NCT06355024

Inosine Reverse Chemo Resistance in Triple Negative Breast Cancer

a Pilot Study to Explore the Efficacy of Inosine Reversing Chemo Resistance in Triple Negative Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Triple-negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Inosine	oral inosine 200mg tid
DRUG	Taxane/Anthracycline/Eribulin Mesylate/Vinorelbine/Capecitabine/Carboplatin/UTD1/platinum	Taxane/Anthracycline/Eribulin Mesylate/Vinorelbine/Capecitabine/Carboplatin/UTD1/platinum

Timeline

• Start date: 2024-05-11
• Primary completion: 2025-01-01
• Completion: 2025-01-01
• First posted: 2024-04-09
• Last updated: 2025-07-18

Locations

1 site across 1 country: China