Phase II study of weekly nanoparticle albumin-bound paclitaxel for patients with metastatic breast cancer (KSCOG-BC04)

Authors [No authors listed]
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2012
Links
INTERVENTION: Nab‐paclitaxel 100mg/m2 on days 1, 8, 15 Nab‐paclitaxel 100mg/m2 on days 1, 8, 15 Trastuzumab* : 2mg/kg , Day 1, 8, 15, 22 *4 mg/kg for the initial dosing (day 1) Cycles are repeated every 4 weeks. CONDITION: Breast Cancer PRIMARY OUTCOME: Response Rate INCLUSION CRITERIA: 1) Written informed consent to participate 2) Suitable judgement by physician 3) Histological and/or cytological confirmed breast cancer 4) Metastatic breast cancer 5) The below criteria are met about prior therapy a. chemotherapy: more than 14 days passed after prior chemotherapy. b. hormonal therapy: more than 7 days passed after hormonal therapy c. radiation: more than 14 days passed after radiation. 6) Age 20 or over 7) Performance status (ECOG) 0‐2 8) Has measurable lesion with CT within 28 days according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 9) The below criteria met within 14 days prior to therapy 1.WBC between 3,000/mm3 and 12,000/mm3 2.Granulocyte count 1,500/mm3 or over 3.Platelet count 100,000/mm3 or over 4.Hb 9.0 g/dl or over 5.Total bilirubin 2.0 mg/dL or under 6.AST(GOT) 100 IU/L or under 7.ALT(GPT) 100 IU/L or under 8.Serum creatinine 1.5 mg/dl or under 9.(
Epistemonikos ID: 73ac7c742b48eff54791928de4e50671d2181e49
First added on: Aug 22, 2024