Efficacy Study of Gemcitabine-Paclitaxel to Treat Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00316199
First received: April 18, 2006
Last updated: June 12, 2009
Last verified: June 2009

April 18, 2006
June 12, 2009
April 2006
April 2008   (final data collection date for primary outcome measure)
Best Overall Tumor Response [ Time Frame: baseline to measured progressive disease (tumor assessments were performed every 2 cycles during study therapy, or 3 months during post-therapy until disease progression, or up to 12 months after enrollment) ] [ Designated as safety issue: No ]
To determine the response rate of the gemcitabine-paclitaxel combination when administered on a 3-weekly schedule in Chinese patients with unresectable, locally recurrent breast cancer or metastatic breast cancer.
Complete list of historical versions of study NCT00316199 on ClinicalTrials.gov Archive Site
  • Time to Treatment Failure [ Time Frame: baseline to stopping treatment ] [ Designated as safety issue: Yes ]
  • Progression-Free Survival [ Time Frame: baseline to measured progressive disease or death (tumor assessments were performed every 2 cycles during study therapy, or 3 months during post-therapy until disease progression, or up to 12 months after enrollment) ] [ Designated as safety issue: No ]
  • Duration of Response [ Time Frame: time of response to measured progressive disease or death (tumor assessments were performed every 2 cycles during study therapy, or 3 months during post-therapy until disease progression, or up to 12 months after enrollment) ] [ Designated as safety issue: No ]
  • Overall Survival Probability [ Time Frame: baseline to date of death from any cause ] [ Designated as safety issue: Yes ]
  • time to treatment failure
  • time to overall disease progression
  • duration of response for responding patients
  • the quantitative and qualitative toxicity
  • overall survival.
Not Provided
Not Provided
 
Efficacy Study of Gemcitabine-Paclitaxel to Treat Metastatic Breast Cancer
Phase II Study of Gemcitabine-Paclitaxel 3-Weekly Schedule as First-Line Treatment in Metastatic Breast Cancer After Anthracycline Failure

The purpose of this study is to determine the response rate to a gemcitabine-paclitaxel combination administered on a 3-weekly schedule in Chinese patients with unresectable, locally recurrent breast cancer or metastatic breast cancer.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Breast Cancer
  • Drug: gemcitabine
    1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression
    Other Names:
    • LY188011
    • Gemzar
  • Drug: paclitaxel
    175 mg/m2, intravenous (IV), every 21 days until disease progression
Experimental: A
Interventions:
  • Drug: gemcitabine
  • Drug: paclitaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
April 2008
April 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Female patients of Chinese origin with histologically or cytologically proven diagnosis of breast cancer.
  • Unresectable, locally recurrent breast cancer or stage IV disease.
  • Have at least one measurable lesion as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
  • Performance Status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Scale
  • Treatment with an anthracycline-based chemotherapy regimen in the adjuvant/neoadjuvant setting with subsequent disease relapse.

Exclusion Criteria:

  • Prior chemotherapy for unresectable, locally advanced breast cancer or metastatic disease.
  • Concurrent administration of any other tumor therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy.
  • Known or suspected brain metastasis or second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
  • Active infection or other serious condition.
  • Pregnant or breastfeeding.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00316199
9803, B9E-MC-JHST
No
Chief Medical Officer, Eli Lilly
Eli Lilly and Company
Not Provided
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP