KCT0004843尚未招募未知
S1501 Prospective Evaluation of Carvedilol in Prevention of Cardiac Toxicity in Patients with Metastatic HER-2+ Breast Cancer, Phase III”
ational Cancer Center0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18?(Year) 至 o Limit（—）
- 性别
- Female
入选标准
- •STEP 1 REGISTRATION
- •Patients must have metastatic breast cancer and be initiating within 11 days of step 1 registration or continuing trastuzumab?based HER-2 targeted therapy without concurrent anthracyclines in first or second, third or forth line setting; patients may have brain metastasis; there is no limit for number of doses of HER-2 targeted therapy prior to registration; examples of eligible HER-2 targeted therapy:
- •Trastuzumab
- •Trastuzumab + chemotherapy or hormonal therapy
- •Trastuzumab + other HER-2 targeted agent with or without chemotherapy (such as pertuzumab,lapatinib, and tucatinib)
- •Ado-trastuzumab (Kadcyla)
- •Fam-trastuzumab deruxtecan(Enhertu)
- •NOTE: Patients on lapatinib without trastuzumab are not eligible; planned treatment with concurrent HER-2 targeted therapy and anthracyclines is not permitted
- •Patients must be at increased risk for cardiotoxicity defined by at least one of the following:
- •a.Previous anthracycline exposure, OR
- •1 or more of the following risk factors for heart disease:
- •Left ventricular ejection fraction (LVEF) 50-54% by local echocardiography (ECHO) read
- •Age >= 65
- •Body mass index (BMI) >= 30 kg/m^2
- •Current or prior anti-hypertensive therapy
- •Diagnosis of coronary artery disease (CAD)
- •Diabetes mellitus
- •Atrial fibrillation/flutter
- •2.Patients must not have taken within 21 days prior to step 1 registration, be currently taking at the time of step 1 registration, or planning to take once registered to step 1 a beta blocker, ARB, or ACE inhibitor in order to be randomized (Arms 1 and 2)
- •Patients currently taking a beta blocker, ARB, or ACE inhibitor at the time of step 1 registration are eligible to register for the non-randomized observational cohort (Arm 3)
- •3.Patients must not be currently taking or planning to take during study treatment the following medications:
- •B2 agonists
- •Floctafenine
- •Methacholine
- •Rivastigmine
- •Vincristine
- •Patients must have a Zubrod Performance status of 0-2
- •Patients must have a complete physical examination and medical history within 28 days prior to registration
- •Patients must have LVEF >= 50% by 2-dimensional (D) echocardiogram within 28 days prior to registration; the echocardiogram must be obtained from a S1501 validated ECHO laboratory (lab) and submitted for central review by the S1501 ECHO core lab; ECHO should not be submitted for central read until patient has been otherwise deemed eligible
- •Serum bilirubin < 3.0 x institutional upper limit of normal (IULN)
- •Serum glutamic oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST) and serum glutamic pyruvic transaminase (SGPT)/alanine aminotransferase (ALT) < 5.0 x IULN
- •Patients must have a systolic blood pressure >= 90 mm Hg within 14 days prior to registration
- •Patients must not be dialysis dependent
- •Patients must be able to swallow tablets
- •Patients must not have uncontrolled asthma
- •No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, prostate cancer on active surveillance, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years
- •Patients must not be pregnant or nursing due to potential fetal or nursing infant harm; women/men of reproductive potential must have agreed to use an effective contraceptive method, a woman is conside
排除标准
- •state inclusion criteria
研究者
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