Randomized Phase III Non-inferiority Study Comparing Two Steroid Premedication Strategy For Weekly Paclitaxel Chemotherapy in Patients with Breast Cancer
- Conditions
- Neoplasms
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 374
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method All grade infusion-related reaction incidence
- Secondary Outcome Measures
Name Time Method Grade 3 or more infusion-related reaction incidence;endocrinologic toxicity incidence