RecruitingPhase 2NCT05205200

Immune Therapy in HR-positive/HER2-negative Metastatic Breast Cancer(ENIGMA)-BCTOP-L-M02

Immune Therapy in HR-positive/HER2-negative Metastatic Breast Cancer


Sponsor

Fudan University

Enrollment

338 participants

Start Date

Jun 6, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a prospective, open-label, phase II clinical study for patients with HR+/HER2- advanced breast cancer.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing immunotherapy combinations in women with a specific subtype of hormone receptor-positive, HER2-negative metastatic breast cancer — a subtype identified by a molecular profiling test called SNF-2. Researchers want to see if adding immunotherapy to standard hormone-blocking treatment improves outcomes. **You may be eligible if...** - You are a woman between 18 and 75 years old - You have been diagnosed with hormone receptor-positive (HR+), HER2-negative metastatic breast cancer - Your tumor is classified as SNF-2 subtype by specialized testing - Your cancer has progressed or you require a new line of treatment **You may NOT be eligible if...** - Your tumor is not the SNF-2 subtype - Your cancer is HER2-positive - You have active autoimmune disease - Your organ function is inadequate 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

DRUGSHR-1316

PD-L1 antibody

DRUGSHR6390

CDK4/6 inhibitor

DRUGNab paclitaxel

Albumin bound paclitaxel

DRUGSERD

Fulvestrant

DRUGAI

aromatase inhibitor


Locations(1)

Fudan University Shanghai cancer center

Shanghai, China

View Full Details on ClinicalTrials.gov

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NCT05205200


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