Vinorelbine Versus Gemcitabine Plus Vinorelbine in Metastatic Breast Cancer Patients

NCT ID: NCT00128310

Last Updated: 2023-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 252 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-01-18
• Study Completion Date: 2008-01-24

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

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. That implies a reduction in risk ratio of 40% (Hazard ratio = 1,67). Assuming a bilateral alpha error of 0.05 and beta error of 10%, and the number of events needed if 60% of patients have progressed after 1 year, the number of patients needed per treatment arm is 114. Considering a 10% post-randomization drop-out, the final number of patients is 252 (126 per arm).

Conditions

Breast Cancer; Neoplasm Metastasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A: Vinorelbine

Arm A: Vinorelbine 30 mg/m2 will be administered as an intravenous infusion over 6-10 minutes on Study Days 1 and 8.

Group Type: ACTIVE_COMPARATOR

Vinorelbine

Intervention Type: DRUG

Arm B: Vinorelbine and Gemcitabine

Arm B: Vinorelbine 30 mg/m2 will be administered as an intravenous infusion over 6-10 minutes on Study Days 1 and 8. Gemcitabine will be administered following vinorelbine at a dose of 1200 mg/m2 as an intravenous infusion over 30 minutes.

Group Type: EXPERIMENTAL

Vinorelbine

Intervention Type: DRUG

Gemcitabine

Intervention Type: DRUG

Interventions

Vinorelbine

Intervention Type: DRUG

Gemcitabine

Intervention Type: DRUG

Other Intervention Names

Navelbine; Gemzar

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

Spanish Breast Cancer Research Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Hospital San Carlos, Madrid

Locations

Spanish Breast Cancer Research Group (GEICAM)

San Sebastián de los Reyes, Madrid, Spain

Grupo Andino de Investigación en Oncología (GAICO)

Valencia, , Venezuela

Countries

Spain; Venezuela

References

Martin M, Ruiz A, Munoz M, Balil A, Garcia-Mata J, Calvo L, Carrasco E, Mahillo E, Casado A, Garcia-Saenz JA, Escudero MJ, Guillem V, Jara C, Ribelles N, Salas F, Soto C, Morales-Vasquez F, Rodriguez CA, Adrover E, Mel JR; Spanish Breast Cancer Research Group (GEICAM) trial. Gemcitabine plus vinorelbine versus vinorelbine monotherapy in patients with metastatic breast cancer previously treated with anthracyclines and taxanes: final results of the phase III Spanish Breast Cancer Research Group (GEICAM) trial. Lancet Oncol. 2007 Mar;8(3):219-25. doi: 10.1016/S1470-2045(07)70041-4.

Reference Type: DERIVED

PMID: 17329192 (View on PubMed)

Related Links

http://www.geicam.org

Click here for more information about this study

Other Identifiers

GEICAM 2000-04

Identifier Type: -

Identifier Source: org_study_id