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

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
Medical College of Wisconsin
Study ID
NCT04243616
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Invasive Breast Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cemiplimab — DRUG
    350 mg, IV, Day 1 of Cycle 1-2 (3-week cycle)
  • Paclitaxel — DRUG
    80 mg/m\^2, IV, Day 1,8 and 15 of Cycles 1-4 (3-week cycle)
  • Carboplatin (not mandatory) — DRUG
    Area under curve (AUC)=6, IV, Day 1 of Cycles 1-4 of Paclitaxel cycles (3-week cycle)
  • Doxorubicin — DRUG
    60 g/m\^2, IV, Day 1 of Cycles 1-4 of ddAC (2-week cycle)
  • Cyclophosphamide — DRUG
    600 g/m\^2, IV, Day 1 of Cycles 1-4 of dose-dense Adriamycin (Doxorubicin) and Cyclophosphamide (ddAC) (2-week cycle)

Study Details

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.

Key Dates

Start date
Mar 5, 2020
Status verified
Aug 2025
Primary completion
Aug 11, 2025
Completion
Aug 12, 2030

Study Design

Enrollment
36 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Drug Treatment
    Cemiplimab, Paclitaxel, Carboplatin (not mandatory), Doxorubicin, Cyclophosphamide

Primary Outcome Measure

Number of subjects with pathological complete response. [ Time Frame: 27 weeks from start of treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
Froedtert Hospital & Medical College of WisconsinMilwaukeeWisconsin53226-

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By research site
Froedtert Hospital & Medical College of Wisconsin· Milwaukee, WI

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