NCT06355037

Dasatinib Combined With Quercetin to Reverse Chemo Resistance in Triple Negative Breast Cancer

a Pilot Study to Explore the Efficacy and Safety of Dasatinib Combined With Quercetin to Reverse Chemotherapy Resistance in Triple Negative Breast Cancer.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• 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 dasatinib, quercetin 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 dasatinib, quercetin with chemotherapy in mTNBC (triple negative breast cancer) patients who progressed during 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. Our preclinical studies have demonstrated that the combination of dasatinib and quercetin with chemotherapy can effectively eliminate chemotherapy-induced senescent fibroblasts, decrease the proliferation rate of disseminated tumor cells, and ultimately lead to a significant reduction in metastasis and recurrence, thereby enhancing the efficacy of chemotherapy. 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 treatment of dasatinib, quercetin 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	Quercetin	quercetin 1000mg d1-d3, qw
DRUG	Dasatinib	Dasatinib 50mg d1-d3, qw
DRUG	Taxane/Anthracycline/Eribulin Mesylate/Vinorelbine/Capecitabine/Carboplatin/UTD1/platinum	Taxane/Anthracycline/Eribulin Mesylate/Vinorelbine/Capecitabine/Carboplatin/UTD1/platinum

Timeline

• Start date: 2024-05-20
• Primary completion: 2024-12-31
• Completion: 2025-01-31
• First posted: 2024-04-09
• Last updated: 2024-07-08

Locations

1 site across 1 country: China