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Trial record 84 of 99 for:    FEC

Evaluation of Differing Taxanes/Taxane Combinations on the Outcome of Patients With Operable Breast Cancer

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ClinicalTrials.gov Identifier: NCT00050167
Recruitment Status : Completed
First Posted : November 27, 2002
Results First Posted : August 5, 2011
Last Update Posted : August 29, 2011
Sponsor:
Collaborator:
Roche Pharma AG
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: Docetaxel
Drug: Capecitabine
Enrollment 603
Recruitment Details Recruitment period from November 20, 2002 to July 2, 2008. All recruitment done at UT MD Anderson Cancer Center.
Pre-assignment Details Planned accrual was 930 participants, only 601 were found eligible.
Arm/Group Title Weekly Paclitaxel (WP) Docetaxel and Capecitabine (DX)
Hide Arm/Group Description Weekly Paclitaxel for 12 weeks followed by Fluorouracil + Epirubicin + Cyclophosphamide (FEC) every 3 weeks for 4 cycles Docetaxel + Capecitabine days 1-14 every 3 weeks for 4 cycles followed by FEC for 4 cycles.
Period Title: Overall Study
Started 302 301
Completed 301 300
Not Completed 1 1
Reason Not Completed
not eligible not invasive             1             1
Arm/Group Title Weekly Paclitaxel (WP) Docetaxel and Capecitabine (DX) Total
Hide Arm/Group Description Weekly Paclitaxel for 12 weeks followed by Fluorouracil + Epirubicin + Cyclophosphamide (FEC) every 3 weeks for 4 cycles Docetaxel + Capecitabine days 1-14 every 3 weeks for 4 cycles followed by FEC for 4 cycles. Total of all reporting groups
Overall Number of Baseline Participants 302 301 603
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 302 participants 301 participants 603 participants
50
(42 to 57)
50
(42 to 57)
50
(42 to 57)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 302 participants 301 participants 603 participants
Female
302
 100.0%
301
 100.0%
603
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 302 participants 301 participants 603 participants
302 301 603
1.Primary Outcome
Title Percentage of Participants With Reoccurrence
Hide Description Percentage of participants where number with local recurrence, distant metastasis, or death of any cause at 50 months is divided by total number of participants and used as primary efficacy end point to compare paclitaxel to combination docetaxel and capecitabine in breast cancer treatment for preventing recurrence (return of cancer).
Time Frame Median of 50 months
Hide Outcome Measure Data
Hide Analysis Population Description

(WP Arm):301 included in the intent to treat analysis and 297 included in the safety analysis.

(DX Arm):300 included in the intent to treat analysis and 292 included in the safety analysis.

Arm/Group Title Weekly Paclitaxel (WP) Docetaxel and Capecitabine (DX)
Hide Arm/Group Description:
Weekly Paclitaxel for 12 weeks followed by Fluorouracil + Epirubicin + Cyclophosphamide (FEC) every 3 weeks for 4 cycles
Docetaxel + Capecitabine days 1-14 every 3 weeks for 4 cycles followed by FEC for 4 cycles.
Overall Number of Participants Analyzed 301 300
Log Mean (95% Confidence Interval)
Unit of Measure: participants
90.7
(86.4 to 93.7)
87.5
(82.7 to 91.1)
2.Secondary Outcome
Title Proportion of Participants With Pathological Complete Response
Hide Description Safety of 2 Different Treatments determined by proportion of participants who achieved pathological complete response (pCR) between two different treatments; where pCR was defined as no histopathologic evidence of any residual invasive cancer cells in the breast and axillary lymph nodes.
Time Frame 7 Years
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Treatment Effectiveness at Eradicating Tumor in the Breast and Lymph Nodes
Hide Description Effectiveness defined as proportion of patients who were able to have breast conserving surgery (BCS) after preoperative therapy compared to total number of participants.
Time Frame 7 years
Outcome Measure Data Not Reported
Time Frame 8 years and 5 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Weekly Paclitaxel (WP) Docetaxel and Capecitabine (DX)
Hide Arm/Group Description Weekly Paclitaxel for 12 weeks followed by Fluorouracil + Epirubicin + Cyclophosphamide (FEC) every 3 weeks for 4 cycles Docetaxel + Capecitabine days 1-14 every 3 weeks for 4 cycles followed by FEC for 4 cycles.
All-Cause Mortality
Weekly Paclitaxel (WP) Docetaxel and Capecitabine (DX)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Weekly Paclitaxel (WP) Docetaxel and Capecitabine (DX)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   81/301 (26.91%)      293/300 (97.67%)    
Blood and lymphatic system disorders     
Neutropenia  1  2/297 (0.67%)  2 45/293 (15.36%)  45
Cardiac disorders     
Fluid retention  1  1/297 (0.34%)  1 0/293 (0.00%)  0
Gastrointestinal disorders     
Nausea  1  5/297 (1.68%)  5 12/293 (4.10%)  12
Vomiting  1  0/297 (0.00%)  0 5/293 (1.71%)  5
Diarrhea  1  12/297 (4.04%)  12 17/293 (5.80%)  17
Constipation  1  2/297 (0.67%)  2 6/293 (2.05%)  6
General disorders     
Fatigue  1  25/297 (8.42%)  25 66/293 (22.53%)  66
Alopecia  1  0/297 (0.00%)  0 0/293 (0.00%)  0
Immune system disorders     
Allergic reaction  1  2/297 (0.67%)  2 4/293 (1.37%)  4
Infections and infestations     
Stomatitis  1  0/297 (0.00%)  0 5/293 (1.71%)  5
Neutropenic Infection  1  2/297 (0.67%)  2 20/293 (6.83%)  20
Neutropenic Fever  1  0/297 (0.00%)  0 13/293 (4.44%)  13
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/297 (0.00%)  0 3/293 (1.02%)  3
Myalgia  1  19/297 (6.40%)  19 32/293 (10.92%)  32
Nervous system disorders     
Peripheral Neurotoxicity  1  7/297 (2.36%)  7 14/293 (4.78%)  14
Skin and subcutaneous tissue disorders     
Skin rash  1  3/297 (1.01%)  3 1/293 (0.34%)  1
Hand foot syndrome  1  1/297 (0.34%)  1 54/293 (18.43%)  54
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (2.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Weekly Paclitaxel (WP) Docetaxel and Capecitabine (DX)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   297/301 (98.67%)      293/300 (97.67%)    
Blood and lymphatic system disorders     
Neutropenia  1  30/297 (10.10%)  30 9/293 (3.07%)  9
Neutropenic Infection  1  0/297 (0.00%)  0 0/293 (0.00%)  0
Fluid Retention  1  3/297 (1.01%)  3 8/293 (2.73%)  8
Gastrointestinal disorders     
Nausea  1  64/297 (21.55%)  64 131/293 (44.71%)  131
Vomiting  1  24/297 (8.08%)  24 41/293 (13.99%)  41
Stomatitis  1  31/297 (10.44%)  31 118/293 (40.27%)  118
Diarrhea  1  55/297 (18.52%)  55 85/293 (29.01%)  85
Constipation  1  27/297 (9.09%)  27 50/293 (17.06%)  50
General disorders     
fatigue  1  146/297 (49.16%)  146 169/293 (57.68%)  169
Immune system disorders     
Allergic reaction  1  4/297 (1.35%)  4 6/293 (2.05%)  6
Infections and infestations     
Neutropenic Fever  1  0/297 (0.00%)  0 0/293 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia  1  10/297 (3.37%)  10 20/293 (6.83%)  20
Myalgias  1  109/297 (36.70%)  109 137/293 (46.76%)  137
Nervous system disorders     
Peripheral Neurotoxicity  1  68/297 (22.90%)  68 64/293 (21.84%)  64
Skin and subcutaneous tissue disorders     
Alopecia  1  239/297 (80.47%)  239 266/293 (90.78%)  266
Skin rash  1  77/297 (25.93%)  77 43/293 (14.68%)  43
Hand Foot Syndrome  1  5/297 (1.68%)  5 72/293 (24.57%)  72
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (2.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Aman Buzdar, M.D./Professor
Organization: UT MD Anderson Cancer Center
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00050167     History of Changes
Other Study ID Numbers: ID01-580
First Submitted: November 25, 2002
First Posted: November 27, 2002
Results First Submitted: July 7, 2011
Results First Posted: August 5, 2011
Last Update Posted: August 29, 2011