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Nimotuzumab Plus Docetaxel and Capecitabine Versus Docetaxel and Capecitabine in the Treatment of Breast Cancer Patients

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ClinicalTrials.gov Identifier: NCT01939054
Recruitment Status : Unknown
Verified June 2015 by Binghe Xu, Chinese Academy of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : September 11, 2013
Last Update Posted : June 4, 2015
Sponsor:
Collaborator:
Biotech Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Binghe Xu, Chinese Academy of Medical Sciences

Tracking Information
First Submitted Date  ICMJE August 28, 2013
First Posted Date  ICMJE September 11, 2013
Last Update Posted Date June 4, 2015
Study Start Date  ICMJE September 2013
Estimated Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2013)
ORR [ Time Frame: every six weeks, up to 1 year ]
Evaluation ORR every six weeks,with RECIST 1.1.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01939054 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2013)
  • PFS [ Time Frame: every six weeks, up to 1 year ]
  • Number and ratio of AEs [ Time Frame: up to 1 year ]
    Observe and record AEs when AEs occurred
  • Relationship of tissue/serum EGFR between efficacy and prognosis [ Time Frame: 1 year ]
    every 6 weeks
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nimotuzumab Plus Docetaxel and Capecitabine Versus Docetaxel and Capecitabine in the Treatment of Breast Cancer Patients
Official Title  ICMJE A Randomized, Controlled, Open-Label, Multicenter, Phase 2 Study of Nimotuzumab Plus Docetaxel and Capecitabine Versus Docetaxel and Capecitabine as First-Line Treatment in Patients With Recurrent/Metastatic Triple Negative Breast Cancer
Brief Summary Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR), inhibiting tyrosine kinase activation. This is a randomized, controlled, open-Label, multicenter, phase Ⅱ clinical trial of nimotuzumab plus Docetaxel and Capecitabine(TX)versus Docetaxel and Capecitabine(TX)as first-line treatment in patients with recurrent/metastatic triple negative breast cancer.
Detailed Description The control group received docetaxel + capecitabine regimen;Experimental group received Nimotuzumab combined docetaxel + capecitabine regimen.The main purpose is to evaluate Nimotuzumab Plus Docetaxel and Capecitabine(TX)as First-Line Treatment in Patients With Recurrent/Metastatic triple negative breast cancer would improve objective response rate (ORR ) comparing with Docetaxel and Capecitabine(TX).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: Nimotuzumab
  • Drug: docetaxel
  • Drug: capecitabine
Study Arms  ICMJE
  • Experimental: Nimotuzumab,docetaxel,capecitabine
    Nimotuzumab 400mg/w,IV,once a week and Docetaxel 75 mg/m2,IV,D1, every 21 days a cycle and Capecitabine 1000mg/m2, orally, twice daily, D1-D14
    Interventions:
    • Drug: Nimotuzumab
    • Drug: docetaxel
    • Drug: capecitabine
  • Active Comparator: docetaxel,capecitabine
    Docetaxel 75 mg/m2,IV,D1, every 21 days a cycle and Capecitabine 1000mg/m2, orally, twice daily, D1-D14
    Interventions:
    • Drug: docetaxel
    • Drug: capecitabine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 5, 2013)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2016
Estimated Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Histological and immunohistochemistry (IHC) confirmed recurrent or metastatic triple-negative breast cancer .
  2. Previous chemotherapy should include anthracycline or taxane; No prior chemotherapy after metastasis.
  3. Females with age between 18 and 70 years old
  4. ECOG performance status 0 or 1.
  5. At least one measurable disease according to the response evaluation criteria in solid tumor (RECIST) by magnetic resonance imaging, or computed tomography; The target lesions is Unresectable; The target lesions did not receive radiotherapy or relapse within the radiation field;
  6. Life expectancy ≥ 12 weeks.;
  7. WBC count ≥ 4 × 109 / L, neutrophils ≥ 1.5 × 109 / L, platelet count ≥ 100 × 109 / L, hemoglobin ≥ 6.21mmol / L (10 g / dL);
  8. Total bilirubin (TBL)≤ 1.5 x ULN (upper limit of normal reference values); AST and ALT ≤ 2.5 x ULN or ≤ 5 ULN (Liver metastasis);Serum creatinine ≤ 1.5 x ULN.
  9. Before enrollment, patients have fully recovered from previous treatment-related toxicity;
  10. Subjects with fertility must accept effective contraceptive measures;
  11. Signed informed consent

Exclusion Criteria:

  1. Previously treatment regimen including anti EGFR monoclonal antibody;
  2. Receiving other anti-cancer medicine treatment during the study
  3. Participate in other clinical trials within 4 weeks in this group;
  4. Accepted taxane treatment in 1 year;
  5. Presence of neurological symptoms due to brain metastasis, patients receiving steroidal anti-edema drugs therapy;
  6. Patients having a history of clinically significant symptomatic angina, arrhythmia or congestive heart failure without control;
  7. Diagnosed with severe interstitial pneumonitis or pulmonary fibrosis by chest CT;
  8. Pleural effusion, ascites require to be drained;
  9. Adverse drug addiction and drug abuse, long-term alcoholics, as well as AIDS patients; patients with severe or uncontrolled complications, such as infection requiring systemic therapy, fever (≥ 38 ℃), diabetes or hypertension can not be controlled by medicine, other complications may interfere with drug therapy;
  10. Patients with a history of drug allergy (≥ CTCAE 2 level) such as shock or allergic symptoms, especially have allergic reactions to similar drugs in the past, have severe allergies reactions to drugs containing polysorbate eighty (Tween 80);
  11. Uncontrolled seizures or loss of insight due to mental disorders;
  12. Pregnant or lactating women;
  13. Researchers think improper for this trial
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01939054
Other Study ID Numbers  ICMJE BT-BC-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Binghe Xu, Chinese Academy of Medical Sciences
Study Sponsor  ICMJE Chinese Academy of Medical Sciences
Collaborators  ICMJE Biotech Pharmaceutical Co., Ltd.
Investigators  ICMJE
Principal Investigator: Binghe Xu Cancer Insititute and Hospital, CAMS
PRS Account Chinese Academy of Medical Sciences
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP