NCT04858529招募中3 期
Neoadjuvant TCHP Versus THP in Patients With Human Epidermal Growth Factor Receptor 2-positive Breast Cancer (neoCARHP) : a Randomized, Open-label, Multicenter, Phase III Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 774
- 试验地点
- 1
- 主要终点
- pathological complete response(ypT0/is,ypN0, pCR)
研究概览
简要总结
The neoCARHP study was a randomized, open-label, multicenter, phase III, neoadjuvant trial. This study aimed to compare the efficacy and safety of TCHP with THP neoadjuvant setting for HER2-positive breast cancer. Patients will be randomized at a 1:1 ratio into TCHP or THP, respectively, and will be treated every 3 weeks before surgery.The primary endpoint was the percentage of pCR (ypT0/is, ypN0), which was defined as the absence of any residual invasive cancer in both the breast and axillary lymph nodes.
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
- •To take part in the trial, patients must be aged > 18 years old and supply a signed informed consent form.
- •Patients must also have breast cancer meeting the following criteria:
- •Histologically confirmed invasive breast carcinoma
- •Clinical stage II-IIIC at presentation. HER2-positive breast cancer scored as 3+ by immunohistochemistry (IHC) in > 10% of immunoreactive cells, or HER2 gene amplification (ratio of HER2 gene signals to centromere 17 signals ≥2.0) by in situ hybridization (ISH).
- •Known hormone receptor status (ER and PR). Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or
- •Completed all necessary baseline laboratory and radiologic examinations prior to randomization.
- •Baseline left ventricular ejection fraction (LVEF)≥55% measured by echocardiography (ECHO).
- •Women who are not postmenopausal (≥12 months of amenorrhea) or surgically sterile (absence of ovaries and/or the uterus) must agree to remain abstinent or to use one highly effective form of non-hormonal contraception or two effective forms of non-hormonal contraception during the treatment period and for at least 6 months after the last dose of study treatment.
- •Clinical diagnosis of Alzheimer's Disease. Must be able to swallow tablets. All patients must be able to comply with the study protocol, according to the investigator's judgment.
排除标准
- •Stage IV (metastatic) breast cancer Inflammatory breast cancer Previous anti-cancer therapy or radiotherapy for any malignancy. A history of other malignancies, except for carcinoma in situ of the cervix or squamous or basal cell carcinoma.
- •Concurrent anti-cancer treatment in another clinical trial, including hormone therapy, bisphosphonate therapy, or immunotherapy.
- •Received a major non-breast cancer-related surgical procedure within the 4 weeks before randomization or from which the patient has not fully recovered.
- •A serious cardiac illness or medical condition, including but not limited to the following:
- •Documented history heart failure or systolic dysfunction (LVEF < 50%). High-risk uncontrolled arrhythmia, such as atrial tachycardia with a heart rate >100 bpm at rest, significant ventricular arrhythmia (e.g., ventricular tachycardia), or higher-grade atrioventricular (AV) block (i.e., Mobitz II second-degree AV block or third-degree AV block).
- •Angina pectoris requiring anti-angina medication. Clinically significant valvular heart disease. Evidence of transmural infarction on ECG Poorly controlled hypertension (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg) Other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness.
- •Any of the following abnormal laboratory tests immediately prior to randomization:
- •Total bilirubin > 1.5 × upper limit of normal (ULN) or, for cases of known Gilbert's syndrome, total bilirubin > 2 × ULN Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 1.25 × ULN Alkaline phosphatase > 2.5 × ULN Serum creatinine > 1.5 × ULN Total white blood cell (WBC) count < 2500 cells/uL Absolute neutrophil count <1500 cells/uL Platelet count <100,000 cells/uL Sensitivity to any of the study medications, any of the ingredients or excipients of these medications, or benzyl alcohol Pregnant or lactating: a negative serum pregnancy test is required for all women who are not postmenopausal (≥ 12 months of amenorrhea).
- •Insulin dependent diabetes. Thyroid disease.
研究组 & 干预措施
THP
Experimental
干预措施: investigator-selected taxane/trastuzumab/pertuzumab (THP) (Drug)
TCHP
Active Comparator
干预措施: investigator-selected taxane/carboplatin/trastuzumab/pertuzumab (TCHP) (Drug)
结局指标
主要结局
pathological complete response(ypT0/is,ypN0, pCR)
时间窗: 18 weeks
defined as the absence of invasive tumor cells in breast and axilla, ypT0/is ypN0
次要结局
- Clinical response during neoadjuvant therapy(18 weeks)
- The percentage of patients who underwent breast-conserving surgery(18 weeks)
- Safety Outcome Measures(until disease progression or recurrence or until 5 years after randomization of the last patient, which ever occurs first.)
- Event-free survival (EFS)(until disease progression or recurrence or until 5 years after randomization of the last patient, which ever occurs first.)
- Disease-free survival (DFS)(until disease progression or recurrence or until 5 years after randomization of the last patient, which ever occurs first.)
- Overall survival, defined as the time from randomization to death from any cause.(from randomization to death from any cause.)
研究者
Kun Wang
M.D.
Guangdong Provincial People's Hospital
研究点 (1)
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