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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
270 Dongan Road, Fudan University Shanghai Cancer Center
Shanghai, China
RECRUITINGObjective Response Rate (ORR)
Time frame: Baseline until disease progression or loss of clinical benefit, assessed up to 6 months
Disease Control Rate (DCR)
Time frame: Baseline through end of study, assessed up to 6 months
Progression Free Survival (PFS)
Time frame: Randomization to death from any cause, through the end of study,assessed up to 6 months
Safety and treatment-related AEs
Time frame: Randomization to death from any cause, through the end of study,assessed up to 12 months
Biomarker analysis1
the pre- and post-treatment levels of age-related secretory factors and neutrophil extracellular traps in serum and lung puncture samples.
Time frame: Baseline until disease progression or loss of clinical benefit, assessed up to 6 months
Biomarker analysis2
Immunohistochemical staining of tissue sections before and after treatment including number of senescent fibroblasts, number and area of neutrophil extracellular traps.
Time frame: Baseline until disease progression or loss of clinical benefit, assessed up to 6 months
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