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S0500 Treatment Decision Making Based on Blood Levels of Tumor Cells for Metastatic Breast Cancer Treated With Chemo

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ClinicalTrials.gov Identifier: NCT00382018
Recruitment Status : Completed
First Posted : September 28, 2006
Results First Posted : April 4, 2017
Last Update Posted : November 6, 2017
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Cancer and Leukemia Group B
Information provided by (Responsible Party):
Southwest Oncology Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Breast Cancer
Intervention Drug: chemotherapy
Enrollment 624
Recruitment Details  
Pre-assignment Details 624 patients were registered for screening. 29 patients were excluded due to initial CTC test not completed(17) and ineligible(12). 276 did not have increased CTC levels (Arm A). 319 patients had increased CTC levels. Additional 31 patients were excluded from 319 due to no CTC values on Day 21. Thus total 288 patients in ArmB, ArmC2 and ArmC2.
Arm/Group Title Arm A (Baseline CTCs < 5, Low Risk) Arm B (Baseline CTCs >= 5, Day 22 CTCs < 5, Moderate Risk) Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)
Hide Arm/Group Description Patients did not have increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB). Patients would be treated at clinician's discretion. Patients could be enrolled in other trials while being followed. Patients were followed only for overall survival (OS) and progression-free survival (PFS). Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) but < 5 CTCs at first follow-up (Day 22). Patients would maintain current therapy and will not be randomized. Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) and >= 5 CTCs at first follow-up (Day 22). Patients would be randomized to maintain current therapy. Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5mL WB) and >= 5CTCs at first follow-up (Day22). Patients would be randomized to change therapy to a different drug or combination of drugs.
Period Title: Overall Study
Started [1] 276 165 64 59
Completed 276 [2] 0 0 0
Not Completed 0 165 64 59
Reason Not Completed
Progression             0             136             51             43
Death             0             9             7             11
Withdrawal by Subject             0             4             3             4
Other, not protocol specified             0             16             3             1
[1]
Patients in this group were only followed for OS and PFS. Thus, no treatment status data.
[2]
This group of patients did not receive protocol treatment.
Arm/Group Title Arm A (Baseline CTCs < 5, Low Risk) Arm B (Baseline CTCs >= 5, Day 22 CTCs < 5, Moderate Risk) Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) Total
Hide Arm/Group Description Patients did not have increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB). Patients would be treated at clinician's discretion. Patients could be enrolled in other trials while being followed. Patients were followed only for overall survival (OS) and progression-free survival (PFS). Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) but < 5 CTCs at first follow-up (Day 22). Patients would maintain current therapy and will not be randomized. Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) and >= 5 CTCs at first follow-up (Day 22). Patients would be randomized to maintain current therapy. Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5mL WB) and >= 5CTCs at first follow-up (Day22). Patients would be randomized to change therapy to a different drug or combination of drugs. Total of all reporting groups
Overall Number of Baseline Participants 276 165 64 59 564
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Age 55 years or older Number Analyzed 276 participants 165 participants 64 participants 59 participants 564 participants
163
  59.1%
94
  57.0%
38
  59.4%
39
  66.1%
334
  59.2%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 276 participants 165 participants 64 participants 59 participants 564 participants
Female
276
 100.0%
165
 100.0%
64
 100.0%
59
 100.0%
564
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black Race  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 276 participants 165 participants 64 participants 59 participants 564 participants
50
  18.1%
23
  13.9%
15
  23.4%
7
  11.9%
95
  16.8%
Measurable disease   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 276 participants 165 participants 64 participants 59 participants 564 participants
221
  80.1%
137
  83.0%
47
  73.4%
50
  84.7%
455
  80.7%
[1]
Measure Description: Measurable disease: Lesions that can be accurately measured in at least one dimension by 1) medical photograph (skin or oral lesion), palpation, plain x-ray, CT, MRI or other conventional technique with longest diameter 2 cm or greater in the axial plane (bone lesions not included), or 2) spiral CT with longest diameter 1 cm or greater. Ultrasound is suitable only for superficial disease (superficial palpable nodes, subcutaneous lesions, thyroid nodules).
No. of patients classified by disease subtype  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 276 participants 165 participants 64 participants 59 participants 564 participants
275
  99.6%
162
  98.2%
64
 100.0%
59
 100.0%
560
  99.3%
Homo receptor positive, HER2 negative   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 275 participants 162 participants 64 participants 59 participants 560 participants
148
  53.8%
93
  57.4%
50
  78.1%
39
  66.1%
330
  58.9%
[1]
Measure Analysis Population Description: Only patients classified by disease subtype category will be included in the analysis.
Triple negative   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 275 participants 162 participants 64 participants 59 participants 560 participants
74
  26.9%
33
  20.4%
11
  17.2%
16
  27.1%
134
  23.9%
[1]
Measure Analysis Population Description: Only patients classified by disease subtype category will be included in the analysis.
HER2 positive   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 275 participants 162 participants 64 participants 59 participants 560 participants
53
  19.3%
36
  22.2%
3
   4.7%
4
   6.8%
96
  17.1%
[1]
Measure Analysis Population Description: Only patients classified by disease subtype category will be included in the analysis.
1.Primary Outcome
Title Overall Survival
Hide Description From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Time Frame Every 3 months until progression then every 6 months for 5 years or until death
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)
Hide Arm/Group Description:
Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) and >= 5 CTCs at first follow-up (Day 22). Patients would be randomized to maintain current therapy.
Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5mL WB) and >= 5CTCs at first follow-up (Day22). Patients would be randomized to change therapy to a different drug or combination of drugs.
Overall Number of Participants Analyzed 64 59
Median (95% Confidence Interval)
Unit of Measure: months
10.7
(9.1 to 14.8)
12.5
(8.4 to 16.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk), Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)
Comments Hazard Ration of overall survival compared Arm C2 to Arm C1.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.98
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
0.69 to 1.47
Estimation Comments [Not Specified]
2.Primary Outcome
Title Progression-free Survival
Hide Description Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Time Frame every 3 months until progression. From date of registration to date of first documentation of progressive disease, death due to any cause or symptomatic deterioration, whichever occurs first, assessed up to five years.
Hide Outcome Measure Data
Hide Analysis Population Description
Three patients in Arm C2 were judged as progression on day 22 and were excluded from the PFS analysis but were included in the OS analysis.
Arm/Group Title Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)
Hide Arm/Group Description:
Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) and >= 5 CTCs at first follow-up (Day 22). Patients would be randomized to maintain current therapy.
Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5mL WB) and >= 5CTCs at first follow-up (Day22). Patients would be randomized to change therapy to a different drug or combination of drugs.
Overall Number of Participants Analyzed 64 56
Median (95% Confidence Interval)
Unit of Measure: months
3.5
(2.1 to 4.7)
4.6
(3.1 to 6.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk), Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)
Comments Hazard Ratio of progression free survival compared Arm C2 to Arm C1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.64
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.64 to 1.32
Estimation Comments [Not Specified]
3.Primary Outcome
Title Overall Survival
Hide Description From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Time Frame Every 3 months until progression then every 6 months for 5 years or until death
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A (Baseline CTCs < 5, Low Risk) Arm B (Baseline CTCs >= 5, Day 22 CTCs < 5, Moderate Risk) Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)
Hide Arm/Group Description:
Patients did not have increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB). Patients would be treated at clinician's discretion. Patients could be enrolled in other trials while being followed. Patients were followed only for overall survival (OS) and progression-free survival (PFS).
Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) but < 5 CTCs at first follow-up (Day 22). Patients would maintain current therapy and will not be randomized.
Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) and >= 5 CTCs at first follow-up (Day 22). Patients would be randomized to maintain current therapy or change therapy to an alternative therapy
Overall Number of Participants Analyzed 276 165 123
Median (95% Confidence Interval)
Unit of Measure: months
35
(29 to 38.5)
23
(19 to 28.3)
13
(10.2 to 15.0)
4.Primary Outcome
Title Progression Free Survival
Hide Description From date of registration to date of first documentation of progressive disease, death due to any cause or symptomatic deterioration, whichever occurs first. Patients last known to be alive and progression-free are censored at date of last contact.
Time Frame every 3 months until progression
Hide Outcome Measure Data
Hide Analysis Population Description
Three patients in Arm C were judged as progressing on day 22 and were excluded from the PFS analysis but were included in the OS analysis.
Arm/Group Title Arm A (Baseline CTCs < 5, Low Risk) Arm B (Baseline CTCs >= 5, Day 22 CTCs < 5, Moderate Risk) Arm C (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)
Hide Arm/Group Description:
Patients did not have increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB). Patients would be treated at clinician's discretion. Patients could be enrolled in other trials while being followed. Patients were followed only for overall survival (OS) and progression-free survival (PFS).
Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) but < 5 CTCs at first follow-up (Day 22). Patients would maintain current therapy and will not be randomized.
Patients had increased CTCs at baseline (defined as five or more CTCs per 7.5 mL WB) and >= 5 CTCs at first follow-up (Day 22). Patients would be randomized to maintain current therapy or change therapy to an alternative therapy
Overall Number of Participants Analyzed 276 165 120
Median (95% Confidence Interval)
Unit of Measure: months
11.1
(9.5 to 12.5)
8.9
(8.1 to 10.8)
4.9
(3.8 to 5.7)
5.Secondary Outcome
Title Number of Patients With Adverse Events That Are Related to Study Drugs
Hide Description Adverse Events (AEs) are reported by CTCAE Version 3.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.
Time Frame Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Hide Outcome Measure Data
Hide Analysis Population Description
Patients in 'Arm A (Baseline CTCs < 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. And only patients who were evaluable for Adverse Event Assessment were included in the following analysis results.
Arm/Group Title Arm B (Baseline CTCs >= 5, Day 22 CTCs < 5, Moderate Risk) Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 161 64 56
Measure Type: Number
Unit of Measure: Participants
ALT, SGPT (serum glutamic pyruvic transaminase) 8 1 3
AST, SGOT 10 1 6
Albumin, serum-low (hypoalbuminemia) 5 2 4
Alkaline phosphatase 7 5 8
Allergic reaction/hypersensitivity 3 1 1
Allergic rhinitis 2 1 1
Allergy/Immunology-Other (Specify) 1 0 1
Anorexia 16 5 9
Ascites (non-malignant) 0 1 1
Auditory/Ear-Other (Specify) 0 1 0
Bilirubin (hyperbilirubinemia) 5 2 3
Blood/Bone Marrow-Other (Specify) 1 1 0
CNS cerebrovascular ischemia 1 0 0
Calcium, serum-high (hypercalcemia) 2 1 0
Calcium, serum-low (hypocalcemia) 5 3 4
Confusion 2 0 1
Constipation 12 5 6
Constitutional Symptoms-Other (Specify) 1 0 0
Cough 3 0 0
Creatinine 15 5 2
Dehydration 17 6 7
Dermatology/Skin-Other (Specify) 2 1 2
Diarrhea 55 10 15
Distention/bloating, abdominal 0 1 0
Dizziness 2 2 1
Dry eye syndrome 0 0 1
Dry mouth/salivary gland (xerostomia) 1 0 1
Dry skin 5 1 1
Dyspnea (shortness of breath) 18 9 9
Edema: head and neck 2 0 0
Edema: limb 3 0 6
Fatigue (asthenia, lethargy, malaise) 103 36 36
Febrile neutropenia 6 0 2
Fever in absence of neutropenia, ANC lt1.0x10e9/L 3 3 1
Flatulence 1 0 0
Flushing 2 0 0
Gastrointestinal-Other (Specify) 1 0 0
Glucose, serum-high (hyperglycemia) 13 4 7
Glucose, serum-low (hypoglycemia) 0 0 1
Hair loss/Alopecia (scalp or body) 20 5 5
Heartburn/dyspepsia 2 1 0
Hemoglobin 100 32 38
Hemorrhage, Respiratory tract NOS 1 0 0
Hemorrhage, GI - Stomach 1 0 0
Hemorrhage, GU - Uterus 1 0 0
Hemorrhage, pulmonary/upper respiratory - Nose 7 4 0
Hot flashes/flushes 3 1 4
Hyperpigmentation 1 3 0
Hypertension 6 0 2
Hypotension 3 1 1
Ileus, GI (functional obstruction of bowel) 0 1 0
Induration/fibrosis (skin and subcutaneous tissue) 1 0 0
Inf (clin/microbio) w/Gr 3-4 neuts - Blood 1 1 0
Inf (clin/microbio) w/Gr 3-4 neuts - Skin 0 0 1
Inf (clin/microbio) w/Gr 3-4 neuts - UTI 1 0 0
Inf w/normal ANC or Gr 1-2 neutrophils - Lung 1 0 0
Inf w/normal ANC or Gr 1-2 neutrophils - Nose 1 0 0
Inf w/normal ANC or Gr 1-2 neutrophils - Oral cav 0 1 1
Inf w/normal ANC or Gr 1-2 neutrophils - Sinus 3 0 0
Inf w/normal ANC or Gr 1-2 neutrophils - Skin 0 0 2
Inf w/normal ANC or Gr 1-2 neutrophils - UTI 3 0 1
Inf w/normal ANC or Gr 1-2 neutrophils - Up airway 1 0 0
Infection with unknown ANC - Sinus 1 0 0
Infection with unknown ANC - Skin (cellulitis) 2 0 0
Infection with unknown ANC - Urinary tract NOS 0 2 0
Infection-Other (Specify) 2 0 0
Injection site reaction/extravasation changes 0 0 1
Insomnia 2 1 1
Left ventricular systolic dysfunction 1 0 1
Leukocytes (total WBC) 28 11 10
Lymphopenia 8 2 3
Magnesium, serum-low (hypomagnesemia) 2 0 1
Memory impairment 0 1 0
Metabolic/Laboratory-Other (Specify) 1 1 0
Mood alteration - anxiety 2 0 1
Mood alteration - depression 3 1 1
Mucositis/stomatitis (clinical exam) - Oral cavity 10 0 2
Mucositis/stomatitis (functional/symp) - Oral cav 2 2 1
Muscle weakness, not d/t neuropathy - Extrem-lower 2 0 0
Muscle weakness, not d/t neuropathy - Extrem-upper 1 0 0
Muscle weakness, not d/t neuropathy - body/general 1 1 5
Musculoskeletal/Soft Tissue-Other (Specify) 1 1 0
Nail changes 2 1 3
Nasal cavity/paranasal sinus reactions 1 0 0
Nausea 27 10 10
Neuropathy: motor 1 0 0
Neuropathy: sensory 23 3 5
Neutrophils/granulocytes (ANC/AGC) 71 23 25
Ocular/Visual-Other (Specify) 0 0 1
Osteonecrosis (avascular necrosis) 0 0 1
Pain - Abdomen NOS 0 2 1
Pain - Back 6 1 3
Pain - Bladder 1 0 0
Pain - Bone 27 8 9
Pain - Breast 0 1 0
Pain - Chest wall 1 0 0
Pain - Chest/thorax NOS 3 0 1
Pain - Extremity-limb 0 0 2
Pain - Face 1 0 0
Pain - Head/headache 5 2 1
Pain - Joint 8 1 4
Pain - Muscle 10 0 2
Pain - Neck 0 0 1
Pain - Neuralgia/peripheral nerve 1 0 0
Pain - Oral cavity 1 0 0
Pain - Oral-gums 0 0 1
Pain - Pain NOS 2 0 1
Pain - Pelvis 1 0 0
Pain - Rectum 1 0 0
Pain - Scalp 0 1 0
Pain - Stomach 0 1 1
Pain - Throat/pharynx/larynx 1 0 0
Pain - Vagina 1 0 0
Pain-Other (Specify) 0 3 1
Phosphate, serum-low (hypophosphatemia) 1 1 2
Platelets 42 16 23
Pleural effusion (non-malignant) 0 0 1
Pneumonitis/pulmonary infiltrates 2 0 0
Potassium, serum-high (hyperkalemia) 1 0 0
Potassium, serum-low (hypokalemia) 4 1 1
Proteinuria 2 0 0
Pruritus/itching 2 0 0
Pulmonary/Upper Respiratory-Other (Specify) 1 0 0
Rash/desquamation 2 0 2
Rash: acne/acneiform 2 2 0
Rash: hand-foot skin reaction 10 4 3
Renal/Genitourinary-Other (Specify) 1 0 0
Restrictive cardiomyopathy 2 0 0
Retinopathy 0 0 1
Rigors/chills 1 1 0
SVT and nodal arrhythmia - Atrial tachycardia/PAT 1 0 0
SVT and nodal arrhythmia - Sinus tachycardia 3 0 0
Sodium, serum-high (hypernatremia) 1 0 1
Sodium, serum-low (hyponatremia) 6 0 2
Sweating (diaphoresis) 1 0 1
Syndromes-Other (Specify) 0 0 1
Taste alteration (dysgeusia) 6 2 2
Thrombosis/thrombus/embolism 5 1 2
Thyroid function, high 0 1 0
Triglyceride, serum-high (hypertriglyceridemia) 0 1 0
Urinary frequency/urgency 1 0 0
Vaginal dryness 0 1 0
Vision-blurred vision 1 1 0
Vomiting 38 10 14
Watery eye (epiphora, tearing) 1 1 0
Weight loss 8 2 3
6.Other Pre-specified Outcome
Title Correlation of CTC Levels With Breast Cancer Tumor Markers
Hide Description [Not Specified]
Time Frame Baseline, Weeks 4, 8, 13, 25, 37 and at progression
Outcome Measure Data Not Reported
Time Frame Toxicity assessment was evaluated after 3 weeks, 6 weeks, and every 6 weeks thereafter until progression
Adverse Event Reporting Description Patients in 'Arm A (Baseline CTCs < 5, Low Risk)' were followed only for overall survival (OS) and progression-free survival (PFS). Adverse events were not collected/assessed in these patients. Only patients who were evaluable for Adverse Event Assessment were included in the analysis result.
 
Arm/Group Title Arm B (Baseline CTCs >= 5, Day 22 CTCs < 5, Moderate Risk) Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
Arm B (Baseline CTCs >= 5, Day 22 CTCs < 5, Moderate Risk) Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Arm B (Baseline CTCs >= 5, Day 22 CTCs < 5, Moderate Risk) Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/161 (0.00%)   1/64 (1.56%)   0/56 (0.00%) 
Gastrointestinal disorders       
Gastrointestinal-Other  1  0/161 (0.00%)  1/64 (1.56%)  0/56 (0.00%) 
Metabolism and nutrition disorders       
Dehydration  1  0/161 (0.00%)  1/64 (1.56%)  0/56 (0.00%) 
Renal and urinary disorders       
Renal/Genitourinary-Other  1  0/161 (0.00%)  1/64 (1.56%)  0/56 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm B (Baseline CTCs >= 5, Day 22 CTCs < 5, Moderate Risk) Arm C1 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk) Arm C2 (Baseline CTCs >= 5, Day 22 CTCs >= 5, High Risk)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   152/161 (94.41%)   57/64 (89.06%)   53/56 (94.64%) 
Blood and lymphatic system disorders       
Hemoglobin  1  112/161 (69.57%)  35/64 (54.69%)  43/56 (76.79%) 
Gastrointestinal disorders       
Constipation  1  20/161 (12.42%)  8/64 (12.50%)  8/56 (14.29%) 
Diarrhea  1  66/161 (40.99%)  15/64 (23.44%)  16/56 (28.57%) 
Mucositis/stomatitis (clinical exam) - Oral cavity  1  11/161 (6.83%)  0/64 (0.00%)  2/56 (3.57%) 
Nausea  1  30/161 (18.63%)  10/64 (15.63%)  11/56 (19.64%) 
Pain - Abdomen NOS  1  4/161 (2.48%)  5/64 (7.81%)  2/56 (3.57%) 
Vomiting  1  52/161 (32.30%)  17/64 (26.56%)  17/56 (30.36%) 
General disorders       
Edema: limb  1  15/161 (9.32%)  2/64 (3.13%)  8/56 (14.29%) 
Fatigue (asthenia, lethargy, malaise)  1  112/161 (69.57%)  40/64 (62.50%)  42/56 (75.00%) 
Fever in absence of neutropenia, ANC lt1.0x10e9/L  1  7/161 (4.35%)  4/64 (6.25%)  2/56 (3.57%) 
Pain - Pain NOS  1  3/161 (1.86%)  1/64 (1.56%)  3/56 (5.36%) 
Pain-Other  1  5/161 (3.11%)  4/64 (6.25%)  4/56 (7.14%) 
Infections and infestations       
Inf w/normal ANC or Gr 1-2 neutrophils - Skin  1  2/161 (1.24%)  1/64 (1.56%)  3/56 (5.36%) 
Investigations       
ALT, SGPT (serum glutamic pyruvic transaminase)  1  13/161 (8.07%)  5/64 (7.81%)  3/56 (5.36%) 
AST, SGOT  1  17/161 (10.56%)  5/64 (7.81%)  10/56 (17.86%) 
Alkaline phosphatase  1  14/161 (8.70%)  7/64 (10.94%)  10/56 (17.86%) 
Bilirubin (hyperbilirubinemia)  1  11/161 (6.83%)  3/64 (4.69%)  7/56 (12.50%) 
Creatinine  1  24/161 (14.91%)  8/64 (12.50%)  7/56 (12.50%) 
Leukocytes (total WBC)  1  29/161 (18.01%)  11/64 (17.19%)  10/56 (17.86%) 
Lymphopenia  1  9/161 (5.59%)  2/64 (3.13%)  3/56 (5.36%) 
Metabolic/Laboratory-Other  1  3/161 (1.86%)  1/64 (1.56%)  3/56 (5.36%) 
Neutrophils/granulocytes (ANC/AGC)  1  77/161 (47.83%)  24/64 (37.50%)  28/56 (50.00%) 
Platelets  1  49/161 (30.43%)  19/64 (29.69%)  25/56 (44.64%) 
Weight loss  1  10/161 (6.21%)  4/64 (6.25%)  3/56 (5.36%) 
Metabolism and nutrition disorders       
Albumin, serum-low (hypoalbuminemia)  1  8/161 (4.97%)  3/64 (4.69%)  6/56 (10.71%) 
Anorexia  1  19/161 (11.80%)  5/64 (7.81%)  11/56 (19.64%) 
Calcium, serum-high (hypercalcemia)  1  4/161 (2.48%)  1/64 (1.56%)  3/56 (5.36%) 
Calcium, serum-low (hypocalcemia)  1  9/161 (5.59%)  4/64 (6.25%)  7/56 (12.50%) 
Dehydration  1  27/161 (16.77%)  8/64 (12.50%)  10/56 (17.86%) 
Glucose, serum-high (hyperglycemia)  1  22/161 (13.66%)  7/64 (10.94%)  7/56 (12.50%) 
Potassium, serum-low (hypokalemia)  1  6/161 (3.73%)  4/64 (6.25%)  4/56 (7.14%) 
Sodium, serum-low (hyponatremia)  1  8/161 (4.97%)  1/64 (1.56%)  4/56 (7.14%) 
Musculoskeletal and connective tissue disorders       
Muscle weakness, not d/t neuropathy - body/general  1  2/161 (1.24%)  1/64 (1.56%)  6/56 (10.71%) 
Pain - Back  1  20/161 (12.42%)  4/64 (6.25%)  6/56 (10.71%) 
Pain - Bone  1  64/161 (39.75%)  21/64 (32.81%)  20/56 (35.71%) 
Pain - Extremity-limb  1  7/161 (4.35%)  1/64 (1.56%)  3/56 (5.36%) 
Pain - Joint  1  18/161 (11.18%)  4/64 (6.25%)  7/56 (12.50%) 
Pain - Muscle  1  14/161 (8.70%)  3/64 (4.69%)  3/56 (5.36%) 
Nervous system disorders       
Dizziness  1  6/161 (3.73%)  2/64 (3.13%)  3/56 (5.36%) 
Neuropathy: sensory  1  28/161 (17.39%)  4/64 (6.25%)  7/56 (12.50%) 
Pain - Head/headache  1  8/161 (4.97%)  5/64 (7.81%)  5/56 (8.93%) 
Psychiatric disorders       
Mood alteration - anxiety  1  4/161 (2.48%)  2/64 (3.13%)  3/56 (5.36%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  14/161 (8.70%)  5/64 (7.81%)  4/56 (7.14%) 
Dyspnea (shortness of breath)  1  53/161 (32.92%)  18/64 (28.13%)  20/56 (35.71%) 
Hemorrhage, pulmonary/upper respiratory - Nose  1  7/161 (4.35%)  4/64 (6.25%)  0/56 (0.00%) 
Pleural effusion (non-malignant)  1  0/161 (0.00%)  0/64 (0.00%)  3/56 (5.36%) 
Skin and subcutaneous tissue disorders       
Hair loss/Alopecia (scalp or body)  1  20/161 (12.42%)  5/64 (7.81%)  6/56 (10.71%) 
Nail changes  1  2/161 (1.24%)  1/64 (1.56%)  4/56 (7.14%) 
Rash/desquamation  1  4/161 (2.48%)  0/64 (0.00%)  3/56 (5.36%) 
Rash: hand-foot skin reaction  1  10/161 (6.21%)  4/64 (6.25%)  3/56 (5.36%) 
Vascular disorders       
Hot flashes/flushes  1  4/161 (2.48%)  1/64 (1.56%)  4/56 (7.14%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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
Layout table for Results Point of Contact information
Name/Title: Breast Committee Statistician
Organization: SWOG
Phone: 2066675712
EMail: jmiao@fredhutch.org
Layout table for additonal information
Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00382018    
Other Study ID Numbers: CDR0000504319
S0500 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Submitted: September 26, 2006
First Posted: September 28, 2006
Results First Submitted: December 16, 2016
Results First Posted: April 4, 2017
Last Update Posted: November 6, 2017