Randomized Phase III Non-inferiority Study Comparing Two Steroid Premedication Strategy For Weekly Paclitaxel Chemotherapy in Patients with Breast Cancer

Yonsei University Health System, Severance Hospital0 个研究点目标入组 374 人开始时间: 待定最近更新: 2023年1月10日

适应症

试验速览

暂无简介。

•1. Age > 18
•2. ECOG 0 or 1
•3. Patient who will be treated with weekly paclitaxel for 12 weeks as neoadjuvant or adjuvant therapy for invasive breast cancer
•4. stage II or III
•5. HER2(human epidermal growth factor receptor 2) negative breast cancer
•HER2 negative is defined as IHC 0, 1+ or ICH 2+ and ISH negative
•6. Adequate organ function
•-Hb: = 9.0 g/dl
•-ANC: = 1,500 / µl
•-Platelet: = 7.5 × 104/ µl
•-Creatinine: = 1.5 x UN
•-Creatinine clearance (Ccr) = 50 ml/min by Cockroft-Gault formula
•-Total Bilirubin: = 1.5 × UNL
•-AST/ALT: = 2.5 × UNL
•7. Informed consent

•1. Metastatic breast cancer
•2. Inflammatory breast cancer
•3. Previous chemotherapy (AC(Adriamycin and Cyclophosphamide) chemotherapy before paclitaxel is allowed)
•4. uncontrolled Diabetes Mellitus
•5. Patients who are treating for abnormal hypothalamus and adrenal function.
•6. Steroid treatment for 1 month or more within 3 months (steroid for antiemetics during AC chemotherapy is allowed)
•7. Infusion related reaction for paclitaxel, or a drug substance (including Cremorphor), Dexamethasone, Peniramin, and Cimetidine
•8. NCI-CTCAE(National Cancer Institute - Common Terminology Criteria for Adverse Events) 4.03 grade = 2 peripheral neuropathy
•9. Severe cardiopulmonary dysfunction, uncontrolled infection, or serious medical condition
•10. Pregnant and breast feeding women
•11. Patient who are not adequate for this trial by judgement of investigator

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