Primary Paclitaxel Plus Gemcitabine in Patients With Stage II and III Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00532285|
Recruitment Status : Terminated (terminated)
First Posted : September 20, 2007
Last Update Posted : June 23, 2011
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Paclitaxel/Gemcitabine||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Primary Paclitaxel Plus Gemcitabine in Patients With Stage II and III Breast Cancer|
|Study Start Date :||September 2005|
|Actual Primary Completion Date :||April 2006|
|Actual Study Completion Date :||August 2009|
paclitaxel 80 mg/m2 (day 1, 8) and gemcitabine 1200 mg/m2 (day1, 8) every 3 weeks, 4 cycles
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.
- To evaluate the clinical and pathologic responses to preoperative administration of Paclitaxel/Gemcitabine (PG) [ Time Frame: two years ]
- To assess breast conserving rate To evaluate the disease free survival (DFS) and overall survival (OS) of patients who received preoperatively PG To investigate the toxicity profiles of PG [ Time Frame: two years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00532285
|Principal Investigator:||Jungsil Ro, MD, PhD||National Cancer Center|