiplimab alone (Arm A) versus Cemiplimab combined with Dupilumab (Arm B) in patients with early-stage ER+ breast cancer. These drugs are approved but used off-label here to see if they can benefit patients before surgery during the 'Window of Opportunity' period.See study design
What are the potential side effects?
Potential side effects include allergic reactions to either drug, possible inflammation in organs like lungs (pneumonitis), fatigue, skin reactions at injection sites, and increased risk of infection due to immune system suppression.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is of a specific type (ductal, lobular, or NOS).
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I am able to care for myself and perform daily activities.
Select...
My cancer is HER2 negative according to specific tests.
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I am 18 years old or older.
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My breast cancer is ER+ with 1-10% positive cells.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Immune Cell Population Analysis
Secondary outcome measures
Study Participant Assessment of Adverse Effects
Other outcome measures
PD-1 Gene Expression
Side effects data
From 2023 Phase 3 trial • 608 Patients • NCT0325726725%
Anaemia
20%
Nausea
17%
Fatigue
16%
Vomiting
15%
Decreased appetite
15%
Constipation
11%
Asthenia
11%
Back pain
11%
Pyrexia
11%
Diarrhoea
10%
Arthralgia
9%
Urinary tract infection
9%
Dyspnoea
9%
Abdominal pain
7%
Cough
7%
Oedema peripheral
7%
Hypoalbuminaemia
7%
Headache
6%
Pain in extremity
6%
Rash
6%
Blood creatinine increased
6%
Insomnia
6%
Hypokalaemia
6%
Hypothyroidism
5%
Pruritus
5%
Vaginal haemorrhage
4%
Alanine aminotransferase increased
4%
Aspartate aminotransferase increased
4%
Pelvic pain
4%
Stomatitis
3%
Neutropenia
2%
Acute kidney injury
1%
Immune-mediated hepatitis
1%
Autoimmune hepatitis
1%
Febrile neutropenia
1%
Pneumonia
1%
Pyelonephritis
1%
Thrombocytopenia
1%
Neutrophil count decreased
1%
Pyelonephritis acute
1%
White blood cell count decreased
1%
Sepsis
1%
Duodenal ulcer
1%
Haematuria
1%
Hydronephrosis
1%
Hyperpyrexia
1%
Kidney infection
1%
Pneumonitis
1%
Hyperglycaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cemiplimab
Investigator Choice (IC) Chemotherapy
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm B: Cemiplimab + DupilumabExperimental Treatment1 Intervention
Arm B: Cemiplimab + Dupilumab (n=10), Cemiplimab 350mg IV x 1 dose + Dupilumab 600 mg SC x 1 dose administered prior to surgery.
Group II: Arm A: CemiplimabActive Control1 Intervention
Arm A: Cemiplimab (n=10), 350mg IV x 1 dose administered prior to surgery.
Find a Location
Who is running the clinical trial?
Ottawa Hospital Research InstituteLead Sponsor
561 Previous Clinical Trials
2,785,671 Total Patients Enrolled
34 Trials studying Breast Cancer
5,241 Patients Enrolled for Breast Cancer
Ontario Institute for Cancer ResearchOTHER
23 Previous Clinical Trials
9,165 Total Patients Enrolled
5 Trials studying Breast Cancer
712 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have significant difficulty with self-care and spend more than half of my waking hours in bed or a chair.I haven't had chemotherapy or hormone therapy for any cancer in the last 3 months.I am not on high-dose steroids or strong immune system medications.I haven't used any restricted medications, like chemotherapy or immunotherapy, in the last 4 weeks.I am scheduled for surgery within the next 4-6 weeks.I am a woman with a new diagnosis of invasive breast cancer and have not started treatment.You have had a serious allergic reaction to dupilumab or cemiplimab in the past.My breast cancer is of a specific type (ductal, lobular, or NOS).I am able to care for myself and perform daily activities.My breast cancer has spread to another organ.My cancer is HER2 negative according to specific tests.I am 18 years old or older.I have symptoms of COVID-19 and tested positive.My breast cancer is ER+ with 1-10% positive cells.I have or had lung inflammation or pneumonia in the last month.I can give my written consent to participate.My breast cancer is not the common types like ductal or lobular.I do not have an active infection and my white blood cell count is healthy.I don't have any health issues that would make the study drug dangerous for me.My kidney function is reduced, with a creatinine clearance below 50 mL/min.I have HIV or active Hepatitis B or C.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B: Cemiplimab + Dupilumab
- Group 2: Arm A: Cemiplimab
Awards:
This trial has 1 awards, including:- 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Am I qualified to register for this medical research?
"Individuals with breast cancer and aged between 18-90 can be eligible to take part in this study. Currently, there is a need for about 20 participants."
Answered by AI
Does the protocol for this experiment permit applicants over 25 years of age?
"To join this clinical trial, individuals must be within the age bracket of 18-90. There are 67 studies for minors and 2562 specifically designed to accommodate those above 65 years old."
Answered by AI
Is there still enrollment for the trial participants?
"This clinical experiment is no longer recruiting, according to the information posted on clinicaltrials.gov on 8/4/2023 and updated on 7/22/2023. Nevertheless, there are still 2657 other medical trials looking for participants at this moment in time."
Answered by AI
Has the combination of Cemiplimab and Dupilumab been granted authorization by the FDA?
"We rate the safety of Arm B: Cemiplimab + Dupilumab as a 2 due to limited evidence; while there is data demonstrating its safety, it has not been tested for efficacy."
Answered by AI
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