Vinorelbine Versus Gemcitabine Plus Vinorelbine in Metastatic Breast Cancer Patients

NCT00128310 | Completed Phase 3

• 1 other identifier: GEICAM 2000-04
• Study Type: interventional
• Target: 252
• Locations: 2 countries
• Sites: 2

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).

Conditions

Breast Cancer; Neoplasm Metastasis

Keywords

Drug-resistant metastatic breast cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  Progression-free survival is calculated as the time from randomization to the first observation of disease progression or date of death (whichever occurs earlier). Progression-free survival time will be censored at the time of the most recent information for patients who are still alive at the time of the last visit.

  Through study completion, an average of 1 year

Secondary Outcomes (4)

• The Number of Participants Who Experienced Adverse Events (AE)

  Through study completion, an average of 1 year

• Objective Response Rate (ORR)

  Through study completion, an average of 1 year

• Response Duration (RD)

  Through study completion, an average of 1 year

• Overall Survival (OS)

  Through study completion, an average of 1 year

Study Arms (2)

Arm A: Vinorelbine

ACTIVE COMPARATOR

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

Drug: Vinorelbine

Arm B: Vinorelbine and Gemcitabine

EXPERIMENTAL

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.

Drug: Vinorelbine; Drug: Gemcitabine

Interventions

Vinorelbine DRUG

Also known as: Navelbine

Arm A: Vinorelbine; Arm B: Vinorelbine and Gemcitabine

Gemcitabine DRUG

Also known as: Gemzar

Arm B: Vinorelbine and Gemcitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Spanish Breast Cancer Research Group: lead
• Eli Lilly and Company: collaborator

Study Sites (2)

Spanish Breast Cancer Research Group (GEICAM)

San Sebastián de los Reyes, Madrid, 28700, Spain

Location

Grupo Andino de Investigación en Oncología (GAICO)

Valencia, Venezuela

Location

Related Publications (1)

• 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.

  PMID: 17329192 DERIVED

Related Links

• Click here for more information about this study

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Interventions

Vinorelbine; Gemcitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Study Director

  Hospital San Carlos, Madrid

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2005
• First Posted: August 9, 2005
• Study Start: January 18, 2001
• Primary Completion: August 15, 2006
• Study Completion: January 24, 2008
• Last Updated: May 31, 2023

Record last verified: 2023-05

Locations

VE (1); ES (1)