NCT04243616

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Hypothesis: The addition of cemiplimab (PD-1 inhibitor) to standard neoadjuvant chemotherapy in patients with locally advanced HR+ HER2 negative or triple-negative (TN) breast cancer having positive PD-L1 and/or PD-L2 tumor expression will be associated with an increase in pathologic complete response of at least 20%. Primary Objectives: Assess pathologic responses in patients treated with neoadjuvant chemotherapy and cemiplimab.

Conditions

• Invasive Breast Cancer

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2020-03-05
• Primary completion: 2025-08-11
• Completion: 2030-08-12
• First posted: 2020-01-28
• Last updated: 2025-09-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study