drugset / Trial / NCT05929768

Shorter Chemo-Immunotherapy Without Anthracycline Drugs for Early-Stage Triple Negative Breast Cancer

NCT05929768 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

This phase III trial compares the effects of shorter chemotherapy (chemo)-immunotherapy without anthracyclines to usual chemo-immunotherapy for the treatment of early-stage triple negative breast cancer. Paclitaxel is in a class of medications called anti-microtubule agents. It stops cancer cells from growing and dividing and may kill them. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It may also lower the body's immune response. Docetaxel is in a class of medications called taxanes. It stops cancer cells from growing and dividing and may kill them. Doxorubicin is an anthracycline chemotherapy drug that damages DNA and may kill cancer cells. Pembrolizumab may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Shorter treatment without anthracycline chemotherapy may work the same as the usual anthracycline chemotherapy treatment for early-stage triple negative breast cancer.

Timeline

Start
2023-09-15
Primary completion
2033-03-31
Completion
2033-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cyclophosphamide Other / unclassified — Intravenous
Subject Docetaxel Small molecule — Intravenous
Comparator Doxorubicin Other / unclassified — Intravenous
Comparator Paclitaxel Small molecule — Intravenous
Background Carboplatin Small molecule — Intravenous
Background Pembrolizumab Monoclonal antibody — Intravenous