Phase II study of FEC followed by Nab-paclitaxel as Neoadjuvant Chemotherapy for Primary Breast Cancer

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2012
INTERVENTION: 4 cycles of FEC followed by 4 cycles of nab‐paclitaxel FEC Epi‐ADM 90 mg/m2 and CPA 600 mg/m2 iv,day 1 every 3 weeks Nab‐paclitaxel Nab‐paclitaxel:100mg/m2 intravenously administred on day 1,8,15 every 4 weeks CONDITION: Breast cancer PRIMARY OUTCOME: Pathological complete response rate SECONDARY OUTCOME: Pathological response rate,Rasponse rate,Safty INCLUSION CRITERIA: 1.Histologically confirmed Breast cancer 2. Clinical stage2‐4 3. Expected to radical cure by operation and neoadjuvant chemotherapy 4. Has measurable region 5. Age >=20 6.No prior surgery, radiation, chemotherapy and endcrinethrapy 7.Required baseline laboratory parameters (within 14 days before registration): Hb more than 9.0g/dl WBC >= 3500 /mm3 and <= 12,000 /mm3 Neu >= 2000 / mm3 Plt >= 100,000/mm3 T‐Bil <= 2 times ULM AST<= ULNx2 ALT<= ULNx2 Creatinin <=1.5 mg/dL Ccr <=50 ml/min 8.Performance status 0‐1 9. Oral administration is available 10.Written IC
Epistemonikos ID: 54fe9959c54da29e6905a4c401932e431325e91e
First added on: Aug 22, 2024