Actively Recruiting
A Pilot Study to Explore the Efficacy and Safety of Dasatinib Combined With Quercetin to Reverse Chemotherapy Resistance in Triple Negative Breast Cancer
Led by Fudan University · Updated on 2024-07-08
10
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a Phase II, open-label, single-arm study to evaluate the safety and effectiveness of combining dasatinib and quercetin with chemotherapy in women with metastatic triple-negative breast cancer (mTNBC) who have shown progression during previous chemotherapy. This study addresses the urgent clinical problem of chemotherapy resistance in this aggressive breast cancer subtype by exploring new treatment strategies based on promising preclinical results. Participants receive combined treatment with dasatinib (50 mg on days 1 to 3 weekly), quercetin (1000 mg on days 1 to 3 weekly), and chemotherapy drugs such as taxane, anthracycline, eribulin mesylate, vinorelbine, capecitabine, carboplatin, or platinum agents. The treatment aims to reduce chemotherapy resistance by targeting senescent fibroblasts and tumor cell proliferation. This study does not include a control group and focuses on a single treatment arm. During the study, participants will be monitored for objective response rate up to 6 months, with additional assessments including disease control rate, progression-free survival, safety, and biomarker analysis. Safety and treatment-related adverse events will be followed for up to 12 months. Participants will have regular evaluations including laboratory tests and imaging to assess disease progression and treatment effects, with the total duration of follow-up extending up to a year.
CONDITIONS
Brief Title
Dasatinib Combined With Quercetin to Reverse Chemo Resistance in Triple Negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- ECOG Performance Status of 0 or 1
- Diagnosed with metastatic or locally advanced triple-negative breast cancer confirmed by tissue tests
- Evidence of cancer recurrence or progression after chemotherapy for metastatic breast cancer
- Adequate blood and organ function based on lab tests within 14 days before starting treatment
- Women of childbearing potential agree to abstain or use contraception as required
- Measurable cancer according to standardized criteria (RECIST v1.1)
- Ability to understand the study and willingness to participate and be followed up
You will not qualify if you...
- Symptomatic, untreated, or actively progressing brain metastases
- Active or past autoimmune disease or immune deficiency
- Significant heart disease
- Other cancers within the past 5 years except low-risk types
- Received chemotherapy, radiotherapy, immunotherapy, or surgery (except minor outpatient) within 3 weeks before study treatment
- Pregnant, breastfeeding, or planning pregnancy during the study
- Allergies to any study drug components
- Long-term use of oral steroid hormones unless stopped for 4 weeks if used occasionally
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months or until disease progression or loss of clinical benefit
Participants receive combined treatment with dasatinib, quercetin, and chemotherapy to reverse chemotherapy resistance in triple negative breast cancer.
Weekly visits for treatment and assessments
Duration - Up to 6 months after treatment or until death
Participants are monitored for safety and treatment-related adverse events after treatment ends.
Periodic visits for safety monitoring
Trial Site Locations
Total: 1 location
1
270 Dongan Road, Fudan University Shanghai Cancer Center
Shanghai, China, 200032
Actively Recruiting
Research Team
Z
Zhimin Shao, MD, PhD
Y
Yin Liu, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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