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

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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

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Docetaxel Drug: Carboplatin Drug: Herceptin Drug: Vinorelbine Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2003
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: 1
Docetaxel + Carboplatin + Herceptin (D/Carbo/Her)
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

Experimental: 2
Vinorelbine + Herceptin (VHer)
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




Primary Outcome Measures :
  1. Time to progression between the two treatment arms [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 1 year ]
  2. Toxicity profile [ Time Frame: During the time of chemotherpy ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT00453635


Locations
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Greece
University Hospital of Crete
Heraklion, Crete, Greece, 71110
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupolis, Greece
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology
Athens, Greece
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
Athens, Greece
401 Military Hospital of Athens
Athens, Greece
Air Forces Military Hospital of Athens
Athens, Greece
Marika Iliadis" Hospital of Athens, Dep of Medical Oncology
Athens, Greece
State General Hospital of Larissa
Athens, Greece
"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
Piraeus, Greece
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
Thessaloniki, Greece
Sponsors and Collaborators
Hellenic Oncology Research Group
University Hospital of Crete
Investigators
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Principal Investigator: Dimitris Mavroudis, MD University Hospital of Crete, Dep of Medical Oncology

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Responsible Party: D. Mavrudis, Hellenic Oncology Research Group
ClinicalTrials.gov Identifier: NCT00453635     History of Changes
Other Study ID Numbers: CT/03.08
First Posted: March 29, 2007    Key Record Dates
Last Update Posted: March 13, 2012
Last Verified: March 2012

Keywords provided by Hellenic Oncology Research Group:
Cancer
Breast cancer
First line treatment
Docetaxel
Carboplatin
Herceptin
Vinorelbine

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carboplatin
Docetaxel
Vinorelbine
Trastuzumab
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Antineoplastic Agents, Immunological