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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.
 
ClinicalTrials.gov Identifier: NCT00128310
Recruitment Status : Completed
First Posted : August 9, 2005
Last Update Posted : February 21, 2019
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Spanish Breast Cancer Research Group

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).

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

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).

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Study Type : Interventional  (Clinical Trial)
Actual 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
Actual Study Start Date : January 18, 2001
Actual Primary Completion Date : August 15, 2006
Actual Study Completion Date : January 24, 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Active Comparator: 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.
Drug: Vinorelbine
Other Name: Navelbine

Experimental: 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.
Drug: Vinorelbine
Other Name: Navelbine

Drug: Gemcitabine
Other Name: Gemzar




Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: Through study completion, an average of 1 year ]
    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.


Secondary Outcome Measures :
  1. The Number of Participants Who Experienced Adverse Events (AE) [ Time Frame: Through study completion, an average of 1 year ]
    Safety was assessed by standard clinical and laboratory tests. Adverse events grade were defined by the NCI CTCAE v2.0.

  2. Objective Response Rate (ORR) [ Time Frame: Through study completion, an average of 1 year ]
    Tumor response will be assessed using RECIST criteria. The best response across all treatment will be recorded. ORR is defined as the percentage of patients with a complete or partial response out of the patients who had measurable disease at baseline.

  3. Response Duration (RD) [ Time Frame: Through study completion, an average of 1 year ]
    RD is defined as the time from the date when the measurement criteria are met for complete response (CR) or partial response (PR) (whichever status is recorded first) until the date of first observation of disease progression or death occurred. For responding patients not known to have died as of the data cut-off date and who do not have progression, duration of response will be censored at the date of last visit with adequate assessment. For responding patients who receive subsequent anticancer therapy (after discontinuation from the study treatment) prior to progression, duration of response will be censored at the date of last visit with adequate assessment prior to the initiation of post-discontinuation anticancer therapy.

  4. Overall Survival (OS) [ Time Frame: Through study completion, an average of 1 year ]
    OS was defined as the time elapsed from first treatment until death from any cause.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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 (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.

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 ClinicalTrials.gov identifier (NCT number): NCT00128310


Locations
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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
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Study Director: Study Director Hospital Clínico San Carlos

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Spanish Breast Cancer Research Group
ClinicalTrials.gov Identifier: NCT00128310    
Other Study ID Numbers: GEICAM 2000-04
First Posted: August 9, 2005    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019
Keywords provided by Spanish Breast Cancer Research Group:
Drug-resistant metastatic breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Gemcitabine
Vinorelbine
Antimetabolites, Antineoplastic
Antimetabolites
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
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators