Impact of Desloratadine on Treatment Response and Inflammation During Neoadjuvant Chemotherapy in Stage II-III Breast...

Desloratadine, commonly used for allergy symptoms, has demonstrated its potential to increase survival rates in patients with breast cancer. This trial aimed to assess the efficacy of desloratadine in improving treatment response and inflammation markers during neoadjuvant chemotherapy.

In this single-blind, pilot phase II trial, 49 patients with newly diagnosed breast cancer were randomized into two groups: an intervention group (n = 23), and a control group (n = 26). The intervention group received desloratadine in addition to anthracycline-based chemotherapy, while the control group received standard anthracycline-based chemotherapy alone. The primary endpoint was the treatment response, which was evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST). Secondary endpoints included plasma histamine, IL-6, TNF-α levels, and PBMC biomarkers (H1R, NF-κB, TLR-4).

Data from 20 patients in the intervention group and 22 patients in the control group were analyzed (patients in stages II and III were enrolled; no stage I cases were observed, and two stage IV patients [one per group] were excluded due to insufficient subgroup size). The intervention group showed a higher overall response rate (65%) than the control group (45.5%), though the difference was not statistically significant (p = 0.232). Stage III patients in the intervention group had a significantly higher response rate (90.91% [intervention] vs. 11.11% [control], p = 0.001). No adverse effects were reported.

Desloratadine may improve treatment response in stage III breast cancer, supporting its potential role as a complementary agent in neoadjuvant chemotherapy.

This study was registered with the Iranian Registry of Clinical Trials (IRCT) under the registration number IRCT20230221057485N1.