A Study on Neoadjuvant Therapy for Her-2 Positive Breast Cancer and the Prognosis by Detecting CTCs

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

Docetaxel plus carboplatin and trastuzumab has been a standard treatment for patients with human epidermal growth factor receptor-2（HER-2）positive. The investigators witnessed a higher pathological complete remission(pCR) rate but no obvious increase in cardiac toxicity when used the anthracycline instead of carboplatin. The investigators expect to carry out a large sample size clinical research to optimize the existing therapeutic regimen

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Affiliated to Military Medical Science, Beijing
• Treatments: Carboplatin; Docetaxel; Epirubicin; Trastuzumab

Criteria

Inclusion Criteria:

• 18≤aged<70

• pathologic diagnosis of invasive breast cancer，staging ii to iii，the diameters≥2cm indicated by MRI or axillary lymph node（+）

• Immunohistochemical（IHC） positive for 3+ or FISH（+）

• clear hormone receptor（HR） status

• Eastern cooperative oncology group(ECOG)=0/1

• LVEF≥55%

• pathologic grading of Miller and Payne

• screening laboratory values with the following parameters：absolute neutrophils acount：≥1500/mm3,total bilirubin:≤2.0×ULM,Aspartate transaminase (AST)/ALT≤2.5×ULM,platelet≥80000/mm3，serum creatinine≤1.5×ULM

• no pregnant or nursing

• signed Informed consent forms

Exclusion Criteria:

• prior exposure to any treatments for breast cancer

• inflammatory/Bilateral/IV stage breast cancer

• poor physical condition

• pregnant or nursing

• Cardiac risk（Congestive heart failure、arrhythmia、myocardial infarct、Refractory hypertension（systolic pressure>180mmHg/diastolic pressure>100mmHg））

• any other cancer within 5 years prior to screening with the exception of cervical carcinoma and non melanoma skin cancer

• Allergic to chemotherapy drugs