Phase II Study of Primary Paclitaxel Plus Gemcitabine in Patients With Stage II and III Breast Cancer
Patients will be treated as follows:
PG x 4®operation®AC x 4®radiation ± tamoxifen/AI(postmenopausal)
Intravenous infusion of Paclitaxel 80 mg/m2, over 60 min, on D1 and D8 Followed by
intravenous infusion of Gemcitabine 1200 mg/m2, over 30 min, on D1 and D8
The cycle repeats every 3 weeks for 4 times. Premedication includes antiemetics,
dexamethasone, famotidine, pheniramine as routinely given.
After the operation, standard adjuvant chemotherapy (doxorubicin 60 mg/m2, cyclophosphamide
600 mg/m2, every 3 weeks x 4 cycles) will be given.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the clinical and pathologic responses to preoperative administration of Paclitaxel/Gemcitabine (PG)
Jungsil Ro, MD, PhD
National Cancer Center
South Korea: Korea Food and Drug Administration (KFDA)