NCT05749575

Chidamide Plus PD-1 Plus Paclitaxel of Neoadjuvant Treatment in Low HR Expression,HER2-negative Early Breast Cancer.

A Prospective, Open-label, Phase II Clinical Trial of Chidamide, PD-1 Monoclonal Antibody and Paclitaxel in Neoadjuvant Therapy for Low Hormone Receptor(HR) Expression,HER2-negative Early Breast Cancer.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Triple-negative breast cancer has always been a difficult problem in clinical practice because of its young onset age, high aggressiveness, no clear therapeutic target and poor clinical prognosis. The treatment of triple-negative breast cancer is mainly chemotherapy, and in order to break the current dilemma, new treatments must be introduced. Immunotherapy is one of the most high-profile treatments. The KEYNOTE-522 study and Impassion 031 Study have found that immunotherapy can significantly improve the pCR of patients with triple yin breast cancer, rate, independent of PD-L1 expression status, and good safety.Cedardenamine is a histone deacetylation (HDAC) inhibitor developed in China.Many studies suggest that the use of sidabamine will likely enhance the efficacy of PD-1 / PD-L1 mAb in breast cancer and expand the use of PD-1 / PD-L1 mAb in the beneficiary population of breast cancer

Detailed description

Cedaramine can effectively inhibit subtypes 1,2,3 of HDAC class I and type 10 of class IIb. Sidabamide can directly induce cycle arrest and apoptosis in tumors and has demonstrated its clinical role in lymphoma and breast cancer.besides, In recent years, many studies have found that HDAC inhibitors also have their functions in regulating immunity, Such as: 1) upregulated tumor antigen / co-stimulatory molecule / receptor levels of tumor cells (such as MHC I / II, PRAME, MIC A/B, PDL-1, etc.), Make it easier to be recognized by the immune system; 2) Initialize the natural immune system, Activating NK cell activity; 3) Initialize the acquired immune system, Activating initial T cells (Naive T cells) to target tumor antigen; 4) Increase the CD8 + effector cells that kill tumor cells, Downregulation of the immunosuppressive cells, Such as the Treg 6 7 and MDSC, Promote the formation and maintenance of acquired immune memory T cells. Preclinical studies suggested that HDAC was synergistic with PD-1 / PD-L1 antibodies and could serve as a sensitizer for PD-1 / PD-L1 antibodies. A phase I study in solid tumors found that sitabenamine combined with natureumab had an objective response rate (ORR) of 48% and a disease control rate (DCR) of 87%.Therefore, we conduct this study to observe the efficacy and safety of neoadjuvant therapy in early HR low-expression ,HER2-negative breast cancer patients treated with PD-1 mAb and paclitaxel.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Chidamide Plus Toripalimab Plus Paclitaxel	Each participant receives chidamide plus toripalimab plus paclitaxel

Timeline

• Start date: 2023-02-01
• Primary completion: 2023-08-01
• Completion: 2024-08-01
• First posted: 2023-03-01
• Last updated: 2023-03-01

Locations

1 site across 1 country: China