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

Breast Neoplasms Clinical Trial

Official title:

A Study on Neoadjuvant Therapy for Her-2 Positive Breast Cancer and the Prognosis Detecting Circulating Tumor Cells

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02510781
• Other study ID #: BJ307-Neo02
• Status: Recruiting
• Phase: Phase 2
• First received: July 23, 2015
• Last updated: July 27, 2015
• Start date: January 2015
• Est. completion date: December 2017

Study information

• Verified date: July 2015
• Source: Hospital Affiliated to Military Medical Science, Beijing
• Contact: tao wang, Ph.D
• Phone: 8610-66947172
• Email: wangtao733073[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 69 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• Epirubicin
75mg/m2 d1 evry 21days
• Docetaxel
75mg/m2 d1 evry 21days
• Trastuzumab
6mg/kg(loading dosage is 8mg/kg)
• Carboplatin
Area Under Curve(AUC)=6 d1 evry 21days

Locations

Country	Name	City	State
China	Hospital affiliated to military medical science	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Affiliated to Military Medical Science, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pathological complete response rate		up to one year	No
Secondary	clinical response rate		up to one year	No
Secondary	Number of Adverse Event		up to one year	No