An observational study in Breast Cancer, sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. Status unknown at 1 site in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-10-13.
Sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Observational
This projective observational study is planned to enroll more than 300 advanced breast cancer patients, who were proved as Her-2 positive using fluorescence in situ hybridization (FISH) and / or immunohistochemistry, and 100 healthy donors as control. Before treatment, the plasma microRNA will be collected and detected by microRNA extraction kit and quantitative polymerase chain reaction (qPCR), respectively. After analyzed their microRNA expression by microRNA predictive model, previously reported by our team, all of enrolled patients will be classified as "probable sensitive group" or "probable resistant group". Herceptin combined with other chemotherapy will be the backbone of salvage treatment and used for at least 3 months; the change of local masses and metastasis lesions after treatment will be documented to evaluate the response. Based on these results, investigator aim to construct a mathematical predictive model by analyzing the correlation of baseline microRNA expression level and the prognosis of patients. And a diagnosis microRNA kit will be planned and manufactured
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 300 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University is the lead sponsor of 466 studies on the registry; 271 are open to participants now.
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advanced breast cancer patients first diagnosis in Sun Yat-sen Memorial Hospital, Sun Yat-sen University. Informed consent must be obtained for all of the included patients.
Exclusion Criteria:
Plasma microRNAs will be collected using microRNA extraction kit according to manufacturer's instructions; and their expression levels are analyzed by quantitative polymerase chain reaction (qPCR).According to microRNAs - herceptin predictive model(reported by our team), the patients will be considered as Herceptin probable sensitive group
Drug: Capecitabine · Drug: Trastuzumab
Plasma microRNAs will be collected using microRNA extraction kit according to manufacturer's instructions; and their expression levels are analyzed by quantitative polymerase chain reaction (qPCR).According to microRNAs - herceptin predictive model(reported by our team), the patients will be considered as Herceptin probable resistant group
Drug: Capecitabine · Drug: Trastuzumab
Capecitabine will be administered orally at a dose of 2500mg/m2 daily for 3 months (Day 1 to 14 of a 21-day cycle)
Also known as: Xeloda
patients will receive herceptin intravenous infusion at a dose of 6mg on day 1 of each cycle
Also known as: Herceptin
Progress-free survival of patients
Time frame: progression free survival (PFS) was defined as the interval from the diagnosis of advanced breast cancer with HER2 positive to disease progression, relapse, death due to any causes or last follow-up.The follow-up interval is 2 years.
overall survival of patients
Time frame: Overall survival was defined as the interval from the diagnosis of advanced breast cancer with HER2 positive to death due to any causes or last follow-up,The follow-up interval is 2 years.
This study is status unknown, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University