RecruitingPhase 2NCT06731140

Reverse HER2-negative Immune Resistant Breast Cancer


Sponsor

Fudan University

Enrollment

10 participants

Start Date

Feb 12, 2025

Study Type

INTERVENTIONAL

Summary

This is a Phase II, open-label study evaluating the efficacy and safety of combined treatment (retinoic acid) with immune checkpoint inhibitor in HER2-negative breast cancer patients who progressed during previous immune checkpoint inhibitors.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing treatments to help overcome resistance to immunotherapy in people with metastatic or locally advanced breast cancer — specifically hormone receptor-positive (luminal) or triple-negative breast cancer — whose cancer has stopped responding to immunotherapy. **You may be eligible if...** - You have metastatic or locally advanced breast cancer (either hormone receptor-positive HER2-negative, or triple-negative) - Your cancer progressed or stopped responding to immunotherapy (combined with targeted therapy or chemotherapy) - You are in reasonably good functional health - Your organ function (blood, liver, kidneys) is adequate **You may NOT be eligible if...** - You have HER2-positive breast cancer - You have not received prior immunotherapy - You have serious active infections, autoimmune conditions, or other significant health issues - 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.

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Interventions

DRUGRetinoic Acid

Retinoic acid 20mg tid, p.o.

DRUGanti-PD-1 antibody and chemotherapy

PD-1 antibody SHR1210 200mg q2w chemotherapy (whether and which should be given depends on the treatment regimen before enrollment)


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT06731140