Overview

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