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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05205200
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