Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00352378
Status:
COMPLETED
Last Update Posted:
2011-06-27
First Post:
2006-07-13
Brief Title:
Primary Chemotherapy With AdriamycinCyclophosphamideAC vs TaxotereXelodaTX for Stage II and III Breast Cancer
Sponsor:
National Cancer Center Korea
Organization:
National Cancer Center Korea
Study Overview
Official Title:
A Phase III Randomized Study of Primary Chemotherapy With AdriamycinCyclophosphamideAC vs TaxotereXelodaTX for Stage II and III Breast Cancer
Status:
COMPLETED
Status Verified Date:
2007-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open labeled phase III randomized trial The patients with clinical stage II and III will undergo mammotome biopsy of breast tumor for histologic diagnosis immunohistochemical studies for estrogen receptorER progesterone receptorPR HER-2neu and others PET results will determine the positivity of lymph node metastasis
Detailed Description:
- Patients will be randomized to receive regimen A AC and regimen BTX preoperativelyas follows Regimen A AC Intravenous infusion of Adriamycin 60mgm2 over 30 min onD1 and Intravenous infusion of cyclophosphamide 600 mgm2 over 30 min on D1 Regimen BTX Intravenous infusion of Taxotere 75 mgm2 over 1 hr on D1 and Xeloda 1000mgm2po BID x 14days on D1-D14 The cycle repeats every 3 weeks for 4 times Premedication for regimen A includes antiemetics for regimen B dexamethasone as routinely given
Patients who do not respond to the initial two cycles of preoperative chemotherapy will undergo operation
The response rate will be determined by the number of patients with complete and partial responses according to RECIST guidelines Pathologic complete response is defined as no pathologic evidence of residual disease Safety will be evaluated by the frequency severity and relationship of adverse events graded by NCI Common Toxicity CriteriaCTC that occur during the treatment and follow-up periods Time to disease progression will be calculated from the date of study entry to the first objective documentation of progressive disease Response duration will be measured from the date a patient first fulfills the CR or PR criteria to the first date of objective documentation of disease progression Survival time will be calculated from the date of study entry to the date of death
Patients who do not respond to the initial two cycles of preoperative chemotherapy will undergo operation
The response rate will be determined by the number of patients with complete and partial responses according to RECIST guidelines Pathologic complete response is defined as no pathologic evidence of residual disease Safety will be evaluated by the frequency severity and relationship of adverse events graded by NCI Common Toxicity CriteriaCTC that occur during the treatment and follow-up periods Time to disease progression will be calculated from the date of study entry to the first objective documentation of progressive disease Response duration will be measured from the date a patient first fulfills the CR or PR criteria to the first date of objective documentation of disease progression Survival time will be calculated from the date of study entry to the date of death
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None