Primary Paclitaxel Plus Gemcitabine in Patients With Stage II and III Breast Cancer
Primary Paclitaxel Plus Gemcitabine in Patients With Stage II and III Breast Cancer
This is an open labeled phase II single arm trial. The patients with clinical stage II and
 III will undergo core-needle biopsy of breast tumor for histologic diagnosis,
 immunohistochemical studies for estrogen receptor (ER), progesterone receptor(PR), HER-2/neu
 and others. PET or ultrasound results will determine the positivity of lymph node metastasis.
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.
Inclusion Criteria:

 -  All patients must have histologically confirmed and newly diagnosed breast cancer:
 node-positive stage IIA and any stage IIB, III. PET results will determine node
 positivity. If PET was not utilized, sonographically positive node should be confirmed
 cytologically by fine needle aspiration.

 -  No prior hormonal, chemotherapy or radiotherapy is allowed.

 -  No breast operation other than biopsy to make diagnosis is allowed.

 -  Age: 18-years and older, not pregnant pre-, and postmenopausal women with good
 performance status (ECOG 0-1)

 -  Adequate hematopoietic function: Absolute granulocyte count ³1500/mm3, platelet
 ³100,000/mm3, Hemoglobin ³ 10 g/mm3

 -  Adequate renal function: Serum creatinine £ 1.5 mg/dl

 -  Adequate hepatic function: total bilirubin: £ 1.5 mg/dl, AST/ALT: £ two times normal,
 Alkaline phosphatase: £ two times normal

 -  Adequate cardiac function: normal or nonspecific EKG taken within 1 mo of enrollment

 -  Adequate mental function to understand and sign the consent

 Exclusion Criteria:

 -  Patients who received hormonal, chemotherapy or radiotherapy for breast cancer

 -  Patients who underwent surgery for breast cancer

 -  Patients with node-negative stage IIA breast cancer

 -  Patients who have history of cancer other than in situ uterine cervix cancer or
 nonmelanotic skin cancer