RecruitingPhase 2NCT06851299

The Clinical Study of the Efficacy and Safety of Trop2-ADC Monotherapy or Combination Immunotherapy Strategy in the Treatment of Advanced Triple-negative Breast Cancer.

Randomized Controlled Clinical Study of Efficacy and Safety of Trop2-ADC Monotherapy or Combination Immunotherapy Strategies in the Treatment of Advanced Triple-negative Breast Cancer


Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Enrollment

60 participants

Start Date

Mar 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a prospective, multicenter, randomized controlled study aimed at evaluating the efficacy and safety of Trop2-ADC monotherapy or immune combination strategy in the treatment of advanced triple-negative breast cancer.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called Trop2-ADC (a targeted therapy that delivers chemotherapy directly to cancer cells via a protein called Trop2), used either alone or in combination with immunotherapy, in women with advanced triple-negative breast cancer (TNBC — a type of breast cancer that does not respond to hormone or HER2-targeted treatments). **You may be eligible if...** - You are a woman between 18 and 70 years old - You have metastatic triple-negative breast cancer confirmed by pathology or imaging - You have received no more than two prior lines of treatment for metastatic disease - Your performance status (ability to carry out daily activities) is adequate (ECOG 0–2) - Your expected survival is at least 3 months - You have at least one measurable tumor visible on imaging **You may NOT be eligible if...** - You have had more than two prior lines of therapy for metastatic disease - Your performance status is poor (ECOG 3 or higher) - You have uncontrolled brain metastases - You have serious heart, liver, or kidney problems - You are pregnant or breastfeeding 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

DRUGtrop2-ADC

Accept ADC monotherapy

DRUGADC +anti-angiogenic drug

Accept ADC combined with anti-angiogenic drug

DRUGADC + PD1 monoclonal antibody +anti-angiogenic drug

ADC combined with PD1 monoclonal antibody and anti-angiogenic drug


Locations(1)

Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China;

Guangzhou, Guangdong, China

View Full Details on ClinicalTrials.gov

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

Visit

NCT06851299


Related Trials