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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
Results First Received: March 23, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Metastatic Breast Cancer
Intervention: Drug: gemcitabine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
At Step 1, 6 participants each were assigned at Dose Level 1 (gemcitabine:1000 mg/ m2) and Dose Level 2 (gemcitabine:1250 mg/ m2) to determine the recommended dose for Step 2. At Step 2, an additional 56 participants received the recommended dose (Dose Level 2).

Reporting Groups
  Description
Dose Level 1 Gemcitabine at 1000 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
Dose Level 2 Gemcitabine at 1250 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.

Participant Flow:   Overall Study
    Dose Level 1     Dose Level 2  
STARTED     6     62  
COMPLETED     0     4  
NOT COMPLETED     6     58  
Protocol Violation                 0                 2  
Adverse Event                 1                 4  
Progression of Disease                 4                 42  
Lack of Efficacy                 1                 5  
Withdrawal by Subject                 0                 1  
Pathologic Aggrevation                 0                 1  
Physician Decision                 0                 3  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Dose Level 1 Gemcitabine at 1000 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
Dose Level 2 Gemcitabine at 1250 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
Total Total of all reporting groups

Baseline Measures
    Dose Level 1     Dose Level 2     Total  
Number of Participants  
[units: participants]
  6     62     68  
Age  
[units: years]
Mean ± Standard Deviation
  53.3  ± 7.45     52.4  ± 11.25     52.5  ± 10.93  
Gender  
[units: participants]
     
Female     6     62     68  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
Japan     6     62     68  
Eastern Cooperative Oncology Group (ECOG) Performance Status [1]
[units: participants]
     
0 - Fully Active     4     45     49  
1 - Ambulatory, Restricted Strenuous Activity     2     17     19  
Human Epidermal Growth Factor Receptor 2 Expression Status  
[units: participants]
     
0     2     27     29  
1+     1     20     21  
2+     2     4     6  
3+     1     9     10  
Unknown     0     2     2  
Presence of Estrogen Hormone Receptor  
[units: participants]
     
None     4     25     29  
Present     2     37     39  
Unknown     0     0     0  
Presence of Metastasis [2]
[units: participants]
     
None     0     5     5  
Lung     0     27     27  
Bone     1     24     25  
Liver     2     25     27  
Brain     0     0     0  
Lymph Node     2     23     25  
Skin     1     6     7  
Other Sites     0     13     13  
Presence of Progesterone Hormone Receptor  
[units: participant]
     
None     3     39     42  
Present     2     23     25  
Unknown     1     0     1  
Time of Latest Chemotherapy Completion  
[units: participants]
     
<3 months     2     40     42  
≥3 months and <6 months     1     6     7  
≥6 months and <1 year     3     9     12  
≥1 year and <2 years     0     3     3  
≥2 years and <3 years     0     2     2  
≥3 years before     0     2     2  
Time to Recurrence  
[units: participants]
     
<1 year     4     22     26  
≥1 year and <2 years     0     18     18  
≥2 years and <3 years     0     4     4  
≥3 years and <4 years     0     2     2  
≥4 years and < 5 years     0     2     2  
≥5 to <10 years     1     4     5  
No Recurrence     1     10     11  
Height  
[units: centimeters]
Mean ± Standard Deviation
  152.45  ± 4.05     156.43  ± 6.04     156.08  ± 5.98  
Weight  
[units: kilograms]
Mean ± Standard Deviation
  47.73  ± 1.46     57.02  ± 9.15     56.20  ± 9.13  
[1] Classifies patients according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death).
[2] Metastasis could occur in more than one site, resulting in a higher sum for all categories in the arm/group than the overall number of participants in the arm/group.



  Outcome Measures
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1.  Primary:   Tumor Response   [ Time Frame: baseline to measured progressive disease ]

2.  Secondary:   Duration of Response   [ Time Frame: time of response to progressive disease ]

3.  Secondary:   Time to Progressive Disease   [ Time Frame: baseline to measured progressive disease ]

4.  Secondary:   Survival at 1 Year   [ Time Frame: baseline to date of death from any cause, evaluate at 1 year ]

5.  Secondary:   Pharmacokinetics - Normalized Cmax   [ Time Frame: cycle 1 ]

6.  Secondary:   Pharmacokinetics - Normalized Area Under the Curve   [ Time Frame: cycle 1 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 1-800-545-5979


No publications provided


Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00191269     History of Changes
Other Study ID Numbers: 9065, B9E-JE-MB21
Study First Received: September 12, 2005
Results First Received: March 23, 2009
Last Updated: March 10, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare