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Neoadjuvant Sequential Administration of Two Gemcitabine Combinations in Operable Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191789
First received: September 12, 2005
Last updated: July 21, 2010
Last verified: July 2010
History of Changes
Results First Received: April 29, 2010  
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: Breast Cancer
Interventions: Drug: gemcitabine
Drug: doxorubicin
Drug: cisplatin
Procedure: surgery

  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
No text entered.

Reporting Groups
  Description
Gemcitabine+Doxorubicin+Cisplatin+Surgery

Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).

Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision.

Participant Flow:   Overall Study
    Gemcitabine+Doxorubicin+Cisplatin+Surgery  
STARTED     65  
COMPLETED     40  
NOT COMPLETED     25  
Adverse Event                 5  
Patient: Satisfactory Response                 5  
Patient/Physician: Satisfactory Response                 4  
Withdrawal by Subject                 4  
Death - Possibly Study Drug Related                 4  
Progressive Disease/Lack of Efficacy                 2  
Death - Not Study-Drug Related                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Gemcitabine+Doxorubicin+Cisplatin+Surgery

Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).

Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision.

Baseline Measures
    Gemcitabine+Doxorubicin+Cisplatin+Surgery  
Number of Participants  
[units: participants]
 		  65  
Age  
[units: years]
Median ( Full Range ) 		  46  
  ( 31 to 70 )  
Gender  
[units: participants]
 		 
Female     65  
Male     0  
Race/Ethnicity, Customized  
[units: participants]
 		 
Indian     65  
Region of Enrollment  
[units: participants]
 		 
India     65  
Diagnosis  
[units: participants]
 		 
Histopathological     12  
Cytological     53  
Disease Stage [1]
[units: participants]
 		 
Stage IIA     3  
Stage IIB     30  
Stage IIIA     18  
Stage IIIB     14  
Hormone Receptor Status [2]
[units: participants]
 		 
ER+ / PR+     27  
ER+ / PR-     8  
ER- / PR+     3  
ER- / PR-     25  
No Assessment     2  
Human Epidermal Growth Factor Receptor 2 (HER-2) Status [3]
[units: participants]
 		 
0     27  
1+     8  
2+     2  
3+     19  
Not Detected     7  
Insufficient Sample     2  
Karnofsky Performance Status Scale [4]
[units: participants]
 		 
100 - Normal no complaints; no evidence of disease     9  
90 - Normal activity; minor signs of disease     56  
Menopausal Status  
[units: participants]
 		 
Premenopausal     29  
Postmenopausal     36  
Body Surface Area [5]
[units: meters squared (m^2)]
Median ( Full Range ) 		  1.44  
  ( 1.19 to 1.77 )  
Height  
[units: centimeters (cm)]
Median ( Full Range ) 		  153  
  ( 141 to 170 )  
Largest Lesion Size  
[units: millimeters (mm)]
Median ( Full Range ) 		  30  
  ( 7.8 to 85.8 )  
Weight  
[units: kilograms (kg)]
Median ( Full Range ) 		  57  
  ( 34 to 87 )  
[1]

Stage means how big the tumor is and how far it has spread. Stages range from 0 (not spread) to IV (spread throughout the body).

Stage IIA-cancer cells found in lymph nodes, or tumor is larger than 2 cm, but less than 5 cm and not in lymph nodes; Stage IIB - tumor larger than 2 cm, but less than 5 cm and in lymph nodes, or tumor larger than 5 cm but not in lymph nodes; Stage IIIA - cancer has spread to nearby tissues; Stage IIIB - cancer has spread to chestwall and/or skin, and lymph nodes near breastbone.
[2] Status of the estrogen receptors (ER) and progesterone receptors (PR). A score of Estrogen Receptor positive (ER+) means that estrogen is causing the tumor to grow and Progesterone Receptor positive (PR+) means that progesterone is causing the tumor to grow.
[3] Status determines if there is too much HER-2 receptor protein on the surface of the breast cancer cell. Results range from 0 (negative), 1+ (negative), 2+ (borderline) to 3+ (positive).
[4] Classifies patients according to their functional impairment. Scores range from 0-100 (in increments of 10), the lower the score, the worse the survival for most serious illnesses.
[5] The calculation is from the formula of DuBois and DuBois: BSA = (Weight^0.425 x Height^0.725) x 0.007184, where weight is in kilograms and height is in centimeters.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Patients With Pathological Complete Response (Pathological Complete Response Rate)   [ Time Frame: tumor assessment at baseline and during surgery after eight 21-day treatment cycles ]
  Show Outcome Measure 1

2.  Secondary:   Summary of Deaths During Study   [ Time Frame: baseline through last cycle on study drug (eight 21-day cycles) ]
  Show Outcome Measure 2

3.  Secondary:   Progression Free Survival (PFS)   [ Time Frame: baseline to measured progressive disease or death from any cause (up to 68 months) ]
  Show Outcome Measure 3

4.  Secondary:   Overall Survival   [ Time Frame: baseline to date of death from any cause up to 68 months ]
  Show Outcome Measure 4

5.  Secondary:   Time to Treatment Failure   [ Time Frame: baseline to stopping treatment (up to 68 months) ]
  Show Outcome Measure 5

6.  Secondary:   Number of Patients Eligible for Breast Conservation Surgery at Baseline and Number of Patients Undergoing Breast Conservation Surgery   [ Time Frame: baseline, after eight 21-day cycles of study drug ]
  Show Outcome Measure 6

7.  Post-Hoc:   Number of Participants With Progressive Disease or Death at Various Time Points Throughout the Study   [ Time Frame: baseline up to 68 months ]
  Show Outcome Measure 7

8.  Post-Hoc:   Number of Participants Who Died From Any Cause at Various Time Points   [ Time Frame: baseline up to 68 months ]
  Show Outcome Measure 8

9.  Post-Hoc:   Number of Participants With Time to Treatment Failure at Various Time Points   [ Time Frame: baseline to stopping treatment (up to 68 months) ]
  Hide Outcome Measure 9

Measure Type Post-Hoc
Measure Title Number of Participants With Time to Treatment Failure at Various Time Points
Measure Description This outcome is in place of the time to treatment failure outcome. The cumulative number of participants with an event (disease progression, death as a result of any cause, or early discontinuation of treatment) are presented at various time points, as well as the number of participants at risk for the event. Participants at risk are the number of participants without disease progression, are alive, or did not discontinue treatment early at the beginning of each time point.
Time Frame baseline to stopping treatment (up to 68 months)  
Safety Issue Yes  

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.
Intent to treat population.

Reporting Groups
  Description
Gemcitabine+Doxorubicin+Cisplatin+Surgery

Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).

Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision.

Measured Values
    Gemcitabine+Doxorubicin+Cisplatin+Surgery  
Number of Participants Analyzed  
[units: participants]
 		  65  
Number of Participants With Time to Treatment Failure at Various Time Points  
[units: participants]
 		 
3 Months: Number of Patients with Event     11  
3 Months: Number of Patients at Risk     59  
6 Months: Number of Patients with Event     19  
6 Months: Number of Patients at Risk     50  
12 Months: Number of Patients with Event     25  
12 Months: Number of Patients at Risk     41  
24 Months: Number of Patients with Event     29  
24 Months: Number of Patients at Risk     36  
48 Months: Number of Patients with Event     35  
48 Months: Number of Patients at Risk     23  
68 Months: Number of Patients with Event     35  
68 Months: Number of Patients at Risk     1  

No statistical analysis provided for Number of Participants With Time to Treatment Failure at Various Time Points




  Serious Adverse Events
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  Other Adverse Events
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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.


Limitations and Caveats
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
No text entered.  


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


No publications provided


Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00191789     History of Changes
Other Study ID Numbers: 7117, B9E-MC-S329
Study First Received: September 12, 2005
Results First Received: April 29, 2010
Last Updated: July 21, 2010
Health Authority: India: Ministry of Health