Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06355024
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-09
First Post:
2024-03-30
Brief Title:
Inosine Reverse Chemo Resistance in Triple Negative Breast Cancer
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
a Pilot Study to Explore the Efficacy of Inosine Reversing Chemo Resistance in Triple Negative Breast Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase II open-label single-arm study evaluating the efficacy and safety of combined treatment of Inosine 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 Inosine with chemotherapy in metastatic TNBC triple negative breast cancer patients who progressed during or following 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 The preclinical results show that Inosine play a potentially important role in regulating the tumor microenvironment The investigators found that inosine from intestinal probiotics was negatively correlated with breast cancer recurrence and metastasis after chemotherapy and further functional experiments showed that inosine-producing flora or dietary supplementation with inosine could significantly inhibit the survival of tumor cells after chemotherapy and inhibit the recurrence and metastasis of breast cancer Furthermore it is considered to have a high level of safety 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 inosine with chemotherapy at a clinical level providing new strategies of combined treatment for TNBC patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None