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PD-1 Inhibitor
Cemiplimab + Chemotherapy for Breast Cancer
Phase 2
Recruiting
Led By Lubna Chaudhary, MD
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adequate organ function with baseline lab values: Absolute neutrophil count (ANC) ≥ 1500/µL, Hemoglobin (Hb) ≥ 8g/dL, Platelet count ≥ 100,000/µL, Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3x institutional upper limit of normal (ULN), Serum bilirubin within ≤ 1.5 x ULN except patients with Gilbert's syndrome for whom the direct bilirubin should be within normal range, Creatinine clearance of ≥ 30 mL/min, International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN. This applies to patients not receiving therapeutic anticoagulation. Patients on therapeutic anticoagulation should be on a stable dose, Thyroid-stimulating hormone (TSH) ≤ institutional ULN
Pathologically proven diagnosis of invasive breast cancer, cT1-T3, cN0-N3, cM0, HR+ (ER+ and/or PR+) HER2 negative or HR- (ER- and PR-) HER2 negative/triple negative breast cancer
Must not have
Treatment with any investigational drug within 30 days of registration. Prior treatment with any immunotherapy or chemotherapy for this breast cancer
Men with breast cancer. Male breast cancer is a rare event
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 27 weeks from start of treatment
Awards & highlights
No Placebo-Only Group
Summary
This trial is studying a targeted cancer therapy as a possible treatment for breast cancer.
Who is the study for?
This trial is for women with invasive breast cancer that's either hormone receptor positive and HER2 negative, or triple-negative. They should be candidates for neoadjuvant chemotherapy, have no prior treatments for this cancer or any other malignancy in the past two years (except certain non-melanoma skin cancers), and must not be pregnant or breastfeeding. Participants need to agree to use contraception if of childbearing potential.
What is being tested?
The study tests Cemiplimab alone or with a combination of Paclitaxel, optional Carboplatin, Doxorubicin, and Cyclophosphamide in patients with high-risk or locally advanced breast cancer. It's an open-label phase 2 trial where all participants receive the experimental treatment without a comparison group.
What are the potential side effects?
Potential side effects include immune-related reactions such as inflammation in different organs, infusion reactions similar to allergic responses during drug administration, fatigue, nausea from chemotherapy drugs like Doxorubicin and Cyclophosphamide, blood cell count changes due to bone marrow suppression by Paclitaxel and Carboplatin.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood and organ tests show I'm healthy enough for treatment.
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My breast cancer is invasive, not spread to distant organs, and is either hormone receptor positive or triple negative.
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My cancer is HER2 negative according to the latest tests.
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I am female.
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My heart's pumping ability is within the normal range.
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I can take care of myself and am up and about more than half of my waking hours.
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I am 18 years old or older.
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My tumor shows PD-L1 or PD-L2 protein expression in at least 1% of cells.
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My tumor is positive for estrogen or progesterone.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't taken any experimental drugs or had immunotherapy or chemotherapy for my breast cancer in the last 30 days.
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I am a man diagnosed with breast cancer.
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I haven't taken strong immune system medications in the last 2 weeks.
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My breast cancer is noninvasive, without any invasive type present.
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My cancer has spread to other parts of my body.
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My cancer is HER2 positive based on specific tests.
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I have moderate to severe numbness, tingling, or pain in my hands or feet.
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My heart or lung condition is not well-controlled despite medication.
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I have had serious heart failure symptoms.
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I have a history of autoimmune disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 27 weeks from start of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~27 weeks from start of treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of subjects with pathological complete response.
Side effects data
From 2023 Phase 3 trial • 608 Patients • NCT0325726725%
Pyrexia
13%
Infusion related reaction
13%
Vomiting
13%
Nausea
13%
Constipation
13%
Diarrhoea
13%
Subcutaneous abscess
13%
Hyperthyroidism
100%
80%
60%
40%
20%
0%
Study treatment Arm
Chemotherapy to Cemiplimab*
Cemiplimab
Chemotherapy*
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Drug TreatmentExperimental Treatment5 Interventions
Cemiplimab, Paclitaxel, Carboplatin (not mandatory), Doxorubicin, Cyclophosphamide
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cemiplimab
2015
Completed Phase 3
~1470
Paclitaxel
2011
Completed Phase 4
~5450
Doxorubicin
2012
Completed Phase 3
~8030
Cyclophosphamide
2010
Completed Phase 4
~2310
Find a Location
Who is running the clinical trial?
Medical College of WisconsinLead Sponsor
635 Previous Clinical Trials
1,181,666 Total Patients Enrolled
15 Trials studying Breast Cancer
409,473 Patients Enrolled for Breast Cancer
Lubna Chaudhary, MDPrincipal Investigator - Medical College of Wisconsin
Community Memorial Hospital, Froedtert & The Medical College of Wisconsin
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have cancer in both breasts, both are HER2 negative, and I am considered for chemotherapy before surgery.I am using two forms of birth control and will continue for 6 months after my last chemo dose.I haven't taken any experimental drugs or had immunotherapy or chemotherapy for my breast cancer in the last 30 days.I am a man diagnosed with breast cancer.I have had a CT, bone, PET scan, or MRI as my doctor thought was necessary.I haven't taken strong immune system medications in the last 2 weeks.My breast cancer is invasive, not spread to distant organs, and is either hormone receptor positive or triple negative.I haven't been treated for any cancer, except skin cancer or early-stage cervical or breast cancer, in the last 2 years.My cancer is HER2 negative according to the latest tests.I have cancer in more than one area and am eligible for chemotherapy before surgery.I've had a CT, PET, MRI, or bone scan as my doctor thought was needed.I do not have active Hepatitis B or C, or if previously infected, it is now resolved.I am female.My blood and organ tests show I'm healthy enough for treatment.My breast cancer is noninvasive, without any invasive type present.My heart's pumping ability is within the normal range.I have cancer in more than one spot and am eligible for chemotherapy before surgery.I am either postmenopausal, surgically sterile, or not pregnant.I have another cancer type, but it's not skin cancer or early-stage cervical cancer.I've had a breast imaging test within the last 30 days.My cancer has spread to other parts of my body.I can take care of myself and am up and about more than half of my waking hours.I am 18 years old or older.I have a skin condition like eczema or psoriasis, but it's mild and treated with low-strength creams.I have an autoimmune thyroid condition but am stable on my thyroid medication.My cancer is HER2 positive based on specific tests.My tumor shows PD-L1 or PD-L2 protein expression in at least 1% of cells.I have moderate to severe numbness, tingling, or pain in my hands or feet.My heart or lung condition is not well-controlled despite medication.My tumor is positive for estrogen or progesterone.My doctor recommends chemotherapy before surgery for my breast cancer.I have Type 1 diabetes managed with a stable insulin routine.You have tested positive for HIV.I have had serious heart failure symptoms.I had cancer in my other breast but finished all treatments over two years ago.I have a history of autoimmune disease.
Research Study Groups:
This trial has the following groups:- Group 1: Drug Treatment
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.