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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01198301 |
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Date of registration:
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09/09/2010 |
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Primary sponsor: |
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Public title:
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Gene Expression Profiling of Metastatic Breast Cancer Predict the Therapeutic Response to Chemotherapy
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Scientific title:
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Gene Expression Profiling of Metastatic Breast Cancer Predict the Therapeutic Response to Chemotherapy |
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Date of first enrolment:
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August 2010 |
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Target sample size:
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30 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01198301 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Countries of recruitment
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China
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Contacts
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Name:
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Jun Ren, MD |
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Address:
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Telephone:
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+86-10-88196356 |
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Email:
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renjun9688@yahoo.com |
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Affiliation:
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Name:
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Jun Ren, MD |
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Address:
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Telephone:
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+86-10-88196356 |
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Email:
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renjun9688@yahoo.com |
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Affiliation:
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Name:
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Jun Ren, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Beijing Cancer Hospital |
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Name:
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Zheng Wang, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Beijing Cancer Hospital |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast Neoplasms
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Neoplasm Metastasis
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Primary Outcome(s)
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Chemotherapy response
[Time Frame: four-months]
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Secondary Outcome(s)
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clinical benefit response
[Time Frame: six months to one year]
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Overall survival
[Time Frame: one year]
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Time to disease progression
[Time Frame: six months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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