SNPMiner Trials by Shray Alag


SNPMiner SNPMiner Trials (Home Page)


Report for Clinical Trial NCT00542451

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase II Trial of Adjuvant Paclitaxel and Trastuzumab for Node-Negative HER2-Positive Breast Cancer

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.

NCT00542451 Breast Cancer Carcinoma of the Breast
MeSH:Breast Neoplasms
HPO:Breast carcinoma Neoplasm of the breast

2 Interventions

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 ---



HPO Nodes


HPO: