Breast Cancer
Conditions
Keywords
breast cancer, herceptin, microRNA
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
Interventions
DRUGCapecitabine
Capecitabine will be administered orally at a dose of 2500mg/m2 daily for 3 months (Day 1 to 14 of a 21-day cycle)
DRUGTrastuzumab
patients will receive herceptin intravenous infusion at a dose of 6mg on day 1 of each cycle
Sponsors
Sun Yat-sen University
Huiping Li,M.D., Ph.D.,Peking University Cancer Hospital
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progress-free survival of patients | 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 | 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. |
Countries
China
Contacts
Primary ContactErwei Song, Ph.D
Backup ContactShicheng Su, Ph.D
Outcome results
None listed