Primary Paclitaxel Plus Gemcitabine in Patients With Stage II and III Breast Cancer

• Status: Terminated
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Center, Korea
• Treatments: Albumin-Bound Paclitaxel; Gemcitabine; Paclitaxel

Criteria

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