KCT0008323进行中（未招募）未知
Phase II study of Neo-adjuvant chemotherapy with letrozole in patients with estrogen receptor positive/HER-2 negative breast cancer
ational Cancer Center0 个研究点目标入组 114 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 114
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
- 19(Year) 至 70(Year)（—）
- 性别
- All
入选标准
- •1 Locally advanced breast cancer patients with histological confirmation
- •2 Age =19 and =70
- •3 ER or PR positive, cT2N0 or cTx/N+ M0 (ER-positive =1% nuclear staining by immunohistochemistry , Allred score=3 )
- •4. Histological specimen (FFPE) should be present at diagnosis, and when examined from a different hospital, slides for ER, PR, HER2, and KI67 immunohistochemistry analysis as well as 5 unstained slides need to be present
- •5. Patients has hitologically and/or cytologically confirmed diagnosis of HER2-negative breast cancer
- •6 Patients with at least one measurable lesion by RECIST 1.1 from the images
- •7. Women of childbearing age should agree to proper contraception during the trial period (from the beginning until a few hours or a few days after the last administration of drugs considering half-life)
- •8 Patients with ECOG activity of 0,1, or 2
- •9 Patients with proper organ functions (attachment A)
- •10 Patients who signed the consent form
排除标准
- •1. Patients with inflammatory breast cancer
- •2. Patients with bliateral breast cancer
- •3.Patients with stroke including transient ischemic attack, pulmonary artery thrombosis or deep vein thrombosis untreated within 6 months: study participation is available when there are no symptoms after the administration of therapeutic anticoagulant for 6 weeks or longer within 6 months
- •4. Patients with a history of previous malignant tumor. However, the following patients are exempted from the exclusion criteria
- •4.1 Patients with 3 years of disease free survival with malignant tumor different from the current tumor
- •4.2 Patients with skin tumor excluding melanoma that had complete resection
- •4.3 Patients with early gastric cancer that had radical resection
- •5.Patients with differentiated thyroid cancer of less than 1 cm
- •6. Patients whose ejection fraction is less than 55% in the MUGA scan /EchoCG
- •7. Patients without properly conserved tissue samples for diagnostic histological analysis (5 unstained slides excluding ER, PR, HER2, KI67)
- •8. Patients with clinically significant gastrointestinal bleeding – including but not limited to following conditions
- •8.1 Active peptic ulcer
- •8.2 Inflammatory intestinal disease
- •8.3 Patients with other gastrointestinal disease with a risk of perforation, gastrointestinal perforation or fistula, or a history of intraperitoneal abscess
- •9. Patients who cannot be administered with anthracycline due to other heart disease
- •10. Patients with clinically significant gastrointestinal malabsorption – including but not limited to the following conditions
- •10.1 Malabsorption syndrome
- •10.2 History of receiving major resection on stomach or small intestine
- •11 Corrected QT interval of ECG > 480 msec
- •12 Patients who have experienced the following cardiovascular abnormalities within the past 6 months
- •12.1 Patients who received coronary angioplasty or stent insertion
- •12.2 Acute myocardial infarction
- •12.3 Unstable angina
- •12.4 Patients who received coronary artery bypass surgery
- •12.5 Patients with symptomatic peripheral arterial disease
- •13 NYHA class III or IV congestive heart failure (Attachment B)
- •14 Uncontrolled hypertension (systolic blood pressure =140 mmHg or diastolic blood pressure =90 mmHg)
- •15 Patients who had a major surgery or trauma, and/or unhealed injury, fracture, and ulcer within 28 days before the administration of the first test drug: manipulations such as catheter insertion are not included in a major surgery
- •16 Acute hemorrhage or hemorrhagic tendency
- •17 Patients with a risk of pulmonary hemorrhage due to a lesion in the airway or a lesion invading the major pulmonary arteries; patients can participate in the trial when the tumor is in contact with blood vessels but has not invaded
- •18 Patients with protruding lesions in the main bronchi and lobar bronchi are excluded. Patients with lesions in the segmental bronchi can participate in the trial
- •19 Patients who recently had hemoptysis (within 8 weeks of the first administration of test drugs, ½ teaspoon of hemoptysis)
- •20 Administration of non-tumor clinical trial drug within 30 days of the first administration of test drugs or within 5 times of drug half-life
- •21 Pregnant women
研究者
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