Vinorelbine Versus Gemcitabine Plus Vinorelbine in Metastatic Breast Cancer Patients

• Status: Completed
• Trial end date: 2008-01-24
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Spanish Breast Cancer Research Group
• Collaborator: Eli Lilly and Company
• Treatments: Gemcitabine; Vinorelbine

Criteria

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.