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

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ClinicalTrials.gov Identifier: NCT02510781
Recruitment Status : Unknown
Verified July 2015 by Hospital Affiliated to Military Medical Science, Beijing.
Recruitment status was:  Recruiting
First Posted : July 29, 2015
Last Update Posted : July 29, 2015
Sponsor:
Information provided by (Responsible Party):
Hospital Affiliated to Military Medical Science, Beijing

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

Condition or disease Intervention/treatment Phase
Breast Neoplasms Drug: Epirubicin Drug: Docetaxel Drug: Trastuzumab Drug: Carboplatin Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study on Neoadjuvant Therapy for Her-2 Positive Breast Cancer and the Prognosis Detecting Circulating Tumor Cells
Study Start Date : January 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: A group
docetaxel+carboplatin+trastuzumab
Drug: Docetaxel
75mg/m2 d1 evry 21days
Other Name: Taxotere

Drug: Trastuzumab
6mg/kg(loading dosage is 8mg/kg)
Other Name: Herceptin

Drug: Carboplatin
Area Under Curve(AUC)=6 d1 evry 21days
Other Name: Paraplatin

Active Comparator: B group
Epirubicin+docetaxel+trastuzumab-docetaxel+trastuzumab
Drug: Epirubicin
75mg/m2 d1 evry 21days
Other Name: pharmorubicin

Drug: Docetaxel
75mg/m2 d1 evry 21days
Other Name: Taxotere

Drug: Trastuzumab
6mg/kg(loading dosage is 8mg/kg)
Other Name: Herceptin




Primary Outcome Measures :
  1. pathological complete response rate [ Time Frame: up to one year ]

Secondary Outcome Measures :
  1. clinical response rate [ Time Frame: up to one year ]
  2. Number of Adverse Event [ Time Frame: up to one year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02510781


Contacts
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Contact: tao wang, Ph.D 8610-66947172 wangtao733073@163.com
Contact: zefei jiang, Ph.D 8610-66947171 jiangzf@hotmail.com

Locations
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China, Beijing
Hospital affiliated to military medical science Recruiting
Beijing, Beijing, China, 100000
Contact: tao wang, Ph.D    8610-66947172    wangtao733073@163.com   
Contact: zefei jiang, ph.d    8610-66947171    zfjiang@hotmail.com   
Sponsors and Collaborators
Hospital Affiliated to Military Medical Science, Beijing
Investigators
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Principal Investigator: zefei jiang, Ph.D Academy MMS,China

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Responsible Party: Hospital Affiliated to Military Medical Science, Beijing
ClinicalTrials.gov Identifier: NCT02510781     History of Changes
Other Study ID Numbers: BJ307-Neo02
First Posted: July 29, 2015    Key Record Dates
Last Update Posted: July 29, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carboplatin
Docetaxel
Trastuzumab
Epirubicin
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors