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

Hospital Affiliated to Military Medical Science, Beijing

Status and phase: Unknown; Phase 2

Conditions: Breast Neoplasms

Treatments: Drug: Carboplatin; Drug: Trastuzumab; Drug: Docetaxel; Drug: Epirubicin

Study type: Interventional

Funder types: Other

Identifiers

NCT02510781

BJ307-Neo02

Details and patient eligibility

About

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

Enrollment: 200 estimated patients

Sex: Female

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

A group

Experimental group

Description:

docetaxel+carboplatin+trastuzumab

Treatment:

Drug: Docetaxel

Drug: Trastuzumab

Drug: Carboplatin

B group

Active Comparator group

Description:

Epirubicin+docetaxel+trastuzumab-docetaxel+trastuzumab

Treatment:

Drug: Docetaxel

Drug: Epirubicin

Drug: Trastuzumab