A Randomized Study to Investigate the Efficacy and Safety of qw or q3w Trastuzumab, Paclitaxel and Carboplatin in Patients With IIB-IIIB HER2 Positive Breast Cancer
Currently Herceptin has moved to Neoadjuvant treatment combined with chemotherapy.
Paclitaxel and Carboplatin are two of the best partners with high pCR. The significant
efficacy and good safety profile of Herceptin® combination with taxane as adjuvant treatment
on EBC are accepted; 1 year of Herceptin as adjuvant treatment is one standard therapy. This
study is one small Phase II trial to explore the efficacy and safety of QW and Q3W of PCH as
Neoadjuvant treatment, we only plan 60 pts and the trend of the two curves is anticipated
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary Endpoint is efficacy. To compare the efficacy in terms of the pathological complete response rate (pCR) to preoperative administration of qw or q3w Paclitaxel, Carboplatin and Trastuzumab (PCH).
Primary Endpoint is efficacy. To compare the efficacy in terms of the pathological complete response rate (pCR) to preoperative administration of qw or q3w Paclitaxel, Carboplatin and Trastuzumab (PCH). The primary efficacy variable is the rate of pathological complete response (pCR). Time to recurrence will be measured as the time from when the patient was randomized to the time the patient is first recorded as having disease recurrence or the date of death if the patient dies due to causes other than disease recurrence.
3 years from last patient randomized
Zhimin Shao, Post-Doctor
Cancer Hospital Affiliated to Fudan University
China: Food and Drug Administration