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Completed

NCT Number: NCT01198301

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

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

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Key information

Conditions

Breast Neoplasms Breast Diseases Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Beijing Cancer Hospital

Beijing, China

About this study

  • Metastatic breast cancer tissue is obtained from core needle biopsies pretreatment and is flash frozen and stored at -70℃ until processing.
  • 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.
  • The gene expression in metastatic breast cancer tissue sample is detected by microarray to screen gene markers that are differently expressed between groups
  • Statistical analysis is performed using unsupervised hierarchical cluster.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Chemotherapy response

    Time frame: four-months

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

Secondary outcomes

  1. Time to disease progression

    Time frame: six months

    Time to disease progression is measured from the date therapy is initiated to the date of documented disease progression.

  2. Overall survival

    Time frame: one year

    Overall survival is measured from the date therapy is initiated to the date of death or final follow-up.

  3. clinical benefit response

    Time frame: six months to one year

    clinical benefit response include CR,PR,SD

Sponsors and collaborators

Lead sponsor

Peking University Cancer Hospital & Institute

Other

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Sep 10, 2010
Registry last updated
Jul 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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