Combining dasatinib and quercetin with chemotherapy for 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.
This study is testing if combining dasatinib and quercetin with chemotherapy can help people with metastatic triple-negative breast cancer who haven't responded to previous treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, dasatinib |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06355037 on ClinicalTrials.gov |
What this trial studies
This Phase II, open-label, single-arm study evaluates the safety and efficacy of dasatinib and quercetin combined with chemotherapy in patients with metastatic triple-negative breast cancer (mTNBC) who have experienced progression during previous chemotherapy. The study aims to address the urgent clinical challenge of chemotherapy resistance by exploring how this combination can enhance chemotherapy effectiveness. Preclinical studies suggest that this approach may reduce metastasis and recurrence by eliminating chemotherapy-induced senescent fibroblasts and decreasing tumor cell proliferation. The trial will enroll patients with measurable disease to assess the clinical benefits of this combined treatment strategy.
Who should consider this trial
Good fit: Ideal candidates are women with metastatic or locally advanced triple-negative breast cancer who have shown disease progression after prior chemotherapy.
Not a fit: Patients with untreated or actively progressing central nervous system metastases or significant cardiovascular disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for patients with chemotherapy-resistant triple-negative breast cancer.
How similar studies have performed: While this approach is based on promising preclinical findings, it represents a novel clinical strategy that has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ECOG Performance Status of 0, 1 * Metastatic or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression) * Radiologic/objective evidence of recurrence or disease progression after chemotherapy for metastatic breast cancer (MBC) * Adequate hematologic and end-organ function, laboratory test results, obtained within 14 days prior to initiation of study treatment. * For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures as outlined for each specific treatment arm * Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) * have the cognitive ability to understand the protocol and be willing to participate and to be followed up Exclusion Criteria: * Symptomatic, untreated, or actively progressing CNS metastases * Active or history of autoimmune disease or immune deficiency * Significant cardiovascular disease * History of malignancy other than breast cancer within 5 years prior to screening, with the exception of those with a negligible risk of metastasis or death * Treatment with chemotherapy, radiotherapy,immunotherapy or surgery (outpatient clinic surgery excluded) within 3 weeks prior to initiation of study treatment. * Pregnancy or breastfeeding, or intention of becoming pregnant during the study * History of allergies to the drug components of this trial * Patients who have been using oral steroid hormones for a long time will need to stop for 4 weeks if they have used them occasionally in the past
Where this trial is running
Shanghai
- 270 Dongan Road, Fudan University Shanghai Cancer Center — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Zhimin Shao, MD, PhD
- Email: zhimingshao@yahoo.com
- Phone: +8664175590
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.