Paclitaxel Followed by FEC Versus Paclitaxel and RAD001 Followed by FEC In Women With Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00499603
First received: July 9, 2007
Last updated: August 27, 2013
Last verified: August 2013
Results First Received: April 1, 2013  
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: Paclitaxel
Drug: 5-Fluorouracil
Drug: Epirubicin
Drug: Cyclophosphamide
Drug: RAD001

  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
Participants with triple negative breast cancer who were seen in the Breast Medical Oncology clinic of the MD Anderson Cancer Center were enrolled in the study prior to surgery from August 16, 2007 to September 14, 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Sixty-two (62) participants were registered but only fifty (50) were randomized. Nine patients failed the screening process, two patients withdrew consent, and one patient was discontinued due to therapy interruption for greater than 21 days.

Reporting Groups
  Description
Paclitaxel + FEC

Paclitaxel 80 mg/m^2 intravenously (IV) on day 1(+/- 2 days) of each week, followed by four cycles of combination 5-Fluorouracil at 500 mg/m^2, Epirubicin at 100 mg/m^2 and Cyclophosphamide at 500 mg/m^2 (FEC) on day 1 every 3 weeks (+/- 7 days).

5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.

Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.

Cyclophosphamide: 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.

Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.

Paclitaxel + RAD001 + FEC

Paclitaxel + RAD001 Followed by FEC (5-Fluorouracil + Epirubicin + Cyclophosphamide)

5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.

Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.

RAD001 : 30 mg by mouth weekly on Days 1, 8, & 15 for 12 cycles.

Cyclophosphamide: 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.

Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.


Participant Flow:   Overall Study
    Paclitaxel + FEC     Paclitaxel + RAD001 + FEC  
STARTED     27     23  
COMPLETED     27     22  
NOT COMPLETED     0     1  
Adverse Event                 0                 1  



  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
Paclitaxel + FEC

Paclitaxel 80 mg/m^2 intravenously (IV) on day 1(+/- 2 days) of each week, followed by four cycles of combination 5-Fluorouracil at 500 mg/m^2, Epirubicin at 100 mg/m^2 and Cyclophosphamide at 500 mg/m^2 (FEC) on day 1 every 3 weeks (+/- 7 days).

5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.

Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.

Cyclophosphamide : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.

Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.

Paclitaxel + RAD001 + FEC

Paclitaxel + RAD001 Followed by FEC (5-Fluorouracil + Epirubicin + Cyclophosphamide)

5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.

Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.

RAD001 : 30 mg by mouth weekly on Days 1, 8, & 15 for 12 cycles.

Cyclophosphamide : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.

Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.

Total Total of all reporting groups

Baseline Measures
    Paclitaxel + FEC     Paclitaxel + RAD001 + FEC     Total  
Number of Participants  
[units: participants]
  27     23     50  
Age  
[units: years]
Median ( Full Range )
  52  
  ( 30 to 65 )  
  46  
  ( 32 to 75 )  
  48  
  ( 30 to 75 )  
Gender  
[units: participants]
     
Female     27     23     50  
Male     0     0     0  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     2     0     2  
Not Hispanic or Latino     25     23     48  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     2     0     2  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     5     6     11  
White     18     17     35  
More than one race     0     0     0  
Unknown or Not Reported     2     0     2  
Region of Enrollment  
[units: participants]
     
United States     27     23     50  
Cancer Clinical Stage [1]
[units: participants]
     
T1     4     3     7  
T2     18     17     35  
T3     4     1     5  
T4     1     1     2  
Unknown or Not Reported     0     1     1  
Regional Lymph Node Stage [2]
[units: Participants]
     
N0     8     6     14  
N1     10     7     17  
N2     4     2     6  
Nx     5     7     12  
Unknown or Not Reported     0     1     1  
Breast Cancer Stage [3]
[units: Participants]
     
IIA     8     8     16  
IIB     8     6     14  
IIIA     4     2     6  
IIIB     2     0     2  
IIIC     5     7     12  
[1] Clinical staging describes the extent or severity of a person’s cancer where T1, T2, T3, T4 define the size and/or extent of the primary tumor with the higher numbers indicating more extensive disease.
[2] Regional lymph node staging illustrates the amount of cancer spread to nearby lymph nodes, notations are NX: Regional lymph nodes cannot be evaluated; N0: No regional lymph node involvement; N1, N2, N3: Degree of regional lymph node involvement (number and location of lymph nodes)
[3] Participants staged using histologically confirmed disease stages Stage IIA, IIB and IIIA, IIIB, IIIC per the American Joint Committee on Cancer (AJCC) sixth edition for breast cancer.



  Outcome Measures
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1.  Primary:   Number Participants With Inhibition of PI3K/PTEN/AKT Pathway at 48 Hours   [ Time Frame: 48 hours after start of treatment ]

2.  Secondary:   Participant Responses Per Treatment Arm at 12 Weeks   [ Time Frame: 12 weeks ]

3.  Secondary:   Participant Responses Per Treatment Arm at 24 Weeks   [ Time Frame: 24 weeks ]


  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
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Ana Gonzalez-Angulo
Organization: The University of Texas MD Anderson Cancer Center
phone: 713-792-8370
e-mail: CR_Study_Registration@mdanderson.org


No publications provided


Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00499603     History of Changes
Other Study ID Numbers: 2006-0790
Study First Received: July 9, 2007
Results First Received: April 1, 2013
Last Updated: August 27, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration