A Study on Neoadjuvant Therapy for Her-2 Positive Breast Cancer and the Prognosis by Detecting CTCs
1 other identifier
interventional
200
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2015
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 23, 2015
CompletedFirst Posted
Study publicly available on registry
July 29, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedJuly 29, 2015
July 1, 2015
1.9 years
July 23, 2015
July 27, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
pathological complete response rate
up to one year
Secondary Outcomes (2)
clinical response rate
up to one year
Number of Adverse Event
up to one year
Study Arms (2)
A group
EXPERIMENTALdocetaxel+carboplatin+trastuzumab
B group
ACTIVE COMPARATOREpirubicin+docetaxel+trastuzumab-docetaxel+trastuzumab
Interventions
Eligibility Criteria
You may qualify if:
- ≤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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital affiliated to military medical science
Beijing, Beijing Municipality, 100000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
zefei jiang, Ph.D
Academy MMS,China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2015
First Posted
July 29, 2015
Study Start
January 1, 2015
Primary Completion
December 1, 2016
Study Completion
December 1, 2017
Last Updated
July 29, 2015
Record last verified: 2015-07