Status:
COMPLETED
Vinorelbine Versus Gemcitabine Plus Vinorelbine in Metastatic Breast Cancer Patients
Lead Sponsor:
Spanish Breast Cancer Research Group
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Breast Cancer
Neoplasm Metastasis
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
This is a multicenter, randomized, prospective, Phase III study in which patients with advanced breast carcinoma previously treated with anthracyclines and taxanes will be randomly assigned to receive...
Detailed Description
The investigators assume that progression-free survival mean time for patients treated with vinorelbine will be 3 months, and for patients treated with gemcitabine plus vinorelbine will be 5 months. T...
Eligibility Criteria
Inclusion
- Histological or cytological diagnoses of breast cancer, with metastases.
- Metastatic lesions should not be curable with surgery or radiotherapy.
- Women of age \> 18.
- To have received a previous treatment with anthracyclines and taxanes.
- A maximum of 2 previous chemotherapy treatment lines for metastatic disease.
- Previous radiotherapy is allowed, whenever the radiated area is not the only disease location.
- At least 4 weeks since the last previous antineoplastic treatment; patient must have recovered from all previous toxicities.
- Performance status \< 2 in World Health Organization (WHO) scale.
- Clinically measurable, non measurable or really non measurable disease, as per Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
- Life expectancy of at least 12 weeks.
- Patients able to comply and to receive an adequate follow-up.
- Adequate bone marrow function: neutrophils ≥ 2 x 10\^9/L; platelets ≥ 100 x 10\^9/L; hemoglobin ≥ 100 g/L.
- Calcium within normal limits.
- Premenopausal women must adopt an adequate contraceptive method during the study and up to 3 months after treatment finalization.
Exclusion
- Active infection or serious concomitant disease (investigator's criteria).
- Clinical evidence of metastases in the central nervous system (CNS).
- Blastic bone lesions as only disease.
- Previous neurological toxicity grade 3-4 National Cancer Institute (NCI) Common Toxicity Criteria (CTC) v.2.0.
- Previous treatment with gemcitabine and/or vinorelbine.
- More than 2 previous chemotherapy treatment lines for metastatic disease.
- Abnormal liver function (bilirubin \> 2.0-fold upper normal limit (UNL); alanine transaminase (ALT) and aspartate transaminase (AST) \>2.5-fold UNL). In patients with hepatic metastasis, a value of ALT and AST of up to 5-fold UNL is permitted.
- Unpaired renal function (creatinine \> 2.0 mg/dL).
- Pregnancy or lactating.
- Treatment with any investigational agent in the previous 4 weeks.
- Second malignancy (except for cervix carcinoma in situ or skin carcinoma - no melanoma- with an adequate treatment). Previous malignancies are allowed if disease-free survival is superior to 5 years, except for renal carcinoma or melanoma.
- Males.
Key Trial Info
Start Date :
January 18 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 24 2008
Estimated Enrollment :
252 Patients enrolled
Trial Details
Trial ID
NCT00128310
Start Date
January 18 2001
End Date
January 24 2008
Last Update
May 31 2023
Active Locations (2)
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1
Spanish Breast Cancer Research Group (GEICAM)
San Sebastián de los Reyes, Madrid, Spain, 28700
2
Grupo Andino de Investigación en Oncología (GAICO)
Valencia, Venezuela