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


N/A
18 Years
75 Years
Open (Enrolling)
Female
Breast Neoplasms, Neoplasm Metastasis

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Trial Information

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


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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Chemotherapy response

Outcome Description:

Response to chemotherapy is assessed using Response Evaluation Criteria in Solid Tumor Group (RECIST) guidelines

Outcome Time Frame:

four-months

Safety Issue:

Yes

Principal Investigator

Zheng Wang, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beijing Cancer Hospital

Authority:

China: Ministry of Health

Study ID:

GEP

NCT ID:

NCT01198301

Start Date:

August 2010

Completion Date:

July 2013

Related Keywords:

  • Breast Neoplasms
  • Neoplasm Metastasis
  • Metastatic Breast Neoplasms
  • Gene Expression Profiling
  • Drug Therapy
  • Breast Neoplasms
  • Neoplasms
  • Neoplasm Metastasis

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