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Trial record 1 of 1 for:    GEICAM 2003-02
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FAC Versus FAC Plus Weekly Paclitaxel as Adjuvant Treatment of Node Negative High Risk Breast Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00129389
Recruitment Status : Completed
First Posted : August 11, 2005
Results First Posted : July 12, 2019
Last Update Posted : July 12, 2019
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Spanish Breast Cancer Research Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: Fluorouracil
Drug: Doxorubicin
Drug: Cyclophosphamide
Drug: Paclitaxel
Enrollment 1925
Recruitment Details 1925 patients from 67 Spanish sites were assigned to receive FAC-wP (n=951) or FAC (n=974). 8 patients received no treatment (5 FAC-wP, 3 FAC), and 17 were not treated with the study medication to which they were randomly assigned (1 FAC, 16 FAC-wP). A total of 1,917 patients were evaluable for safety (931 FAC-wP, 986 FAC).
Pre-assignment Details  
Arm/Group Title Arm A: FAC Arm B: FAC-wP
Hide Arm/Group Description FAC X 6 The standard arm consisted of six cycles of FAC (fluorouracil 500 mg/m2, doxorubicin 50mg/m2, and cyclophosphamide 500mg/m2) administered once every 3 weeks. FAC X 4 + 8 weekly Paclitaxel (wP) Patients in the experimental arm received four cycles of the FAC regimen followed by eight weekly administrations of paclitaxel (100mg/m2 per dose)
Period Title: Overall Study
Started 974 951
Completed 941 [1] 811 [2]
Not Completed 33 140
Reason Not Completed
Adverse Event             19             87
Death             0             1
Lost to Follow-up             2             1
Physician Decision             0             4
Protocol Violation             0             6
Withdrawal by Subject             9             23
Relapse             1             0
Not eligible             1             2
Crossed to the other arm             1             16
[1]
1 patient was crossed from arm A to B by error. 16 patients were crossed from arm B, to A by error.
[2]
16 patients were crossed from arm B to A by error. 1 patient was crossed from arm A to B by error.
Arm/Group Title Arm A: FAC Arm B: FAC-wP Total
Hide Arm/Group Description FAC X 6 The standard arm consisted of six cycles of FAC (fluorouracil 500 mg/m2, doxorubicin 50mg/m2, and cyclophosphamide 500mg/m2) administered once every 3 weeks. FAC X 4 + 8 weekly Paclitaxel (wP) Patients in the experimental arm received four cycles of the FAC regimen followed by eight weekly administrations of paclitaxel (100mg/m2 per dose) Total of all reporting groups
Overall Number of Baseline Participants 974 951 1925
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 974 participants 951 participants 1925 participants
50.95
(24 to 75)
50.89
(24 to 72)
50.92
(24 to 75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 974 participants 951 participants 1925 participants
Female
974
 100.0%
951
 100.0%
1925
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 974 participants 951 participants 1925 participants
Caucasian
960
  98.6%
935
  98.3%
1895
  98.4%
Oriental
3
   0.3%
0
   0.0%
3
   0.2%
Hispanic
10
   1.0%
12
   1.3%
22
   1.1%
Other
1
   0.1%
4
   0.4%
5
   0.3%
Karnofsky Performance Status (PS)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 974 participants 951 participants 1925 participants
PS 80
8
   0.8%
7
   0.7%
15
   0.8%
PS 90
91
   9.3%
81
   8.5%
172
   8.9%
PS 100
873
  89.6%
863
  90.7%
1736
  90.2%
Not done
2
   0.2%
0
   0.0%
2
   0.1%
[1]
Measure Description:

The Karnofsky PS Index classify patients as to their functional impairment. The lower the Karnofsky score, the worse the survival.

100 to 80: Able to carry on normal activity and to work; no special care needed.

70 to 50: Unable to work; able to live at home and care for most personal needs; varying amount of assistance needed.

40 to 0: Unable to care for self; requires equivalent of institutional or hospital care; disease may be progressing rapidly.

Menopausal status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 974 participants 951 participants 1925 participants
Premenopausal
472
  48.5%
482
  50.7%
954
  49.6%
Peri/postmenopausal
502
  51.5%
469
  49.3%
971
  50.4%
Tumor size   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 974 participants 951 participants 1925 participants
T1
557
  57.2%
569
  59.8%
1126
  58.5%
T2
403
  41.4%
369
  38.8%
772
  40.1%
T3
14
   1.4%
13
   1.4%
27
   1.4%
[1]
Measure Description:

Tumor (T) size describes the size of the tumour. Larger T is associated with inferior survival.

TX: can't be assessed. Tis: ductal carcinoma in situ. T1: tumour is 2 centimetres (cm) across or less. T1mi: tumour is 0.1cm across or less T1a: tumour >0.1 cm but <0.5 cm T1b: tumour >0.5 cm but <1 cm T1c: tumour >1 cm but <2 cm T2: tumour >2 cm but <5 cm across. T3: tumour >5 cm across. T4a: tumour has spread into the chest wall T4b: tumour has spread into the skin and the breast might be swollen T4c: tumour has spread to both the skin and the chest wall T4d: inflammatory carcinoma

Histologic type  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 974 participants 951 participants 1925 participants
Invasive Ductal Carcinoma
832
  85.4%
813
  85.5%
1645
  85.5%
Invasive Lobular Carcinoma
71
   7.3%
89
   9.4%
160
   8.3%
Other
71
   7.3%
49
   5.2%
120
   6.2%
Histologic grade   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 974 participants 951 participants 1925 participants
GX: Differenciation cannot be assessed
35
   3.6%
36
   3.8%
71
   3.7%
G1: Well differenciated
64
   6.6%
61
   6.4%
125
   6.5%
G2: Moderately differenciated
446
  45.8%
434
  45.6%
880
  45.7%
G3: Poorly differenciated
429
  44.0%
420
  44.2%
849
  44.1%
[1]
Measure Description:

Cancer cells are given a Grade (G) when they are removed from the breast and checked under a microscope. The G is based on how much the cancer cells look like normal cells.

G1 or well differentiated (score 3, 4, or 5): cells are slower-growing, and look more like normal breast tissue.

G2 or moderately differentiated (score 6, 7): cells are growing at a speed of and look like cells somewhere between G1 and 3.

G3 or poorly differentiated (score 8, 9): cells look very different from normal and will probably grow and spread faster.

Hormonal receptors  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 974 participants 951 participants 1925 participants
ER positive and/or PR positive
713
  73.2%
693
  72.9%
1406
  73.0%
ER negative and/or PR negative
261
  26.8%
258
  27.1%
519
  27.0%
Human Epidermal growth factor Receptor 2 (HER2) status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 974 participants 951 participants 1925 participants
HER2 positive
95
   9.8%
86
   9.0%
181
   9.4%
HER2 negative
858
  88.1%
846
  89.0%
1704
  88.5%
Unknown
21
   2.2%
19
   2.0%
40
   2.1%
Triple-negative disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 974 participants 951 participants 1925 participants
Triple-negative disease
218
  22.4%
224
  23.6%
442
  23.0%
Non triple-negative disease
735
  75.5%
708
  74.4%
1443
  75.0%
Unknown
21
   2.2%
19
   2.0%
40
   2.1%
Type of surgery  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 974 participants 951 participants 1925 participants
Mastectomy
261
  26.8%
265
  27.9%
526
  27.3%
Conservative
713
  73.2%
686
  72.1%
1399
  72.7%
Axillary surgery  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 974 participants 951 participants 1925 participants
Lymphadenectomy
559
  57.4%
551
  57.9%
1110
  57.7%
Sentinel node biopsy
402
  41.3%
384
  40.4%
786
  40.8%
Lymphadenectomy + Sentinel node biopsy
13
   1.3%
16
   1.7%
29
   1.5%
1.Primary Outcome
Title Disease-free Survival (DFS) Event
Hide Description DFS is defined as the evidence of local, regional or metastatic recurrence, second primary cancer (with the exception of carcinoma of squamous cells or basal cells of the skin, cervical carcinoma in situ or lobular or ductal carcinoma in situ of the breast) or death for any reason.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A: FAC Arm B: FAC-wP
Hide Arm/Group Description:
FAC X 6 The standard arm consisted of six cycles of FAC (fluorouracil 500 mg/m2, doxorubicin 50mg/m2, and cyclophosphamide 500mg/m2) administered once every 3 weeks.
FAC X 4 + 8 weekly Paclitaxel (wP) Patients in the experimental arm received four cycles of the FAC regimen followed by eight weekly administrations of paclitaxel (100mg/m2 per dose)
Overall Number of Participants Analyzed 974 951
Measure Type: Count of Participants
Unit of Measure: Participants
98
  10.1%
71
   7.5%
2.Secondary Outcome
Title Overall Survival (OS) Event
Hide Description OS event is defined as the death from any cause.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A: FAC Arm B: FAC-wP
Hide Arm/Group Description:
FAC X 6 The standard arm consisted of six cycles of FAC (fluorouracil 500 mg/m2, doxorubicin 50mg/m2, and cyclophosphamide 500mg/m2) administered once every 3 weeks.
FAC X 4 + 8 weekly Paclitaxel (wP) Patients in the experimental arm received four cycles of the FAC regimen followed by eight weekly administrations of paclitaxel (100mg/m2 per dose)
Overall Number of Participants Analyzed 974 951
Measure Type: Count of Participants
Unit of Measure: Participants
40
   4.1%
31
   3.3%
Time Frame Through study treatment up to 30 days after last study dose; All-Cause Mortality was assessed up to 5 years.
Adverse Event Reporting Description Only Adverse Events grade 3 and 4 were collected. All Serious Adverse Events (SAEs) grade 1, 2, 3, 4 and 5 were collected.
 
Arm/Group Title Arm A: FAC Arm B: FAC-wP
Hide Arm/Group Description FAC X 6 The standard arm consisted of six cycles of FAC (fluorouracil 500 mg/m2, doxorubicin 50mg/m2, and cyclophosphamide 500mg/m2) administered once every 3 weeks. FAC X 4 + 8 weekly Paclitaxel (wP) Patients in the experimental arm received four cycles of the FAC regimen followed by eight weekly administrations of paclitaxel (100mg/m2 per dose)
All-Cause Mortality
Arm A: FAC Arm B: FAC-wP
Affected / at Risk (%) Affected / at Risk (%)
Total   40/974 (4.11%)   31/951 (3.26%) 
Hide Serious Adverse Events
Arm A: FAC Arm B: FAC-wP
Affected / at Risk (%) Affected / at Risk (%)
Total   60/974 (6.16%)   61/951 (6.41%) 
Blood and lymphatic system disorders     
Febrile neutropenia * 1 [1]  31/974 (3.18%)  18/951 (1.89%) 
Neutropenia * 1 [2]  6/974 (0.62%)  1/951 (0.11%) 
Neutropenia * 1 [1]  3/974 (0.31%)  1/951 (0.11%) 
Neutropenia * 1 [3]  2/974 (0.21%)  1/951 (0.11%) 
Leukocytes * 1 [4]  1/974 (0.10%)  0/951 (0.00%) 
Hemoglobin * 1 [1]  0/974 (0.00%)  1/951 (0.11%) 
Cardiac disorders     
Thrombosis/embolism * 1 [1]  1/974 (0.10%)  3/951 (0.32%) 
Thrombosis/embolism * 1 [2]  0/974 (0.00%)  3/951 (0.32%) 
Cardiac-ischemia/infarction * 1 [2]  0/974 (0.00%)  1/951 (0.11%) 
Bradycardia and dyspnea * 1 [3]  0/974 (0.00%)  1/951 (0.11%) 
Gastrointestinal disorders     
Vomiting * 1 [1]  1/974 (0.10%)  2/951 (0.21%) 
Fistula-rectal/anal * 1 [2]  1/974 (0.10%)  0/951 (0.00%) 
Diarrhea * 1 [3]  0/974 (0.00%)  2/951 (0.21%) 
Constipation * 1 [1]  0/974 (0.00%)  1/951 (0.11%) 
Gastroenteritis * 1 [3]  0/974 (0.00%)  1/951 (0.11%) 
Vomiting * 1 [3]  0/974 (0.00%)  1/951 (0.11%) 
Gastrointestinal - appendicitis surgery * 1  0/974 (0.00%)  1/951 (0.11%) 
Stomatitis * 1 [3]  0/974 (0.00%)  1/951 (0.11%) 
General disorders     
Bone Fracture * 1 [1]  0/974 (0.00%)  1/951 (0.11%) 
Fever * 1 [5]  2/974 (0.21%)  2/951 (0.21%) 
Fatigue * 1 [3]  0/974 (0.00%)  2/951 (0.21%) 
Hepatobiliary disorders     
Hepatic - Hepatitis * 1 [1]  1/974 (0.10%)  0/951 (0.00%) 
SGOT (AST) and SGPT (ALT) * 1 [2]  0/974 (0.00%)  1/951 (0.11%) 
Infections and infestations     
Infection with grade 3 or 4 neutropenia * 1 [6]  5/974 (0.51%)  3/951 (0.32%) 
Infection without neutropenia * 1 [1]  2/974 (0.21%)  6/951 (0.63%) 
Wound-infectious * 1 [1]  1/974 (0.10%)  0/951 (0.00%) 
Septic shock * 1  0/974 (0.00%)  1/951 (0.11%) 
Investigations     
Hyperglycemia * 1 [1]  0/974 (0.00%)  1/951 (0.11%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletal - Right Essential Coxoartrosis * 1  0/974 (0.00%)  1/951 (0.11%) 
Nervous system disorders     
CNS cerebrovascular ischemia * 1 [2]  1/974 (0.10%)  0/951 (0.00%) 
Dizziness * 1 [3]  0/974 (0.00%)  1/951 (0.11%) 
Neurotoxicity * 1 [1]  0/974 (0.00%)  1/951 (0.11%) 
Respiratory, thoracic and mediastinal disorders     
Pneumonitis, refractory septic shock * 1 [2]  0/974 (0.00%)  1/951 (0.11%) 
Pneumonitis * 1 [1]  0/974 (0.00%)  1/951 (0.11%) 
Skin and subcutaneous tissue disorders     
Catheter-related infection * 1 [1]  1/974 (0.10%)  1/951 (0.11%) 
Injection site reaction * 1 [3]  1/974 (0.10%)  0/951 (0.00%) 
1
Term from vocabulary, NCI-CTCAE v. 2.0
*
Indicates events were collected by non-systematic assessment
[1]
Grade 3
[2]
Grade 4
[3]
Grade 2
[4]
Grade 4 and Fever grade 1
[5]
Grade 1
[6]
Grade 3 or 4
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm A: FAC Arm B: FAC-wP
Affected / at Risk (%) Affected / at Risk (%)
Total   442/974 (45.38%)   523/951 (54.99%) 
Blood and lymphatic system disorders     
Neutrophils/Granulocytes * 1 [1]  250/974 (25.67%)  203/951 (21.35%) 
Lymphopenia * 1 [1]  10/974 (1.03%)  8/951 (0.84%) 
Leukocytes * 1 [1]  93/974 (9.55%)  78/951 (8.20%) 
PLATELETS * 1 [1]  5/974 (0.51%)  3/951 (0.32%) 
HEMOGLOBIN * 1 [1]  4/974 (0.41%)  6/951 (0.63%) 
BILIRUBIN * 1 [1]  1/974 (0.10%)  1/951 (0.11%) 
Cardiac disorders     
Thrombosis/embolism * 1 [1]  1/974 (0.10%)  10/951 (1.05%) 
Cardiac Function * 1 [1]  0/974 (0.00%)  1/951 (0.11%) 
Cardiac Left Ventricular * 1 [1]  0/974 (0.00%)  1/951 (0.11%) 
Cardiac-ischemia/infarction * 1 [1]  1/974 (0.10%)  1/951 (0.11%) 
SYNCOPE (FAINTING) * 1 [1]  2/974 (0.21%)  1/951 (0.11%) 
VASOVAGAL EPISODE * 1 [1]  1/974 (0.10%)  3/951 (0.32%) 
Eye disorders     
CONJUNCTIVITIS * 1 [1]  5/974 (0.51%)  4/951 (0.42%) 
Gastrointestinal disorders     
Vomiting * 1 [1]  40/974 (4.11%)  40/951 (4.21%) 
Nausea * 1 [1]  25/974 (2.57%)  25/951 (2.63%) 
STOMATITIS/PHARYNGITIS (ORAL/PHARYNGEAL MUCOSITIS) * 1 [1]  17/974 (1.75%)  16/951 (1.68%) 
DIARRHEA * 1 [1]  3/974 (0.31%)  9/951 (0.95%) 
CONSTIPATION * 1 [1]  5/974 (0.51%)  6/951 (0.63%) 
MUCOSITIS * 1 [1]  4/974 (0.41%)  2/951 (0.21%) 
DYSPEPSIA/HEARTBURN * 1 [1]  3/974 (0.31%)  1/951 (0.11%) 
ANOREXIA * 1 [1]  0/974 (0.00%)  2/951 (0.21%) 
General disorders     
Febrile neutropenia * 1 [1]  36/974 (3.70%)  25/951 (2.63%) 
Fatigue * 1 [1]  34/974 (3.49%)  74/951 (7.78%) 
WEIGHT GAIN * 1 [1]  1/974 (0.10%)  6/951 (0.63%) 
WEIGHT LOSS * 1 [1]  2/974 (0.21%)  1/951 (0.11%) 
Hepatobiliary disorders     
GGT * 1 [1]  3/974 (0.31%)  5/951 (0.53%) 
SGOT (AST) * 1 [1]  4/974 (0.41%)  7/951 (0.74%) 
Immune system disorders     
ALLERGIC REACTION/HYPERSENSITIVITY * 1 [1]  0/974 (0.00%)  3/951 (0.32%) 
Infections and infestations     
Infection without neutropenia * 1 [1]  3/974 (0.31%)  13/951 (1.37%) 
Infection with unknown ANC * 1 [1]  3/974 (0.31%)  11/951 (1.16%) 
INFECTION WITH NEUTROPENIA * 1 [1]  9/974 (0.92%)  6/951 (0.63%) 
PNEUMONITIS/PULMONARY INFILTRATES * 1 [1]  0/974 (0.00%)  2/951 (0.21%) 
INFECTION * 1 [1]  1/974 (0.10%)  1/951 (0.11%) 
Investigations     
SGPT (ALT) * 1 [1]  10/974 (1.03%)  22/951 (2.31%) 
BONE PAIN * 1 [1]  2/974 (0.21%)  3/951 (0.32%) 
Metabolism and nutrition disorders     
HYPERGLYCEMIA * 1 [1]  4/974 (0.41%)  2/951 (0.21%) 
Musculoskeletal and connective tissue disorders     
ARTHRALGIA * 1 [1]  0/974 (0.00%)  9/951 (0.95%) 
Nervous system disorders     
Neurophaty-sensory * 1 [1]  0/974 (0.00%)  51/951 (5.36%) 
Myalgia * 1 [1]  2/974 (0.21%)  14/951 (1.47%) 
CNS cerebrovascular ischemia * 1 [1]  1/974 (0.10%)  0/951 (0.00%) 
MOOD ALTERATION-ANXIETY, AGITATION * 1 [1]  1/974 (0.10%)  4/951 (0.42%) 
Reproductive system and breast disorders     
Irregular Menses * 1 [1]  105/974 (10.78%)  148/951 (15.56%) 
HOT FLASHES/FLUSHES * 1 [1]  1/974 (0.10%)  1/951 (0.11%) 
Respiratory, thoracic and mediastinal disorders     
DYSPNEA * 1 [1]  0/974 (0.00%)  7/951 (0.74%) 
COUGH * 1 [1]  0/974 (0.00%)  2/951 (0.21%) 
PULMONARY * 1 [1]  0/974 (0.00%)  2/951 (0.21%) 
Skin and subcutaneous tissue disorders     
RASH/DESQUAMATION * 1 [1]  2/974 (0.21%)  9/951 (0.95%) 
NAIL CHANGES * 1 [1]  0/974 (0.00%)  5/951 (0.53%) 
HAND FOOT SKIN REACTION * 1 [1]  0/974 (0.00%)  5/951 (0.53%) 
PRURITUS * 1 [1]  0/974 (0.00%)  2/951 (0.21%) 
1
Term from vocabulary, NCI-CTCAE v. 2.0
*
Indicates events were collected by non-systematic assessment
[1]
Grade 3-4
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.
Results Point of Contact
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Name/Title: Scientific Director / Medical Lead / Project Manager
Organization: Spanish Breast Cancer Research Group
Phone: +34916592870
EMail: geicam@geicam.org
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Responsible Party: Spanish Breast Cancer Research Group
ClinicalTrials.gov Identifier: NCT00129389    
Other Study ID Numbers: GEICAM 2003-02
2005-003109-10 ( EudraCT Number )
First Submitted: August 10, 2005
First Posted: August 11, 2005
Results First Submitted: January 25, 2019
Results First Posted: July 12, 2019
Last Update Posted: July 12, 2019