Gemcitabine Monotherapy for Metastatic Breast Cancer After Anthracycline and Taxane Regimen

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191269
First received: September 12, 2005
Last updated: March 10, 2010
Last verified: March 2010

September 12, 2005
March 10, 2010
June 2005
March 2008   (final data collection date for primary outcome measure)
Tumor Response [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.
Not Provided
Complete list of historical versions of study NCT00191269 on ClinicalTrials.gov Archive Site
  • Duration of Response [ Time Frame: time of response to progressive disease ] [ Designated as safety issue: No ]
    For responders, the minimum and maximum of the duration of complete response, duration of partial response, and duration of overall response were summarized, and the median of response duration and its 95% confidence interval were calculated using the Kaplan-Meier estimation.
  • Time to Progressive Disease [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
    Time from study enrollment to first date of disease progression. Time to disease progression was censored at date of death if death was due to other cause. The minimum and maximum of this parameter were summarized, and the median time to progression and its 95% confidence interval were calculated using the Kaplan-Meier estimation.
  • Survival at 1 Year [ Time Frame: baseline to date of death from any cause, evaluate at 1 year ] [ Designated as safety issue: Yes ]
    Results are reported as number of participants alive at one year.
  • Pharmacokinetics - Normalized Cmax [ Time Frame: cycle 1 ] [ Designated as safety issue: Yes ]
    maximum gemcitabine plasma concentration normalized to 1250 milligrams per square meter of gemcitabine.
  • Pharmacokinetics - Normalized Area Under the Curve [ Time Frame: cycle 1 ] [ Designated as safety issue: Yes ]
    Area under the gemcitabine plasma concentration-time curve from time zero to infinity. Gemcitabine dose was normalized to 1250 milligrams per square meter.
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Gemcitabine Monotherapy for Metastatic Breast Cancer After Anthracycline and Taxane Regimen
A Multicenter Study of LY188011 in Anthracyclines and Taxanes Pre-treated Metastatic/Recurrent Breast Cancer

To investigate efficacy, safety and PK of GEM monotherapy after prior chemotherapy with anthracycline and taxane regimen for patients with 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
    1000 mg/m2, intravenous (IV), day 1 and day 8 every 21 days
    Other Names:
    • LY188011
    • Gemzar
  • Drug: gemcitabine
    1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days
    Other Names:
    • LY188011
    • Gemzar
  • Experimental: A
    Dose Level 1 - 1000 mg/m2
    Intervention: Drug: gemcitabine
  • Experimental: B
    Dose Level 2 - 1250 mg/m2
    Intervention: Drug: gemcitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
68
March 2010
March 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically and/or cytologically confirmed breast cancer
  • Received prior chemotherapy for metastatic breast cancer with anthracycline and taxane regimen
  • To have at least one measurable region
  • PS: 0-1
  • To have adequate organ function (bone marrow, liver and renal function)

Exclusion Criteria:

  • To have Interstitial pneumonia or pulmonary fibrosis
  • To have inflammatory carcinoma
  • Within 28 days after the latest chemotherapy or radiotherapy, 14 days after the latest hormonal/immunotherapy or 7 days after surgery
  • To have brain metastasis with symptom
  • To have severe complication (cardiac infarction, infection, drug hyper sensitivity or diabetes)
Female
20 Years to 74 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00191269
9065, B9E-JE-MB21
Yes
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
March 2010

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