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

This study is currently recruiting participants.
Verified August 2010 by Beijing Cancer Hospital
Sponsor:
Information provided by:
Beijing Cancer Hospital
ClinicalTrials.gov Identifier:
NCT01198301
First received: September 9, 2010
Last updated: July 21, 2011
Last verified: August 2010
History of Changes
  Purpose

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


Condition
Breast Neoplasms
Neoplasm Metastasis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Gene Expression Profiling of Metastatic Breast Cancer Predict the Therapeutic Response to Chemotherapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Beijing Cancer Hospital:

Primary Outcome Measures:
  • Chemotherapy response [ Time Frame: four-months ] [ Designated as safety issue: Yes ]
    Response to chemotherapy is assessed using Response Evaluation Criteria in Solid Tumor Group (RECIST) guidelines


Secondary Outcome Measures:
  • Time to disease progression [ Time Frame: six months ] [ Designated as safety issue: Yes ]
    Time to disease progression is measured from the date therapy is initiated to the date of documented disease progression.

  • Overall survival [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    Overall survival is measured from the date therapy is initiated to the date of death or final follow-up.

  • clinical benefit response [ Time Frame: six months to one year ] [ Designated as safety issue: Yes ]
    clinical benefit response include CR,PR,SD


Biospecimen Retention:   Samples Without DNA

the tissue will be obtained by core niddle biopsy.


Estimated Enrollment: 30
Study Start Date: August 2010
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

female patients with metastatic breast cancer treated by Docetaxel-based chemotherapy

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01198301

Contacts
Contact: Jun Ren, MD +86-10-88196356 renjun9688@yahoo.com
Contact: Zheng Wang, PhD +86-10-88196328 azhengsmile@yahoo.com.cn

Locations
China
Beijing Cancer Hospital Recruiting
Beijing, China
Contact: Jun Ren, MD     +86-10-88196356     renjun9688@yahoo.com    
Sponsors and Collaborators
Beijing Cancer Hospital
Investigators
Principal Investigator: Zheng Wang, PhD Beijing Cancer Hospital
Study Chair: Jun Ren, MD Beijing Cancer Hospital
  More Information

No publications provided

Responsible Party: Jun Ren/Director of the Medical Oncology Department, Beijing Cancer Hospital
ClinicalTrials.gov Identifier: NCT01198301     History of Changes
Other Study ID Numbers: GEP
Study First Received: September 9, 2010
Last Updated: July 21, 2011
Health Authority: China: Ministry of Health

Keywords provided by Beijing Cancer Hospital:
Metastatic Breast Neoplasms
Gene Expression Profiling
Drug Therapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasm Metastasis
Neoplasms by Site
 Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013