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Study With Docetaxel, Carboplatin and Herceptin Versus Vinorelbine and Herceptin in HER-2 (+) Metastatic Breast Cancer Patients

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.
 
ClinicalTrials.gov Identifier: NCT00453635
Recruitment Status : Terminated (Due to poor accrual)
First Posted : March 29, 2007
Last Update Posted : March 13, 2012
Sponsor:
Collaborator:
University Hospital of Crete
Information provided by:
Hellenic Oncology Research Group

Tracking Information
First Submitted Date  ICMJE March 28, 2007
First Posted Date  ICMJE March 29, 2007
Last Update Posted Date March 13, 2012
Study Start Date  ICMJE December 2003
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 20, 2007)
Time to progression between the two treatment arms [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 28, 2007)
Time to progression between the two treatment arms
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2007)
  • Overall survival [ Time Frame: 1 year ]
  • Toxicity profile [ Time Frame: During the time of chemotherpy ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2007)
  • Response rate
  • Overall survival
  • Toxicity profile
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study With Docetaxel, Carboplatin and Herceptin Versus Vinorelbine and Herceptin in HER-2 (+) Metastatic Breast Cancer Patients
Official Title  ICMJE A Multicenter Randomized Phase II Study of First Line Treatment With Sequential Administration of Docetaxel, Carboplatin and Herceptin Versus the Administration of Vinorelbine and Herceptin Combination in HER-2 Positive Patients With Metastatic Breast Cancer
Brief Summary This trial will compare the efficacy of sequential administration of Docetaxel, Carboplatin and Herceptin versus the administration of Vinorelbine and Herceptin combination as first line treatment in HER-2 positive patients with metastatic breast cancer.
Detailed Description Herceptin, a humanized monoclonal antibody directed against the extracellular domain of the transmembrane glycoprotein HER2/neu (c-erbB-2), is a valuable option in the treatment of women with HER2-positive metastatic breast cancer. The combination of Herceptin and chemotherapy yielded significantly better results than chemotherapy alone in response, time to progression, and survival time. Whether the combination of Docetaxel, Carboplatin and Herceptin versus the administration of Vinorelbine and Herceptin combination in HER-2 positive patients with metastatic breast cancer is preferable is not yet known.
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: Docetaxel
    Docetaxel at the dose of 75mg/m^2 IV on day 1 every 3 weeks for 6 consecutive cycles
    Other Name: Taxotere
  • Drug: Carboplatin
    Carboplatin at the dose of 5 AUC IV on day 1 every 3 weeks for 6 consecutive cycles
  • Drug: Herceptin
    Herceptin 8 mg/Kg on day 1 for the first cycle and 6 mg/Kg for the 5 remaining cycles, IV, every 3 weeks
  • Drug: Vinorelbine
    Vinorelbine at the dose of 60mg/m^2 per os,weekly
    Other Name: Navelbine
Study Arms  ICMJE
  • Experimental: 1
    Docetaxel + Carboplatin + Herceptin (D/Carbo/Her)
    Interventions:
    • Drug: Docetaxel
    • Drug: Carboplatin
    • Drug: Herceptin
  • Experimental: 2
    Vinorelbine + Herceptin (VHer)
    Interventions:
    • Drug: Herceptin
    • Drug: Vinorelbine
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 Terminated
Actual Enrollment  ICMJE
 (submitted: March 12, 2012)
88
Original Enrollment  ICMJE
 (submitted: March 28, 2007)
302
Actual Study Completion Date  ICMJE November 2008
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Performance status (WHO) 0-2
  • Histologically confirmed metastatic breast adenocarcinoma (stage IV) without any prior chemotherapy received
  • HER-2 overexpression 2+ or 3+ using IHC or FISH +
  • Measurable disease not in a prior irradiation field (no other concurrent chemotherapy agents)
  • No more than 25% of myeloproductive bone marrow irradiated (more than 4 weeks since prior radiotherapy and recovered)
  • More than 6 months since prior adjuvant or neoadjuvant chemotherapy and recovered
  • No prior first line chemotherapy for metastatic disease
  • Endocrine therapy is allowed as adjuvant or first line treatment for metastatic disease
  • Paraffin block from the primary tumor available in the research lab
  • Adequate bone marrow function (absolute neutrophil count > 1000/mm^3, platelet count > 100000/mm^3, hemoglobin > 9 gr/mm^3)
  • Adequate liver (Bilirubin < 1.5 times upper limit of normal and SGOT/SGPT < 2 times upper limit of normal) and renal function (creatinine < 2mg/dl)
  • Adequate cardiac function (LVEF > 50%)
  • Informed consent

Exclusion Criteria:

  • Pregnant or nursing
  • Concurrent agents ketoconazole, macrolide antibiotics, zidovudine which may induce P-450 cytochrome
  • Positive pregnancy test
  • Motor or sensory neuropathy > grade 1 according to NCIC Τoxicity Criteria
  • Patients with brain metastatic disease who has not been irradiated or uncontrolled brain metastatic disease after irradiation
  • History of allergic reaction attributed to docetaxel
  • Psychiatric illness or social situation that would preclude study compliance
  • Other concurrent uncontrolled illness.
  • Other invasive malignancy within the past 5 years except cured basal cell skin carcinoma and cervical carcinoma in situ
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 75 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 Greece
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00453635
Other Study ID Numbers  ICMJE CT/03.08
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party D. Mavrudis, Hellenic Oncology Research Group
Study Sponsor  ICMJE Hellenic Oncology Research Group
Collaborators  ICMJE University Hospital of Crete
Investigators  ICMJE
Principal Investigator: Dimitris Mavroudis, MD University Hospital of Crete, Dep of Medical Oncology
PRS Account Hellenic Oncology Research Group
Verification Date March 2012

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