MedTrace Logo

Dendritic Cell-Based Treatment Plus Immunotherapy for the Treatment of Metastatic or Unresectable Triple Negative Breast Cancer

NCT05539365 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2025-01-29

No results posted yet for this study

Summary

This phase II trial tests the safety, side effects, and whether dendritic cell-based treatment and pembrolizumab work in treating patients with triple negative breast cancer that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). The term triple-negative breast cancer refers to the fact that the cancer cells don't have estrogen or progesterone receptors (ER or PR) and also don't make any or too much of the protein called HER2 (the cells test "negative" on all 3 tests). Dendritic cell-based treatment works by boosting the immune system (a system in our bodies that protects us against infection) to recognize and destroy the cancer cells. Pembrolizumab, is an immune checkpoint inhibitor drug, that works by targeting molecules that act as a check and balance system for immune responses. Immune checkpoint inhibitor drugs are designed to either "unleash" or "enhance" the cancer immune responses that already exist by either blocking inhibitory molecules or by activating stimulatory molecules. Giving dendritic cell-based therapy and pembrolizumab may decrease symptoms and improve quality of life in patients with triple negative breast cancer.

Conditions

  • Anatomic Stage III Breast Cancer AJCC v8
  • Anatomic Stage IV Breast Cancer AJCC v8
  • Metastatic Triple-Negative Breast Carcinoma
  • Unresectable Triple-Negative Breast Carcinoma

Interventions

BIOLOGICAL

Alpha-type-1 Polarized Dendritic Cells

Given IT

PROCEDURE

Biopsy

Undergo biopsy

PROCEDURE

Computed Tomography

Undergo CT scan

PROCEDURE

Leukapheresis

Undergo leukapheresis

BIOLOGICAL

Pembrolizumab

Given IV

OTHER

Quality-of-Life Assessment

Ancillary studies

Sponsors & Collaborators

  • Roswell Park Cancer Institute

    lead OTHER

Principal Investigators

  • Shipra Gandhi · Roswell Park Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-01
Primary Completion
2027-02-01
Completion
2027-02-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT05539365 on ClinicalTrials.gov