Trial Information

Phase II Study of Primary Chemotherapy With Paclitaxel, Gemcitabine, and Trastuzumab in Patients With HER2 Positive Operable Breast Cancer

Primary objectives: To evaluate the pathologic complete response rate to preoperative
administration of Paclitaxel, Gemcitabine, and Trastuzumab (HerceptinÒ) (PGH) Secondary
objectives: To assess breast conserving rate after preoperative chemotherapyTo evaluate
clinical response rate, disease free survival (DFS), and overall survival (OS) To assess the
safety profiles of PGH

Treatment will be delivered in the outpatient setting. Each three-week cycle consists of
paclitaxel 80 mg/m2 (day 1, 8) and gemcitabine 1200 mg/m2 (day1, 8) in addition to
trastuzumab, which is given at a dose of 4 mg/kg IV on day 1 of the first treatment cycle
over 90 min, and subsequently given weekly at a dose of 2 mg/kg over 30 min. Patients will
receive 6 cycles of therapy unless there is any evidence of no response suitable for
operation(SD or PD) or unacceptable toxicity or noncompliance by patient with protocol
requirements. Patients who are unsuitable for op due to SD or PD, will undergo XRT. However,
when patients are still suitable for op even with SD or PD, these patients will undergo
op.Such decision will be made at physician's discretion at each institution. Also, even
though there is neither clear evidence of disease progression nor severe toxicity, if
patient declines the treatment, study treatment can be discontinued. Response will be
documented by physical examination, sonography and/or chest CT prior to treatment and every
three cycles. Postoperatively within 1-3 week, trastuzumab 6 mg/kg every 3 weeks x 11 and
tamoxifen or AI for 5 years will be given as indicated. Radiation therapy will be initiated
postoperatively in 3-4 weeks according to the standard practice guidelines.