Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06355037
Other study ID # B2024.1.30
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date April 10, 2024
Est. completion date January 31, 2025

Study information

Verified date April 2024
Source Fudan University
Contact Zhimin Shao, MD, PhD
Phone +8664175590
Email zhimingshao@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 10
Est. completion date January 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 70 Years
Eligibility 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

Study Design


Intervention

Drug:
Quercetin
quercetin 1000mg d1-d3, qw
Dasatinib
Dasatinib 100mg d1-d3, qw
Taxane/Anthracycline/Eribulin Mesylate/Vinorelbine/Capecitabine/Carboplatin/UTD1/platinum
Taxane/Anthracycline/Eribulin Mesylate/Vinorelbine/Capecitabine/Carboplatin/UTD1/platinum

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Fudan University

Outcome

Type Measure Description Time frame Safety issue
Primary Objective Response Rate (ORR) Baseline until disease progression or loss of clinical benefit, assessed up to 6 months
Secondary Disease Control Rate (DCR) Baseline through end of study, assessed up to 6 months
Secondary Progression Free Survival (PFS) Randomization to death from any cause, through the end of study,assessed up to 6 months
Secondary Safety and treatment-related AEs Randomization to death from any cause, through the end of study,assessed up to 12 months
Secondary Biomarker analysis1 the pre- and post-treatment levels of age-related secretory factors and neutrophil extracellular traps in serum and lung puncture samples. Baseline until disease progression or loss of clinical benefit, assessed up to 6 months
Secondary Biomarker analysis2 Immunohistochemical staining of tissue sections before and after treatment including number of senescent fibroblasts, number and area of neutrophil extracellular traps. Baseline until disease progression or loss of clinical benefit, assessed up to 6 months
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03639948 - Neoadjuvant Phase II Study of Pembrolizumab And Carboplatin Plus Docetaxel in Triple Negative Breast Cancer Phase 2
Withdrawn NCT02427581 - Safety and Immunogenicity of a Personalized Synthetic Long Peptide Breast Cancer Vaccine Strategy in Patients With Persistent Triple-Negative Breast Cancer Following Neoadjuvant Chemotherapy Phase 1
Completed NCT04584112 - A Study of the Safety, Efficacy, and Pharmacokinetics of Tiragolumab in Combination With Atezolizumab and Chemotherapy in Participants With Triple-Negative Breast Cancer Phase 1
Completed NCT01881230 - Evaluate Risk/Benefit of Nab Paclitaxel in Combination With Gemcitabine and Carboplatin Compared to Gemcitabine and Carboplatin in Triple Negative Metastatic Breast Cancer (or Metastatic Triple Negative Breast Cancer) Phase 2/Phase 3
Completed NCT03652077 - A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies Phase 1
Terminated NCT01918306 - GDC-0941 and Cisplatin in Treating Patients With Androgen Receptor-Negative Triple Negative Metastatic Breast Cancer Phase 1/Phase 2
Recruiting NCT04914390 - A Phase Ⅱ Study of Anlotinib Combined With Tislelizumab and AT in the Neoadjuvant Treatment of Triple-negative Breast Cancer Phase 2
Completed NCT03154749 - DCb (Docetaxel/Carboplatin) Versus EC-D (Epirubicin/Cyclophosphamide Followed by Docetaxe) as Neoadjuvant Chemotherapy for Triple-Negative Breast Cancer Phase 2
Completed NCT04504916 - A Study of Zilovertamab Vedotin (MK-2140) (VLS-101) in Participants With Solid Tumors (MK-2140-002) Phase 2
Completed NCT03345485 - Study of the Safety, Pharmacokinetics and Efficacy of EDO-S101, in Patients With Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT04582955 - Neoadjuvant Treatment of Early Triple-negative Breast Cancer With Chidamide and Chemotherapy N/A
Terminated NCT04099277 - A Study of LY3435151 in Participants With Solid Tumors Phase 1
Withdrawn NCT01695057 - Vorinostat Before Surgery in Treating Patients With Triple-Negative Breast Cancer N/A
Terminated NCT01234532 - Entinostat and Anastrozole in Treating Postmenopausal Women With TNBC That Can Be Removed by Surgery Phase 2
Recruiting NCT03805399 - FUSCC Refractory TNBC Umbrella (FUTURE) Phase 1/Phase 2
Active, not recruiting NCT04129996 - A Trial of Camrelizumab in Combination With Nab-paclitaxel and Famitinib as a First Line Treatment in Patients With Unresectable Locally Advanced or Metastatic Immunomodulatory Triple Negative Breast Cancer(FUTURE-C-PLUS) Phase 2
Terminated NCT03621982 - Study of ADCT-301 in Patients With Selected Advanced Solid Tumors Phase 1
Recruiting NCT05336721 - A Phase II Study of Chiauranib in Combine With Capecitabine in TNBC Phase 2
Terminated NCT03674827 - Vaccine-Based Immunotherapy Regimen For NSCLC and TNBC Phase 1
Completed NCT04177108 - A Study of Ipatasertib in Combination With Atezolizumab and Paclitaxel as a Treatment for Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer Phase 3