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

Sun Yat-sen University

Status: Unknown

Conditions: Breast Cancer

Treatments: Drug: Capecitabine; Drug: Trastuzumab

Study type: Observational

Funder types: Other

Identifiers

NCT02656589

SSC201512

Details and patient eligibility

About

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

Enrollment: 300 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

300 participants in 2 patient groups

Herceptin probable sensitive group

Description:

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

Treatment:

Drug: Trastuzumab

Drug: Capecitabine

Herceptin probable resistant group

Description:

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

Treatment:

Drug: Trastuzumab

Drug: Capecitabine