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microRNA of Human Epidermal Growth Factor Receptor 2 （HER2）Positive Patient Treated With Herceptin

NCT02656589 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2016-10-13

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

Capecitabine

Capecitabine will be administered orally at a dose of 2500mg/m2 daily for 3 months (Day 1 to 14 of a 21-day cycle)

DRUG

Trastuzumab

patients will receive herceptin intravenous infusion at a dose of 6mg on day 1 of each cycle

Sponsors & Collaborators

  • Sun Yat-sen University

    collaborator OTHER

  • Huiping Li,M.D., Ph.D.,Peking University Cancer Hospital

    collaborator UNKNOWN

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    lead OTHER

Principal Investigators

  • Erwei Song, Ph.D · Sun Yat-Sen Memerial Hospital of Sun Yat-Sen University

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2018-06-30
Completion
2018-06-30

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02656589 on ClinicalTrials.gov