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Clinical Trial Summary

This is a Phase II, open-label, single-arm study evaluating the efficacy and safety of combined treatment of Inosine with chemotherapy in mTNBC (triple negative breast cancer) patients who progressed during previous chemotherapy.


Clinical Trial Description

This is a Phase II, open-label, single-arm study evaluating the efficacy and safety of combined treatment of Inosine with chemotherapy in metastatic TNBC (triple negative breast cancer) patients who progressed during or following previous chemotherapy. Chemotherapy is the backbone drug for TNBC. How to reverse chemotherapy resistance or how to increase the sensitivity of chemotherapy efficacy, has become an urgent clinical problem to be solved. The preclinical results show that Inosine play a potentially important role in regulating the tumor microenvironment. The investigators found that inosine from intestinal probiotics was negatively correlated with breast cancer recurrence and metastasis after chemotherapy, and further functional experiments showed that inosine-producing flora or dietary supplementation with inosine could significantly inhibit the survival of tumor cells after chemotherapy and inhibit the recurrence and metastasis of breast cancer. Furthermore, it is considered to have a high level of safety. Based on preclinical studies, the investigators designed this study to enroll mTNBC patients who have progressed during or following chemotherapy, and to explore the efficacy of combined inosine with chemotherapy at a clinical level, providing new strategies of combined treatment for TNBC patients. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06355024
Study type Interventional
Source Fudan University
Contact Zhimin Shao, MD, PhD
Phone 08664175590
Email zhimingshao@yahoo.com
Status Not yet recruiting
Phase Phase 2
Start date April 10, 2024
Completion date January 31, 2025

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