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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0003651

Enrollment

374

Registered

2019-03-21

Start date

2023-03-01

Completion date

Unknown

Last updated

2023-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Paclitaxel 80mg/m2 IVF for 1 hour 1. Standard arm Pre-medication is given at 30 min before paclitaxel chemotherapy 1) Dexamethasone 10mg IV 2) Peniramine 4mg IV 3) Cimetidine 400mg IV 2. Exp

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
All grade infusion-related reaction incidence	—

Secondary

Measure	Time frame
Grade 3 or more infusion-related reaction incidence;endocrinologic toxicity incidence	—

Countries

Korea, Republic of

Contacts

Public ContactGun Min Kim

Yonsei University

gmkim77@yuhs.ac+82-2-2228-8127

Outcome results