In HER2-positive ER-negative breast cancer with gene HSD17B4 hyperMethylation Prospective study Evaluating the usefulness of non-Surgical therapy

未提供0 个研究点目标入组 250 人开始时间: 2024年9月18日最近更新: 2025年6月18日

适应症

试验速览

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•Histologically confirmed invasive breast cancer, excluding invasive breast cancer with a predominant non-invasive component
•Clinical T3 or lower on physical examination and imaging studies within 56 days prior to enrollment
•Clinical stage N1 or lower on physical examination and imaging studies within 56 days prior to enrollment. Cytological or histological confirmation is not mandatory.
•Non-metastatic operable breast cancer
•HER2 positive breast cancer
•Estrogen receptor negative
•Women aged 20 years or older on the date of enrollment
•Eastern Cooperative Oncology Group performance status of 0 to 1
•No previous treatment with chemotherapy, endocrine therapy, anti-HER2 therapy and radiotherapy to the breast or chest
•No previous history of non-invasive or invasive breast cancer
•Left ventricular ejection fraction by echocardiogram or multigated acquisition scan of 55% and higher within 56 days prior to enrollment
•Preserved organ functions within 28 days prior to enrollment
•Signed written informed consent

•History of other malignancy within the last 5 years
•History of congestive heart failure, myocardial infarction. Concurrent arrhythmia or heart valvular disease requiring treatment
•Current uncontrolled infections
•Current pregnancy and/or lactation, possible pregnancy and within 28 days postpartum
•Current uncontrolled diabetes mellitus
•Current scleroderma and systemic lupus erythematosus
•Current treatment with systemic steroids or immune suppressive agents
•Unsuitable mental status for participation
•Complications of interstitial pneumonia, pulmonary fibrosis or severe emphysema

3-year distant metastasis free survival

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发起方

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