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
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Neoplasm Metastasis||Drug: Vinorelbine Drug: Gemcitabine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||252 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
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.
Other Name: Navelbine
Other Name: Gemzar
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Spanish Breast Cancer Research Group (GEICAM)|
|San Sebastián de los Reyes, Madrid, Spain, 28700|
|Grupo Andino de Investigación en Oncología (GAICO)|
|Study Director:||Study Director||Hospital Clínico San Carlos|