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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 below
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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:
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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 weeks
Treatment ~ Varies
Follow Up ~27 weeks from start of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 27 weeks from start of treatment for reporting.

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 • NCT03257267
25%
Pyrexia
13%
Subcutaneous abscess
13%
Diarrhoea
13%
Hyperthyroidism
13%
Nausea
13%
Constipation
13%
Infusion related reaction
13%
Vomiting
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
631 Previous Clinical Trials
1,181,922 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

Cemiplimab (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04243616 — Phase 2
Breast Cancer Research Study Groups: Drug Treatment
Breast Cancer Clinical Trial 2023: Cemiplimab Highlights & Side Effects. Trial Name: NCT04243616 — Phase 2
Cemiplimab (PD-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04243616 — Phase 2
~1 spots leftby Jan 2025
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