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

Primary Purpose

Breast Neoplasms

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Epirubicin
Docetaxel
Trastuzumab
Carboplatin
Sponsored by
Hospital Affiliated to Military Medical Science, Beijing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Neoplasms

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Hospital affiliated to military medical scienceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A group

B group

Arm Description

docetaxel+carboplatin+trastuzumab

Epirubicin+docetaxel+trastuzumab-docetaxel+trastuzumab

Outcomes

Primary Outcome Measures

pathological complete response rate

Secondary Outcome Measures

clinical response rate
Number of Adverse Event

Full Information

First Posted
July 23, 2015
Last Updated
July 27, 2015
Sponsor
Hospital Affiliated to Military Medical Science, Beijing
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1. Study Identification

Unique Protocol Identification Number
NCT02510781
Brief Title
A Study on Neoadjuvant Therapy for Her-2 Positive Breast Cancer and the Prognosis by Detecting CTCs
Official Title
A Study on Neoadjuvant Therapy for Her-2 Positive Breast Cancer and the Prognosis Detecting Circulating Tumor Cells
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Affiliated to Military Medical Science, Beijing

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A group
Arm Type
Experimental
Arm Description
docetaxel+carboplatin+trastuzumab
Arm Title
B group
Arm Type
Active Comparator
Arm Description
Epirubicin+docetaxel+trastuzumab-docetaxel+trastuzumab
Intervention Type
Drug
Intervention Name(s)
Epirubicin
Other Intervention Name(s)
pharmorubicin
Intervention Description
75mg/m2 d1 evry 21days
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Taxotere
Intervention Description
75mg/m2 d1 evry 21days
Intervention Type
Drug
Intervention Name(s)
Trastuzumab
Other Intervention Name(s)
Herceptin
Intervention Description
6mg/kg(loading dosage is 8mg/kg)
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Paraplatin
Intervention Description
Area Under Curve(AUC)=6 d1 evry 21days
Primary Outcome Measure Information:
Title
pathological complete response rate
Time Frame
up to one year
Secondary Outcome Measure Information:
Title
clinical response rate
Time Frame
up to one year
Title
Number of Adverse Event
Time Frame
up to one year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
tao wang, Ph.D
Phone
8610-66947172
Email
wangtao733073@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
zefei jiang, Ph.D
Phone
8610-66947171
Email
jiangzf@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
zefei jiang, Ph.D
Organizational Affiliation
Academy MMS,China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital affiliated to military medical science
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
tao wang, Ph.D
Phone
8610-66947172
Email
wangtao733073@163.com
First Name & Middle Initial & Last Name & Degree
zefei jiang, ph.d
Phone
8610-66947171
Email
zfjiang@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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