SNPMiner Trials by Shray Alag

SNPMiner SNPMiner Trials (Home Page)

Report for Clinical Trial NCT00079326

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase 2 Study of Trastuzumab in Combination With BMS-247550 in Women With Metastatic Breast Cancer

This phase II trial is studying how well giving trastuzumab together with ixabepilone works in treating women with HER2-positive metastatic breast cancer. Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining trastuzumab with ixabepilone may kill more tumor cells.

NCT00079326 HER2-positive Breast Cancer Recurrent Breast Cancer Stage IV Breast Cancer
MeSH:Breast Neoplasms
HPO:Breast carcinoma Neoplasm of the breast

3 Interventions

Name: trastuzumab

Description: Given IV
Type: Biological
Group Labels: 1

Treatment (trastuzumab, ixabepilone)

Name: ixabepilone

Description: Given IV
Type: Drug
Group Labels: 1

Treatment (trastuzumab, ixabepilone)

Name: laboratory biomarker analysis

Description: Correlative studies
Type: Other
Group Labels: 1

Treatment (trastuzumab, ixabepilone)

Primary Outcomes

Description: Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by computed tomography or magnetic resonance imaging scans: Complete response (CR) is defined as the disappearance of all target lesions; Partial Response is defined by at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response Rate (ORR) = CR + PR.

Measure: Overall Response Rate

Time: Up to 6 years

Secondary Outcomes

Description: Time to Treatment Failure as determined by RECIST v.1.0 Criteria: is the time from the date of randomization or start of treatment to the earliest date of progression, date of death due to any cause, or date of discontinuation due to reasons of adverse events, abnormal laboratory values, abnormal test procedure results, subject withdraws consent, or date 'Lost to follow up'.

Measure: Time to Treatment Failure (TTF)

Time: up to 6 years

Purpose: Treatment

Allocation: N/A

Single Group Assignment

There is one SNP


1 P13K

HER2/phospho-HER2, EGFR/phospho-EGFR, IGRF-I, phospho-MAPK, phospho-P13K, bcl-2, bcl-xL, MDR-1, MRP and β-tubulin) and blood biomarkers (HER2-extracellular domain [ECD], circulating tumor cells) to correlate them with response to treatment. --- P13K ---

HPO Nodes