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Vinorelbine Versus Gemcitabine Plus Vinorelbine in Metastatic Breast Cancer Patients

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by:
Spanish Breast Cancer Research Group
ClinicalTrials.gov Identifier:
NCT00128310
First received: August 8, 2005
Last updated: February 6, 2007
Last verified: February 2007
History of Changes
  Purpose

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 Intervention Phase
Breast Cancer
Neoplasm Metastasis
 Drug: gemcitabine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Spanish Breast Cancer Research Group:

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

Secondary Outcome Measures:
  • Toxicity
  • Objective response rate in both treatment arms
  • Response duration in both treatment arms
  • Overall survival in both treatment arms

Estimated Enrollment: 252
Study Start Date: January 2001
Estimated Study Completion Date: October 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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-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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00128310

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

Additional Information:
"Click here for more information about this study GEICAM 2000-04  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00128310     History of Changes
Other Study ID Numbers: GEICAM 2000-04
Study First Received: August 8, 2005
Last Updated: February 6, 2007
Health Authority: Spain: Spanish Agency of Medicines

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

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

ClinicalTrials.gov processed this record on May 23, 2013