SNPMiner Trials (Home Page)
Report for Clinical Trial NCT00542451
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
The purpose of this study is to find out what effect the postoperative combination of
therapies: trastuzumab (herceptin) and paclitaxel (taxol) will have on breast cancer
recurrence. A combination of trastuzuamb and chemotherapy has been used in women with node
positive and high risk node negative disease. This tests utilizes a well tolerated regimen of
weekly paclitaxel and trastuzumab in women with T1, node negative tumors that are HER2
positive. We would like to determine how effective this drug combination is when used in
women with early stage breast cancer, as well as to better define the side effects of this
treatment.
Name: Paclitaxel
Description: Every week for 12 weeks
Type: Drug
Name: Trastuzumab
Description: Once a week for twelve weeks Then once a week or once every three weeks for 40 weeks
Type: Drug
Primary Outcomes
Measure: Evaluate disease free survival (DFS) rate in patients with node-negative HER2-positive breast cancer with tumors less than or equal to 3cm treated with adjuvant trastuzumab and paclitaxel Time: 3 years
Secondary Outcomes
Measure: Describe DFS in patient groups defined by tumor size and hormone receptor status. Time: 3 years
Measure: Evaluate the incidence of grade III/IV cardiac left ventricular dysfunction from adjuvant trastuzumab and paclitaxel Time: 3 years
Measure: Evaluate the incidence of grade III/IV neurotoxicity associated with adjuvant paclitaxel Time: 3 years
Measure: Evaluate Topoisomerase II, cMYC, and p53 expression, and correlate with event rate Time: 3 years
Measure: Evaluate P13K mutations and PTEN alterations in a subset of patients and correlate events with the presence or absence of these mutations/alterations Time: 3 Years
Purpose: Treatment
Allocation: Non-Randomized
Single Group Assignment
There is one SNP
SNPs
1 P13K
Evaluate P13K mutations and PTEN alterations in a subset of patients and correlate events with the presence or absence of these mutations/alterations. --- P13K ---