Vinorelbine Versus Gemcitabine Plus Vinorelbine in Metastatic Breast Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00128310
Recruitment Status : Completed
First Posted : August 9, 2005
Last Update Posted : February 7, 2007
Eli Lilly and Company
Information provided by:
Spanish Breast Cancer Research Group

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Breast Cancer Neoplasm Metastasis Drug: gemcitabine Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 252 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase III Trial Comparing Vinorelbine vs. Gemcitabine Plus Vinorelbine in Patients With Advanced Breast Cancer, Previously Treated With Anthracyclines and Taxanes
Study Start Date : January 2001
Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Primary Outcome Measures :
  1. Progression-free survival in both treatment arms

Secondary Outcome Measures :
  1. Toxicity
  2. Objective response rate in both treatment arms
  3. Response duration in both treatment arms
  4. Overall survival in both treatment arms

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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-Common Toxicity Criteria [NCI-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); ALT and 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00128310

Spanish Breast Cancer Research Group (GEICAM)
San Sebastián de los Reyes, Madrid, Spain, 28700
Grupo Andino de Investigación en Oncología (GAICO)
Valencia, Venezuela
Sponsors and Collaborators
Spanish Breast Cancer Research Group
Eli Lilly and Company
Study Chair: Miguel Martín, MD. PhD. Spanish Breast Cancer Research Group (GEICAM)

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00128310     History of Changes
Other Study ID Numbers: GEICAM 2000-04
First Posted: August 9, 2005    Key Record Dates
Last Update Posted: February 7, 2007
Last Verified: February 2007

Keywords provided by Spanish Breast Cancer Research Group:
Drug-resistant metastatic breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic