Inosine Reverse Chemo Resistance in Triple Negative Breast Cancer

NCT06355024 | Completed Phase 2

• 1 other identifier: A2024.1.30
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Triple-negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Baseline until disease progression or loss of clinical benefit, assessed up to 6 months

Secondary Outcomes (4)

• Disease Control Rate (DCR)

  Baseline through end of study, assessed up to 6 months

• Progression Free Survival (PFS)

  Randomization to death from any cause, through the end of study,assessed up to 6 months

• Biomarker analysis1

  Baseline until disease progression or loss of clinical benefit, assessed up to 6 months

• Safety and treatment-related AEs

  Randomization to death from any cause, through the end of study,assessed up to 12 months

Study Arms (1)

Inosine

EXPERIMENTAL

oral inosine arm

Drug: Inosine; Drug: Taxane/Anthracycline/Eribulin Mesylate/Vinorelbine/Capecitabine/Carboplatin/UTD1/platinum

Interventions

Inosine DRUG

oral inosine 200mg tid

Inosine

Taxane/Anthracycline/Eribulin Mesylate/Vinorelbine/Capecitabine/Carboplatin/UTD1/platinum DRUG

Taxane/Anthracycline/Eribulin Mesylate/Vinorelbine/Capecitabine/Carboplatin/UTD1/platinum

Inosine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

breast cancer institute of Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Inosine; taxane

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 30, 2024
• First Posted: April 9, 2024
• Study Start: May 11, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: July 18, 2025

Record last verified: 2025-07

Locations

CN (1)