Preoperative Treatment of Breast Cancer With Two Different Sequential Treatment Regimens

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00149214
First received: September 2, 2005
Last updated: March 15, 2012
Last verified: March 2012
Results First Received: February 11, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: pemetrexed
Drug: cyclophosphamide
Drug: doxorubicin
Drug: docetaxel

  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
The one participant who was randomized to pemetrexed but treated with cyclophosphamide is included in the as randomized group (pemetrexed) for the purposes of the participant flow, excluded from the efficacy analyses (per the protocol), but in the as treated group (cyclophosphamide) for safety analyses.

Reporting Groups
  Description
Pemetrexed Plus Doxorubicin, Followed by Docetaxel pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel cyclophosphamide: 600 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)

Participant Flow:   Overall Study
    Pemetrexed Plus Doxorubicin, Followed by Docetaxel     Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel  
STARTED     135 [1]   122  
COMPLETED     109 [2]   105  
NOT COMPLETED     26     17  
Adverse Event                 12                 9  
Withdrawal by Subject                 4                 1  
Physician Decision                 3                 3  
Sponsor Decision                 0                 1  
Progressive Disease                 7                 3  
[1] One patient randomized to Pemetrexed (P) was treated with Cyclophosphamide (C).
[2] The patient treated with Cyclophosphamide (C) was included in that arm (C) for safety analysis.



  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
Pemetrexed Plus Doxorubicin, Followed by Docetaxel pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel cyclophosphamide: 600 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
Total Total of all reporting groups

Baseline Measures
    Pemetrexed Plus Doxorubicin, Followed by Docetaxel     Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel     Total  
Number of Participants  
[units: participants]
  135     122     257  
Age  
[units: years]
Mean ± Standard Deviation
  49.9  ± 10.2     49.5  ± 9.7     49.7  ± 10.0  
Gender  
[units: participants]
     
Female     135     122     257  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
Spain     36     29     65  
Russian Federation     14     14     28  
Germany     74     71     145  
Italy     11     8     19  
Eastern Cooperative Oncology Group Performance Status  
[units: participants]
     
Grade 0 - Fully active     131     113     244  
Grade 1- Ambulatory; strenuous activity restricted     1     4     5  
Status Unknown     3     5     8  
Estrogen and Progesterone Receptor Status  
[units: participants]
     
At least one positive     90     78     168  
Both negative     45     44     89  
Menopausal Status  
[units: participants]
     
Unknown     0     1     1  
Pre-Menopausal     69     66     135  
Peri-Menopausal     6     7     13  
Post-Menopausal     60     48     108  
Race/Ethnicity  
[units: participants]
     
Caucasian     135     119     254  
Hispanic     0     3     3  



  Outcome Measures
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1.  Primary:   Number of Participants With a Pathological Complete Response   [ Time Frame: surgery after eight 21-day cycles of chemotherapy ]

2.  Secondary:   Number of Participants With a Clinical Tumor Response After the First Sequence of Chemotherapy   [ Time Frame: Cycles 1-4 (21-day cycles) ]

3.  Secondary:   Number of Participants With a Clinical Tumor Response After the Second Sequence of Chemotherapy   [ Time Frame: Cycles 5-8 (21-day cycles) ]

4.  Secondary:   Number of Patients With Histologically Negative Axillary Lymph Node Status at Surgery   [ Time Frame: surgery after eight 21-day cycles of chemotherapy ]

5.  Secondary:   Disease-free Survival   [ Time Frame: baseline through post surgery, follow-up for 3 years post-surgery (up to 5.2 years after randomization) ]


  Serious Adverse Events


  Other Adverse Events


  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: 1-800-545-5979


Publications of Results:

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00149214     History of Changes
Other Study ID Numbers: 7113, H3E-MC-S080
Study First Received: September 2, 2005
Results First Received: February 11, 2009
Last Updated: March 15, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices