Gene Expression Profiling of Metastatic Breast Cancer Predict the Therapeutic Response to Chemotherapy

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01198301

Enrollment

Registered

2010-09-10

Start date

2010-08-31

Completion date

2012-07-31

Last updated

2015-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms, Neoplasm Metastasis

Keywords

Metastatic Breast Neoplasms, Gene Expression Profiling, Drug Therapy

Brief summary

The investigators want to develop a gene expression profile the for prediction the chemotherapeutic response of patients with metastatic breast cancer.

Detailed description

1. Metastatic breast cancer tissue is obtained from core needle biopsies pretreatment and is flash frozen and stored at -70℃ until processing. 2. After patients received docetaxel combination thiotepa for two cycles, response is assessed using Response Evaluation Criteria in Solid Tumor Group (RECIST) guidelines. Degree of response is used to divide the cancers into two groups-sensitive and resistant tumours. 3. The gene expression in metastatic breast cancer tissue sample is detected by microarray to screen gene markers that are differently expressed between groups 4. Statistical analysis is performed using unsupervised hierarchical cluster.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Patients should be histologically confirmed with metastatic breast cancer; * Patients who had completed the planned chemotherapy regimen with no major protocol violation; * an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; * At least one measurable lesion; * Normal cardiac, hepatic, renal and bone marrow functions; * Life expectancy ≥3 months; * Discontinuity of previous chemotherapy for a minimum of 4 weeks.

Exclusion criteria

* previous history of other malignancies; * previous surgery history on the needle biopsy organ; * Central nervous system metastases; * Serious or uncontrolled concurrent medical illness.

Design outcomes

Primary

Measure	Time frame	Description
Chemotherapy response	four-months	Response to chemotherapy is assessed using Response Evaluation Criteria in Solid Tumor Group (RECIST) guidelines

Secondary

Measure	Time frame	Description
Time to disease progression	six months	Time to disease progression is measured from the date therapy is initiated to the date of documented disease progression.
Overall survival	one year	Overall survival is measured from the date therapy is initiated to the date of death or final follow-up.
clinical benefit response	six months to one year	clinical benefit response include CR,PR,SD

Countries

China

Outcome results