Status:
COMPLETED
Vinorelbine and Gemcitabine Versus Capecitabine in Pretreated Metastatic Breast Cancer
Lead Sponsor:
Hellenic Oncology Research Group
Collaborating Sponsors:
University Hospital of Crete
Conditions:
Breast Cancer
Eligibility:
FEMALE
19-75 years
Phase:
PHASE3
Brief Summary
The combination of vinorelbine and gemcitabine seems to be an important part of the chemotherapy regimens used in metastatic breast cancer patients following treatment failure with the combination of ...
Detailed Description
This trial will compare the efficacy of combination treatment with Vinorelbine and Gemcitabine versus Capecitabine monotherapy in metastatic breast cancer patients following treatment failure with the...
Eligibility Criteria
Inclusion
- Age 19-75 years.
- Performance status World Health Organization (WHO) 0-2.
- Histologically confirmed breast adenocarcinoma.
- Clinical or radiological evidence of metastatic disease that has progressed after combination treatment of a taxane and an anthracycline (Taxotere + Mitoxantrone or Taxotere + Farmorubicine).
- Measurable disease.
- No metastatic central nervous system (CNS) disease.
- Less than 25% of myeloproductive bone marrow irradiated.
- 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 \< 2 mg/dl).
- Informed consent.
Exclusion
- Pregnancy or nursing.
- Positive pregnancy test.
- Psychiatric illness or social situation that would preclude study compliance.
- Other concurrent uncontrolled illness.
- Other invasive malignancy within the past 5 years except nonmelanoma skin cancer.
Key Trial Info
Start Date :
April 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2009
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT00431106
Start Date
April 1 2002
End Date
January 1 2009
Last Update
September 28 2009
Active Locations (10)
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1
University Hospital of Crete
Heraklion, Crete, Greece, 71110
2
University General Hospital of Alexandroupolis, Dept. of Medical Oncology
Alexandroupoli, Greece
3
"IASO" General Hospital of Athens, 1st Dept. of Medical Oncology
Athens, Greece
4
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dept. of Internal Medicine
Athens, Greece