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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2015 by Binghe Xu, Chinese Academy of Medical Sciences.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01939054
First Posted: September 11, 2013
Last Update Posted: June 4, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Biotech Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Binghe Xu, Chinese Academy of Medical Sciences
  Purpose
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.

Condition Intervention Phase
Breast Cancer Drug: Nimotuzumab Drug: docetaxel Drug: capecitabine Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Binghe Xu, Chinese Academy of Medical Sciences:

Primary Outcome Measures:
  • ORR [ Time Frame: every six weeks, up to 1 year ]
    Evaluation ORR every six weeks,with RECIST 1.1.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 90
Study Start Date: September 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
Drug: docetaxel Drug: capecitabine

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).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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): NCT01939054


Contacts
Contact: Binghe Xu 86-10-88788826 xubinghe@medmail.com.cn
Contact: Peng Yuan 86-10-8778 8114 yuanpeng01@hotmail.com

Locations
China, Beijing
Cancer Institute and Hospital, Chinese Academy of Medical Sciences Recruiting
Beijing, Beijing, China, 100021
Contact: Binghe Xu, M.D.    86-10-88788826    xubinghe@medmail.com.cn   
Sub-Investigator: Peng Yuan, M.D.         
Beijing cancer hospital Not yet recruiting
Beijing, Beijing, China, 100142
Contact: huiping Li         
The General Hospital of the People's Liberation Army (PLAGH) Not yet recruiting
Beijing, Beijing, China
Contact: junlan yang         
China, Heilongjiang
Harbin Medical University Cancer Hospital Recruiting
Harbin, Heilongjiang, China
Contact: li cai         
China, Liaoning
Liaoning Cancer Hospital and Institute Not yet recruiting
Shenyang, Liaoning, China
Contact: tao sun         
China, Shanghai
FuDan University Shanghai Cancer Center Not yet recruiting
Shanghai, Shanghai, China
Contact: xichun Hu         
China, Shanxi
Xijing Hospital Not yet recruiting
Xi-an, Shanxi, China, 710032
Contact: rui ling         
China, Zhejiang
The First Affiliated Hospital of College of Medicine, Zhejiang University (First Hospital of Zhejiang Province) Not yet recruiting
Hangzhou, Zhejiang, China
Contact: peifen fu         
Zhejiang Cancer Hospital Not yet recruiting
Hangzhou, Zhejiang, China
Contact: xiaojia wang         
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Biotech Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: Binghe Xu Cancer Insititute and Hospital, CAMS
  More Information

Responsible Party: Binghe Xu, Director of Medical Oncology, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01939054     History of Changes
Other Study ID Numbers: BT-BC-001
First Submitted: August 28, 2013
First Posted: September 11, 2013
Last Update Posted: June 4, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Docetaxel
Capecitabine
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites