NCT00532285

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: National Cancer Center, Korea · Other Government
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Paclitaxel/Gemcitabine	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).Patients will receive four cycles of therapy unless there is any evidence of no response (SD or PD) or unacceptable toxicity defined as unpredictable, irreversible, or Grade 4, or noncompliance by patient with protocol requirements.

Timeline

• Start date: 2005-09-01
• Primary completion: 2006-04-01
• Completion: 2009-08-01
• First posted: 2007-09-20
• Last updated: 2011-06-23