RecruitingNot ApplicableNCT06371274

A Study on the Efficacy and Safety of Oral All-trans Retinoic Acid Combined With Toripalimab in TNBC.

Efficacy and Safety Study of Oral All-trans Retinoic Acid Combined With Toripalimab in Patients With Inoperable Locally Advanced, Recurrent, or Metastatic Triple-negative Breast Cancer Who Had Failed Prior Second-line or Higher Standard Therapy.

Sponsor

First Affiliated Hospital of Zhejiang University

Enrollment

29 participants

Start Date

Oct 10, 2024

Study Type

INTERVENTIONAL

Summary

To evaluate the clinical efficacy and safety of oral all-trans retinoic acid in combination with toripalimab in patients with locally advanced, recurrent, or metastatic triple-negative breast cancer who had failed second-line and subsequent therapy.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing the combination of two drugs — all-trans retinoic acid (a vitamin A-derived compound) and toripalimab (an immunotherapy) — for people with triple-negative breast cancer (a type with fewer targeted treatment options) that has spread or cannot be surgically removed and has stopped responding to previous treatments. **You may be eligible if...** - You are 18 or older with confirmed triple-negative breast cancer - Your cancer is unresectable (cannot be removed surgically) or metastatic (has spread) - You have already tried at least two prior standard treatment regimens that didn't work - You have at least one measurable tumor on imaging **You may NOT be eligible if...** - Your only measurable disease is in the skin or bones - You have had a recent blood transfusion or growth factor treatment within 2 weeks before screening - You have poor organ or bone marrow function Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGATRA

ATRA is the main active metabolite of vitamin A. Studies have shown that ATRA can also reduce the number of MDSC in solid tumor patients, promote their differentiation and maturation, remove the immunosuppressive ability of MDSC, improve the tumor immune microenvironment, and thus improve the tumor treatment efficacy.

DRUGToripalimab

Toripalimab is a fully human monoclonal antibody injection against PD-1 receptor. The NMPA has accepted the application of Toripalimab for a new indication for the treatment of initial metastatic or relapsed metastatic TNBC with PD-L1 positive (CPS≥1).

Locations(1)

The first affiliated hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang Province, P.R. China, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06371274