Fact CheckerSign in

NCT06355024CompletedPhase 2

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

Source: ClinicalTrials.gov · Last updated 18 Jul 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
10 (actual)
First submitted
30 Mar 2024
Start date
11 May 2024
Primary completion date
1 Jan 2025
Lead sponsor
Fudan University
NCT number
NCT06355024

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 10
  • From 11 May 2024 to the primary completion date, 1 Jan 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Treatment with chemotherapy, radiotherapy,immunotherapy or surgery (outpatient clinic surgery excluded) within 3 weeks prior to initiation of study treatment.
  • 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

Other illness

  • 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
  • History of allergies to the drug components of this trial

Other

  • Symptomatic, untreated, or actively progressing CNS metastases
  • Pregnancy or breastfeeding, or intention of becoming pregnant during the study

Who the study is looking for

  • \- 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

Age in the registry: 18 years to 70 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
breast cancer institute of Fudan University Cancer Hospital
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.