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

Phase 2

• Conditions: Breast Neoplasms
• Interventions: Drug: Epirubicin; Drug: Docetaxel; Drug: Trastuzumab; Drug: Carboplatin

• Registration Number: NCT02510781
• Lead Sponsor: Hospital Affiliated to Military Medical Science, Beijing

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Status Verified: 2015-07
• Study First Submitted: 2015-07-23
• Study First Submitted QC: 2015-07-27
• Last Update Submitted: 2015-07-27
• Study First Posted: 2015-07-29
• Last Update Posted: 2015-07-29
• Primary Completion: 2016-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B group	Epirubicin	Epirubicin+docetaxel+trastuzumab-docetaxel+trastuzumab
A group	Docetaxel	docetaxel+carboplatin+trastuzumab
A group	Trastuzumab	docetaxel+carboplatin+trastuzumab
B group	Docetaxel	Epirubicin+docetaxel+trastuzumab-docetaxel+trastuzumab
B group	Trastuzumab	Epirubicin+docetaxel+trastuzumab-docetaxel+trastuzumab
A group	Carboplatin	docetaxel+carboplatin+trastuzumab

Primary Outcome Measures

Name	Time	Method
pathological complete response rate	up to one year

Secondary Outcome Measures

Name	Time	Method
Number of Adverse Event	up to one year
clinical response rate	up to one year

Trial Locations

Locations (1)

Hospital affiliated to military medical science; 🇨🇳 Beijing, Beijing, China