Back to resultsStudy With Docetaxel, Carboplatin and Herceptin Versus Vinorelbine and Herceptin in HER-2 (+) Metastatic Breast Cancer Patients
Primary Purpose
Breast Cancer
Status
Terminated
Phase
Phase 2
Locations
Greece
Study Type
Interventional
Intervention
Docetaxel
Carboplatin
Herceptin
Vinorelbine
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Cancer, Breast cancer, First line treatment, Docetaxel, Carboplatin, Herceptin, Vinorelbine
Eligibility 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
Sites / Locations
- University Hospital of Crete
- University General Hospital of Alexandroupolis, Dep of Medical Oncology
- "IASO" General Hospital of Athens, 1st Dep of Medical Oncology
- "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
- 401 Military Hospital of Athens
- Air Forces Military Hospital of Athens
- Marika Iliadis" Hospital of Athens, Dep of Medical Oncology
- State General Hospital of Larissa
- "Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
- "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
Docetaxel + Carboplatin + Herceptin (D/Carbo/Her)
Vinorelbine + Herceptin (VHer)
Outcomes
Primary Outcome Measures
Time to progression between the two treatment arms
Secondary Outcome Measures
Overall survival
Toxicity profile
Full Information
NCT ID
NCT00453635
First Posted
March 28, 2007
Last Updated
March 12, 2012
Sponsor
Hellenic Oncology Research Group
Collaborators
University Hospital of Crete
1. Study Identification
Unique Protocol Identification Number
NCT00453635
Brief Title
Study With Docetaxel, Carboplatin and Herceptin Versus Vinorelbine and Herceptin in HER-2 (+) Metastatic Breast Cancer Patients
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 Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Terminated
Why Stopped
Due to poor accrual
Study Start Date
December 2003 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hellenic Oncology Research Group
Collaborators
University Hospital of Crete
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Cancer, Breast cancer, First line treatment, Docetaxel, Carboplatin, Herceptin, Vinorelbine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Docetaxel + Carboplatin + Herceptin (D/Carbo/Her)
Arm Title
2
Arm Type
Experimental
Arm Description
Vinorelbine + Herceptin (VHer)
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Taxotere
Intervention Description
Docetaxel at the dose of 75mg/m^2 IV on day 1 every 3 weeks for 6 consecutive cycles
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Carboplatin at the dose of 5 AUC IV on day 1 every 3 weeks for 6 consecutive cycles
Intervention Type
Drug
Intervention Name(s)
Herceptin
Intervention Description
Herceptin 8 mg/Kg on day 1 for the first cycle and 6 mg/Kg for the 5 remaining cycles, IV, every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Vinorelbine
Other Intervention Name(s)
Navelbine
Intervention Description
Vinorelbine at the dose of 60mg/m^2 per os,weekly
Primary Outcome Measure Information:
Title
Time to progression between the two treatment arms
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
1 year
Title
Toxicity profile
Time Frame
During the time of chemotherpy
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dimitris Mavroudis, MD
Organizational Affiliation
University Hospital of Crete, Dep of Medical Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Crete
City
Heraklion
State/Province
Crete
ZIP/Postal Code
71110
Country
Greece
Facility Name
University General Hospital of Alexandroupolis, Dep of Medical Oncology
City
Alexandroupolis
Country
Greece
Facility Name
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology
City
Athens
Country
Greece
Facility Name
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
City
Athens
Country
Greece
Facility Name
401 Military Hospital of Athens
City
Athens
Country
Greece
Facility Name
Air Forces Military Hospital of Athens
City
Athens
Country
Greece
Facility Name
Marika Iliadis" Hospital of Athens, Dep of Medical Oncology
City
Athens
Country
Greece
Facility Name
State General Hospital of Larissa
City
Athens
Country
Greece
Facility Name
"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
City
Piraeus
Country
Greece
Facility Name
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
City
Thessaloniki
Country
Greece
12. IPD Sharing Statement
Learn more about this trial
Study With Docetaxel, Carboplatin and Herceptin Versus Vinorelbine and Herceptin in HER-2 (+) Metastatic Breast Cancer Patients
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