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

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ClinicalTrials.gov Identifier: NCT02656589
Recruitment Status : Unknown
Verified October 2016 by Erwei Song, M.D., Ph.D., Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
Recruitment status was:  Recruiting
First Posted : January 15, 2016
Last Update Posted : October 13, 2016
Sponsor:
Collaborators:
Sun Yat-sen University
Huiping Li,M.D., Ph.D.,Peking University Cancer Hospital
Information provided by (Responsible Party):
Erwei Song, M.D., Ph.D., Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Brief 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

Condition or disease Intervention/treatment
Breast Cancer Drug: Capecitabine Drug: Trastuzumab

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Perspective Study of the Predictive Value of microRNA in Patients With HER2 Positive Advanced Stage Breast Cancer Who Were Treated With Herceptin
Study Start Date : June 2015
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort Intervention/treatment
Herceptin probable sensitive group
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
Capecitabine will be administered orally at a dose of 2500mg/m2 daily for 3 months (Day 1 to 14 of a 21-day cycle)
Other Name: Xeloda

Drug: Trastuzumab
patients will receive herceptin intravenous infusion at a dose of 6mg on day 1 of each cycle
Other Name: Herceptin

Herceptin probable resistant group
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
Capecitabine will be administered orally at a dose of 2500mg/m2 daily for 3 months (Day 1 to 14 of a 21-day cycle)
Other Name: Xeloda

Drug: Trastuzumab
patients will receive herceptin intravenous infusion at a dose of 6mg on day 1 of each cycle
Other Name: Herceptin




Primary Outcome Measures :
  1. 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. ]
  2. 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. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  1. The patients signed the written informed consent
  2. female patient who is ≥ 18yrs,
  3. HER2 positive: immunohistochemistry (+++) or FISH (+)
  4. stage IV
  5. the patients have no history of chemotherapy ,hormone therapy,radiotherapy or surgery after diagnosis of breast cancer
  6. the result of patients' blood tests are as follow: WBC≥3.0×109/L; Plt≥100×109/L;AST/SGOT or ALT/AGPT≤tripple of normal upper limit; Creatinine<double of the normal upper limit
  7. ECOG scores are 0 or 1 .
  8. The patient is able to take oral pills

Exclusion Criteria:

  1. The patient was never exposed to herceptin.
  2. The patient suffered from other non-breast malignancy in the last 5 years, except for cervical carcinoma in situ, radical basal cell carcinoma or squamous cell carcinoma.
  3. The life expectancy is less than 3 months.
  4. Severe hepatic function disorder, Child Pugh grade C.
  5. Severe cardiac function disorder, cardiac function is more than grade III;
  6. Prolonged QT interval;
  7. Arrhythmia or taking anti-arrhythmia drugs;
  8. Pregnant or breast feeding female.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02656589


Contacts
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Contact: Erwei Song, Ph.D 86-20-81332576 songerwei02@yahoo.com.cn
Contact: Shicheng Su, Ph.D +8613631304227 seasonso@163.com

Locations
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China, Guangdong
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Recruiting
Guangzhou, Guangdong, China, 510120
Contact: Erwei Song, M.D.,Ph.D.       songerwei02@yahoo.com.cn   
Contact: Qiang Liu       victorlq@hotmail.com.com   
Principal Investigator: Erwei Song, M.D.,Ph.D.         
Sponsors and Collaborators
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sun Yat-sen University
Huiping Li,M.D., Ph.D.,Peking University Cancer Hospital
Investigators
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Study Chair: Erwei Song, Ph.D Sun Yat-Sen Memerial Hospital of Sun Yat-Sen University

Publications of Results:

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Responsible Party: Erwei Song, M.D., Ph.D., President of Sun Yat-Sen Memorial Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT02656589     History of Changes
Other Study ID Numbers: SSC201512
First Posted: January 15, 2016    Key Record Dates
Last Update Posted: October 13, 2016
Last Verified: October 2016

Keywords provided by Erwei Song, M.D., Ph.D., Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University:
breast cancer
herceptin
microRNA

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Capecitabine
Trastuzumab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Immunological