A Study on Neoadjuvant Therapy for Her-2 Positive Breast Cancer and the Prognosis by Detecting CTCs
NCT ID: NCT02510781
Last Updated: 2015-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
200 participants
INTERVENTIONAL
2015-01-31
2017-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
TCH Versus EC-TH as Neoadjuvant Treatment for HER2-Positive Breast Cancer
NCT03140553
Neoadjuvant Therapy Study Guided by Drug Screening in Vitro for HER2 Positive Early Breast Cancer Patients
NCT04750122
Efficacy and Safety Study of Trastuzumab and Paclitaxel Based Regimens to Treat HER2-positive Breast Cancer
NCT01428414
Four Cycles Taxane With Trastuzumab and Pertuzumab Neoadjuvant Therapy Among Low Risk HER2 Positive Patients
NCT06722599
Efficacy of TQB2102 Versus TCbHP in Neoadjuvant Therapy for HER2-positive Early Breast Cancer.
NCT07136974
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
A group
docetaxel+carboplatin+trastuzumab
Docetaxel
75mg/m2 d1 evry 21days
Trastuzumab
6mg/kg(loading dosage is 8mg/kg)
Carboplatin
Area Under Curve(AUC)=6 d1 evry 21days
B group
Epirubicin+docetaxel+trastuzumab-docetaxel+trastuzumab
Epirubicin
75mg/m2 d1 evry 21days
Docetaxel
75mg/m2 d1 evry 21days
Trastuzumab
6mg/kg(loading dosage is 8mg/kg)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
69 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospital Affiliated to Military Medical Science, Beijing
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
zefei jiang, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Academy MMS,China
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital affiliated to military medical science
Beijing, Beijing Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BJ307-Neo02
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.