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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 27 weeks from start of treatment
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of subjects with pathological complete response.
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
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
~1340
Paclitaxel
2011
Completed Phase 4
~5380
Doxorubicin
2012
Completed Phase 3
~7940
Cyclophosphamide
1995
Completed Phase 3
~3770
Find a Location
Who is running the clinical trial?
Medical College of WisconsinLead Sponsor
609 Previous Clinical Trials
1,162,547 Total Patients Enrolled
14 Trials studying Breast Cancer
409,343 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it feasible to submit an application for this medical experiment currently?
"According to the records published on clinicaltrials.gov, this research project is currently recruiting volunteers. It was initially uploaded on March 5th 2020 and has been revised as recently as April 1st 2022."
Answered by AI
Has Cemiplimab been sanctioned by the Food and Drug Administration?
"Given that Cemiplimab is in Phase 2 of its clinical trials, there has been some data collected surrounding safety but none regarding efficacy; therefore it received a score of 2."
Answered by AI
Are there any additional investigations revolving around Cemiplimab?
"As of now, 2024 studies exploring Cemiplimab's efficacy are in progress with 469 trials currently in Phase 3. Philadelphia, Pennsylvania is the epicentre for many of these experiments though there are 88001 other research centres conducting their own investigations into this drug."
Answered by AI
Is this experiment the inaugural trial of its kind?
"Since it's debut in 1997, sponsored by Alfacell and involving 300 participants, cemiplimab has been a popular topic of study. Subsequent research allowed the drug to receive Phase 3 approval before 2024 further active studies were conducted around the world - spanning 3863 cities across 85 countries."
Answered by AI
What is the aggregate amount of participants taking part in this investigation?
"Affirmative. According to the records on clinicaltrials.gov, this research project is currently enrolling patients, with an initial post date of March 5th 2020 and a recent amendment made on April 1st 2022. The study aims to recruit 36 participants from one site."
Answered by AI
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