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

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University300 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Breast Cancer

Interventions

CapecitabineDRUG

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Central Contacts

Erwei Song, Ph.D

CONTACT

86-20-81332576 songerwei02@yahoo.com.cn

Shicheng Su, Ph.D