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Cemiplimab in High-risk or Locally Advanced Luminal and Triple Negative Breast Cancer

NCT04243616 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-09-05

No results posted yet for this study

Summary

This is a single-arm, open-label, phase 2 study that will enroll 36 subjects, who have pathologically proven diagnosis of invasive breast cancer, clinical stage tumor 1-3 (cT1-T3), node 0-3 (cN0-N3), metastasis 0 (cM0), hormone receptor positive (HR+) (estrogen-receptor-positive (ER+) and/or progesterone-receptor-positive (PR+) human epidermal growth factor receptor 2 (HER2) negative or hormone receptor-negative (HR-) (estrogen-receptor-negative (ER-) and progesterone-receptor-negative (PR-) human epidermal growth factor receptor 2 (HER2) negative/triple-negative breast cancer.

Conditions

Interventions

DRUG

Cemiplimab

350 mg, IV, Day 1 of Cycle 1-2 (3-week cycle)

DRUG

Paclitaxel

80 mg/m\^2, IV, Day 1,8 and 15 of Cycles 1-4 (3-week cycle)

DRUG

Carboplatin (not mandatory)

Area under curve (AUC)=6, IV, Day 1 of Cycles 1-4 of Paclitaxel cycles (3-week cycle)

DRUG

Doxorubicin

60 g/m\^2, IV, Day 1 of Cycles 1-4 of ddAC (2-week cycle)

DRUG

Cyclophosphamide

600 g/m\^2, IV, Day 1 of Cycles 1-4 of dose-dense Adriamycin (Doxorubicin) and Cyclophosphamide (ddAC) (2-week cycle)

Sponsors & Collaborators

  • Medical College of Wisconsin

    lead OTHER

Principal Investigators

  • Lubna Chaudhary, MD · Medical College of Wisconsin

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-05
Primary Completion
2025-08-11
Completion
2030-08-12
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04243616 on ClinicalTrials.gov