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

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ClinicalTrials.gov Identifier: NCT00499603
Recruitment Status : Unknown
Verified September 2016 by M.D. Anderson Cancer Center.
Recruitment status was:  Active, not recruiting
First Posted : July 11, 2007
Results First Posted : October 31, 2013
Last Update Posted : November 1, 2016
Sponsor:
Collaborators:
Novartis
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: Paclitaxel
Drug: 5-Fluorouracil
Drug: Epirubicin
Drug: Cyclophosphamide
Drug: RAD001
Enrollment 62
Recruitment Details 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 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.
Arm/Group Title Paclitaxel + FEC Paclitaxel + RAD001 + FEC
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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 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.

Period Title: Overall Study
Started 27 23
Completed 27 22
Not Completed 0 1
Reason Not Completed
Adverse Event             0             1
Arm/Group Title Paclitaxel + FEC Paclitaxel + RAD001 + FEC Total
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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 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 of all reporting groups
Overall Number of Baseline Participants 27 23 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 27 participants 23 participants 50 participants
52
(30 to 65)
46
(32 to 75)
48
(30 to 75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 23 participants 50 participants
Female
27
 100.0%
23
 100.0%
50
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 23 participants 50 participants
Hispanic or Latino
2
   7.4%
0
   0.0%
2
   4.0%
Not Hispanic or Latino
25
  92.6%
23
 100.0%
48
  96.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 23 participants 50 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   7.4%
0
   0.0%
2
   4.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
5
  18.5%
6
  26.1%
11
  22.0%
White
18
  66.7%
17
  73.9%
35
  70.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   7.4%
0
   0.0%
2
   4.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 27 participants 23 participants 50 participants
27 23 50
Cancer Clinical Stage   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 27 participants 23 participants 50 participants
T1 4 3 7
T2 18 17 35
T3 4 1 5
T4 1 1 2
Unknown or Not Reported 0 1 1
[1]
Measure Description: 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.
Regional Lymph Node Stage   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 27 participants 23 participants 50 participants
N0 8 6 14
N1 10 7 17
N2 4 2 6
Nx 5 7 12
Unknown or Not Reported 0 1 1
[1]
Measure Description: 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)
Breast Cancer Stage   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 27 participants 23 participants 50 participants
IIA 8 8 16
IIB 8 6 14
IIIA 4 2 6
IIIB 2 0 2
IIIC 5 7 12
[1]
Measure Description: 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.
1.Primary Outcome
Title Number Participants With Inhibition of PI3K/PTEN/AKT Pathway at 48 Hours
Hide Description Number of participants with inhibition of the PI3K/PTEN/AKT pathway at 48 hours after the start of treatment, regardless of the status of the pathway at the time of randomization. Molecular changes (inhibition/activation) of the PI3K/PTEN/AKT pathway evaluated using reverse phase protein arrays (RPPA) where fine-needle aspirations (FNAs) from the primary breast cancer obtained pretreatment, and at 48 hours. Bioinformatics cluster analysis of arrays used to define molecular changes as inhibition or activation where pathways called 'active' with presence of 2 or more phosphorilated pathway proteins (pAKT, pmTOR, pGSK3, pS6K1, pS6), and 'inhibited' with one or none phosphorilated pathway proteins present.
Time Frame 48 hours after start of treatment
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Hide Analysis Population Description
Participants were randomly assigned 1:1 to receive T-FEC or TR-FEC using a balanced block design stratified by disease stage and menopausal status. One participant in Arm 2 started treatment but had untolerable side effects and was taken off the study and thus was considered inevaluable.
Arm/Group Title Paclitaxel + FEC Paclitaxel + RAD001 + FEC
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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 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.

Overall Number of Participants Analyzed 27 22
Measure Type: Number
Unit of Measure: participants
27 22
2.Secondary Outcome
Title Participant Responses Per Treatment Arm at 12 Weeks
Hide Description Radiographic criteria of response based on regional ultrasound examination (decrease in size of the primary tumor and/or fatty replacement in regional lymph nodes), and includes partial response and complete response. A decrease in size of the product of the two largest dimensions =/> 50% considered a partial response (PR), and a complete disappearance of the primary tumor by physical exam and or ultrasound and normalization of the lymph nodes by ultrasound will be considered a complete clinical response (CR). Stable Disease (SD) is carcinoma neither decreasing nor increasing in extent or severity, and Progression of disease (PD) defined as 30% increase in size primary tumor and/or lymph nodes on physical exam and/or ultrasound.
Time Frame 12 weeks
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Hide Analysis Population Description
Participants who did not complete the entire 12 week of paclitaxel +/- RAD001 or the entire 4 cycles of FEC are evaluable for response.
Arm/Group Title Paclitaxel + FEC Paclitaxel + RAD001 + FEC
Hide Arm/Group Description:

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 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.

Overall Number of Participants Analyzed 27 23
Measure Type: Number
Unit of Measure: participants
CR 3 0
PR 5 11
SD 16 11
PD 3 1
3.Secondary Outcome
Title Participant Responses Per Treatment Arm at 24 Weeks
Hide Description Radiographic criteria of response based on regional ultrasound examination (decrease in size of the primary tumor and/or fatty replacement in regional lymph nodes), and includes partial response and complete response. A decrease in size of the product of the two largest dimensions =/> 50% considered a partial response (PR), and a complete disappearance of the primary tumor by physical exam and or ultrasound and normalization of the lymph nodes by ultrasound will be considered a complete clinical response (CR). Stable Disease (SD) is carcinoma neither decreasing nor increasing in extent or severity, and Progression of disease (PD) defined as 30% increase in size primary tumor and/or lymph nodes on physical exam and/or ultrasound.
Time Frame 24 weeks
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Hide Analysis Population Description
Participants who did not complete the entire 12 week of paclitaxel +/- RAD001 or the entire 4 cycles of FEC are evaluable for response.
Arm/Group Title Paclitaxel + FEC Paclitaxel + RAD001 + FEC
Hide Arm/Group Description:

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 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.

Overall Number of Participants Analyzed 27 23
Measure Type: Number
Unit of Measure: participants
CR 4 2
PR 16 11
SD 7 7
PD 0 3
Time Frame 3 years and 9 months
Adverse Event Reporting Description Serious Adverse Events reported include Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 and Grade 4 combined within each arm. Other Adverse Events were not assessed.
 
Arm/Group Title Paclitaxel + FEC Paclitaxel + RAD001 + FEC
Hide Arm/Group Description

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 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.

All-Cause Mortality
Paclitaxel + FEC Paclitaxel + RAD001 + FEC
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Paclitaxel + FEC Paclitaxel + RAD001 + FEC
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   27/27 (100.00%)      23/23 (100.00%)    
Blood and lymphatic system disorders     
Fatigue  1 [1]  2/27 (7.41%)  2 4/23 (17.39%)  4
Neutropenia  1  11/27 (40.74%)  11 12/23 (52.17%)  12
Increased leukocytes  1  3/27 (11.11%)  3 4/23 (17.39%)  4
Anemia  1  1/27 (3.70%)  1 4/23 (17.39%)  4
Lymphopenia  1  1/27 (3.70%)  1 0/23 (0.00%)  0
Thrombocytopenia  1  2/27 (7.41%)  2 1/23 (4.35%)  1
Gastrointestinal disorders     
GI Disturbaces  1  5/27 (18.52%)  5 6/23 (26.09%)  6
Small bowel obstruction  1  1/27 (3.70%)  1 0/23 (0.00%)  0
General disorders     
Nail changes  1  0/27 (0.00%)  0 1/23 (4.35%)  1
Edema of extremities  1  1/27 (3.70%)  1 0/23 (0.00%)  0
Syncope  1  1/27 (3.70%)  1 0/23 (0.00%)  0
Infections and infestations     
Infection  1  0/27 (0.00%)  0 3/23 (13.04%)  3
Investigations     
Hyperglycemia  1  1/27 (3.70%)  1 0/23 (0.00%)  0
Hypokalemia  1  0/27 (0.00%)  0 1/23 (4.35%)  1
Musculoskeletal and connective tissue disorders     
Pain  1  2/27 (7.41%)  2 3/23 (13.04%)  3
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolus  1  0/27 (0.00%)  0 1/23 (4.35%)  1
Skin and subcutaneous tissue disorders     
Rash  1  1/27 (3.70%)  1 2/23 (8.70%)  2
Vascular disorders     
Neuropathy  1  1/27 (3.70%)  1 1/23 (4.35%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Combined CTCAE Grade 3 & 4 events
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Paclitaxel + FEC Paclitaxel + RAD001 + FEC
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/0      0/0    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Research Operations, Office of VP Clinical Research
Organization: The University of Texas MD Anderson Cancer Center
Phone: 713-792-7734
EMail: CR_Study_Registration@mdanderson.org
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00499603     History of Changes
Other Study ID Numbers: 2006-0790
NCI-2012-01514 ( Registry Identifier: NCI CTRP )
1K23CA121994-1 ( Other Grant/Funding Number: NCI )
1K23CA121994 ( U.S. NIH Grant/Contract )
First Submitted: July 9, 2007
First Posted: July 11, 2007
Results First Submitted: April 1, 2013
Results First Posted: October 31, 2013
Last Update Posted: November 1, 2016