NCT05645380

Neoadjuvant TIL- and Response-Adapted Chemoimmunotherapy for TNBC

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 139 (estimated)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

This study will assess if the presence of immune system cells in and around the tumor impacts tumor shrinkage in patients receiving neoadjuvant chemoimmunotherapy for triple-negative breast cancer.

Detailed description

Triple negative breast cancers (TNBC) with enrichment of immune system cells in and around the tumor are more sensitive to chemoimmunotherapy and have better prognosis. Imaging is often used during the course of neoadjuvant chemoimmunotherapy to monitor how the disease is responding to treatment, and disappearance of a patient's tumor on imaging after chemoimmunotherapy usually means that the tumor will have completely disappeared when the patient goes for surgery. This study will test whether the presence of immune system cells in and around the tumor and the response of the tumor on MRI can be used to personalize the type and amount of neoadjuvant chemoimmunotherapy for patients with TNBC.

Conditions

• Triple Negative Breast Cancer
• Breast Cancer

Interventions

Type	Name	Description
DRUG	Carboplatin	AUC=6, IV
DRUG	Docetaxel	75 mg/m2, IV
DRUG	Doxorubicin	60 mg/m2, IV
DRUG	Cyclophosphamide	600 mg/m2, IV
DRUG	Pembrolizumab	200 mg, IV

Timeline

• Start date: 2022-12-05
• Primary completion: 2026-03-01
• Completion: 2026-12-01
• First posted: 2022-12-09
• Last updated: 2025-10-07

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study