NCT00550771已完成2 期
Randomized Phase II Multinational Trial to Evaluate the Safety of Two Chemotherapy Plus Trastuzumab Regimens as Adjuvant Therapy in Patients With HER2-positive Breast Cancer: Caelyx + Cyclophosphamide + Trastuzumab (C+C+H) or Doxorubicin + Cyclophosphamide (A+C), Each Followed by Paclitaxel + Trastuzumab (T+H) BACH
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 181
- 主要终点
- Number of Participants Who Experienced Cardiac Events (Level 1 or 2), or Inability to Administer Trastuzumab Either During the 8 Cycles of Chemotherapy or According to Package Insert for a Total Duration of 1 Year
研究概览
简要总结
The purpose of this study is to compare the incidence of cardiac dysfunction in subjects with human epidermal growth factor receptor 2 (HER2) positive breast cancer treated with either doxorubicin or pegylated liposomal doxorubicin (PLD), both in combination with trastuzumab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subjects with operable, node-positive or high-risk node-negative (see #3 below) HER2-positive breast carcinoma are eligible for the study, provided they satisfy the following criteria.
- •Subjects must demonstrate willingness to and be able to participate in the study and to adhere to dose and visit schedules
- •Subjects must be of female gender and >= 18 years of age
- •Subjects must have been diagnosed with operable, histologically confirmed adenocarcinoma of the breast with no clinical or radiological evidence of metastatic disease but with otherwise high or intermediate risk tumor characteristics:
- •node-positive: T1-3, N1-2, M0 (level of T [tumor involvement], N [lymph node involvement], & M [matastases]) OR
- •node-negative AND at least one of the following features:
- •Tumor >2 cm or
- •Tumor >1 cm and
- •Negative estrogen receptor/progesterone receptor (ER/PR) or
- •Malignancy Grade 2-3 or
- •Presence of peritumoral vascular invasion or
- •Age <35 years
- •HER2-positive by fluorescence in situ hybridization (FISH)(with gene amplification) or 3+ using
- •immunohistochemistry
- •Subjects must have had complete resection (R0) of the primary tumor and axillary lymph nodes (or must have negative sentinel node[s])
- •Baseline left ventricular ejection fraction (LVEF) by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO) >=55%
- •Easter Cooperative Oncology Group (ECOG)-performance status of 0-1
- •Adequate postoperative bone marrow function with neutrophils >=1.5 x 10^9/l, platelets >=100 x 10^9/l and hemoglobin >= lower limit of normal (LLN)
- •Adequate renal function: calculated creatinine clearance >=50 ml/min
- •Adequate postoperative liver function with a total bilirubin < upper limit of normal (ULN), alkaline phosphatase <2.5 times the ULN and aspartate aminotransferase (AST) <1.5 times the ULN
- •Subjects must be free of any clinically relevant disease that would, in the principal investigator's and/or sponsor's opinion, interfere with the conduct of the study or study evaluations
- •Subjects of childbearing potential (including women who are less than one year postmenopausal and will be sexually active during the study) must agree to use a medically accepted method of contraception, while receiving protocol-specified medication and for 30 days (or as per local requirements) after stopping the medication or be surgically sterilized prior to screening
- •Subjects must be able to provide written informed consent
排除标准
- •Subject who meets any of the following exclusion criteria will be disqualified from participation in the study:
- •Clinical or radiological evidence of metastatic disease
- •Prior radiotherapy, chemotherapy or biotherapy for the currently diagnosed breast cancer prior to randomization
- •Clinically significant pericardial effusion
- •Serious cardiac illness including, but not confined to
- •history of documented congestive heart failure
- •history of any form of cardiomyopathy or active treatment for any form of cardiomyopathy
- •history of angina pectoris or documented transmural myocardial infarction, or active angina pectoris requiring medication
- •serious ventricular arrhythmias requiring medication or implantable cardioverter-defibrillator (ICD) therapy, uncontrolled supraventricular arrhythmias
- •clinically significant valvular disease
- •poorly controlled arterial hypertension (systolic blood pressure (BP) >180 mmHg, diastolic BP >100 mmHg)
- •Sensory/motor neuropathy > grade 2 as defined by National Cancer Institure - Common Toxicity Criteria (NCI-CTC)
- •Pregnancy, or intending to become pregnant during the study
- •Nursing (breastfeeding) or intending to be nursing during the study
- •Any of the following clinical conditions:
- •Chronic obstructive pulmonary disease, requiring chronic treatment
- •Clinically significant active infections
- •A history of a psychological illness of condition, preventing the subject to understand the requirements of the study
- •Unstable regulation of diabetes mellitus
- •A situation or condition that, in the opinion of the investigator, may interfere with optimal participation in the study
- •Is on staff, affiliated with, or a family member of the staff personnel directly involved with this study
- •Usage of any investigational product within 30 days prior to enrollment
- •Participation in any other interventional clinical study involving drug, device or biological. This would not prohibit the patient from participating in a quality of life (QOL), questionnaire, blood collection, or observational study.
- •Allergy to or sensitivity to the study drug or its excipients
研究组 & 干预措施
Doxorubicin Based Regimen
Active Comparator
干预措施: doxorubicin, cyclophosphamide, paclitaxel, trastuzumab (Drug)
Pegylated Liposomal Doxorubicin (PLD) Based Regimen
Experimental
干预措施: PLD, cyclophosphamide, trastuzumab, paclitaxel (Drug)
结局指标
主要结局
Number of Participants Who Experienced Cardiac Events (Level 1 or 2), or Inability to Administer Trastuzumab Either During the 8 Cycles of Chemotherapy or According to Package Insert for a Total Duration of 1 Year
时间窗: 8 cycles of chemotherapy and subsequently one year of planned trastuzumab treatment
Cardiac events defined as: Level 1: Cardiac death due to heart failure (HF), myocardial infarction or arrhythmia, or probable cardiac death defined as sudden, unexpected death within 24 hours of a definite or probable cardiac event, or severe symptomatic HF, concomitant with a left ventricular ejection fraction (LVEF) drop of \>10 percentage points from baseline and to ≤50% LVEF Level 2: Asymptomatic systolic dysfunction or mildly symptomatic HF concomitant with an LVEF drop of \>10 percentage points from baseline and to \<50% LVEF; the LVEF drop was to have been confirmed within 3-4 weeks.
次要结局
- Number of Participants Who Experienced Cardiac Events (Level 1 or 2) or Inability to Administer Trastuzumab During 1 Year of Trastuzumab Therapy(During 1 year of trastuzumab therapy)
- Number of Participants Who Survived Without Relapse(Approximately 2 years)
- Number of Participants Who Experienced Cardiac Events (Level 1 or 2) or Inability to Administer Trastuzumab During the 8 Cycles of Chemotherapy(During the 8 courses of chemotherapy)
研究者
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