Randomized Phase III Trial Comparing Vinorelbine vs. Gemcitabine Plus Vinorelbine in Patients With Advanced Breast Cancer, Previously Treated With Anthracyclines and Taxanes

GEICAM 2000-04

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 one of two treatment options: vinorelbine (Arm A) or gemcitabine plus vinorelbine (Arm B).

2001-01-18

2006-08-15

2008-01-24

Completed

Early phase I

252

Inclusion Criteria: * 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 Criteria: * 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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 252, 'type': 'ACTUAL'}}

2023-05-31