Clinical trial · Interventional
Inosine Reverse Chemo Resistance in Triple Negative Breast Cancer
a Pilot Study to Explore the Efficacy of Inosine Reversing Chemo Resistance in Triple Negative Breast Cancer
NCT06355024CI-TRIAL-00092309completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Triple-negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Inosine | Drug | — | UNRESOLVED |
| Taxane/Anthracycline/Eribulin Mesylate/Vinorelbine/Capecitabine/Carboplatin/UTD1/platinum | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Inosine
- description
- oral inosine arm
- interventionNames
- Drug: Inosine
- Drug: Taxane/Anthracycline/Eribulin Mesylate/Vinorelbine/Capecitabine/Carboplatin/UTD1/platinum
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- Baseline until disease progression or loss of clinical benefit, assessed up to 6 months
Secondary outcomes (4)
- measure
- Disease Control Rate (DCR)
- timeFrame
- Baseline through end of study, assessed up to 6 months
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.