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Trial Title:
Dasatinib Combined With Quercetin to Reverse Chemo Resistance in Triple Negative Breast Cancer
NCT ID:
NCT06355037
Condition:
Triple-negative Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Carboplatin
Capecitabine
Vinorelbine
Dasatinib
Taxane
Quercetin
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Quercetin
Description:
quercetin 1000mg d1-d3, qw
Arm group label:
quercetin and dasatinib
Intervention type:
Drug
Intervention name:
Dasatinib
Description:
Dasatinib 50mg d1-d3, qw
Arm group label:
quercetin and dasatinib
Intervention type:
Drug
Intervention name:
Taxane/Anthracycline/Eribulin Mesylate/Vinorelbine/Capecitabine/Carboplatin/UTD1/platinum
Description:
Taxane/Anthracycline/Eribulin Mesylate/Vinorelbine/Capecitabine/Carboplatin/UTD1/platinum
Arm group label:
quercetin and dasatinib
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.
Criteria for eligibility:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
270 Dongan Road, Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhimin Shao, MD, PhD
Phone:
+8664175590
Contact backup:
Last name:
Yin Liu, MD
Phone:
+8664175590
Email:
liuyinfudan@163.com
Start date:
May 20, 2024
Completion date:
January 31, 2025
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06355037
