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S0226 Anastrozole With or Without Fulvestrant as First-Line Therapy in Postmenopausal Women With Metastatic Breast Cancer

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: NCT00075764
Recruitment Status : Completed
First Posted : January 13, 2004
Results First Posted : April 4, 2017
Last Update Posted : January 13, 2021
Sponsor:
Collaborators:
National Cancer Institute (NCI)
NCIC Clinical Trials Group
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: Treatment
Condition Breast Cancer
Interventions Drug: anastrozole
Drug: fulvestrant
Enrollment 695
Recruitment Details

707 Patients underwent randomization. 12 were excluded: 9 did not have metastatic disease, 1 had previous chemotherapy, 1 was estrogen-receptor and progesterone-receptor negative, 1 did not undergo chest imaging. In addition, 1 patient withdrew consent.

694 patients were included in the analysis.

Pre-assignment Details  
Arm/Group Title Arm I Anastrozole Arm II Anastrozole and Fulvestrant
Hide Arm/Group Description

Patients receive oral anastrozole once daily on days 1-28.

anastrozole: Given orally

Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1, 14, and 28 during course 1 and then on day 28 of the subsequent courses.

anastrozole: Given orally

fulvestrant: Given intramuscularly

Period Title: Overall Study
Started 345 349
Completed 0 0
Not Completed 345 349
Reason Not Completed
Adverse Event             5             12
Death             4             8
Withdrawal by Subject             28             18
Progression             269             274
Still on treatment             8             15
Delinquent             4             2
Not protocol specified             27             19
Under review             0             1
Arm/Group Title Arm I Anastrozole Arm II Anastrozole and Fulvestrant Total
Hide Arm/Group Description

Patients receive oral anastrozole once daily on days 1-28.

anastrozole: Given orally

Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1, 14, and 28 during course 1 and then on day 28 of the subsequent courses.

anastrozole: Given orally

fulvestrant: Given intramuscularly

Total of all reporting groups
Overall Number of Baseline Participants 345 349 694
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 345 participants 349 participants 694 participants
65
(36 to 91)
65
(27 to 92)
65
(27 to 92)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 345 participants 349 participants 694 participants
Female
345
 100.0%
349
 100.0%
694
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Prior adjuvant tamoxifen  
Measure Type: Number
Unit of measure:  Participants
Yes Number Analyzed 345 participants 349 participants 694 participants
139 141 280
No Number Analyzed 345 participants 349 participants 694 participants
206 208 414
Prior adjuvant chemotherapy  
Measure Type: Number
Unit of measure:  Participants
Yes Number Analyzed 345 participants 349 participants 694 participants
103 129 232
No Number Analyzed 345 participants 349 participants 694 participants
242 220 462
Measurable disease  
Measure Type: Number
Unit of measure:  Participants
Yes Number Analyzed 345 participants 349 participants 694 participants
188 188 376
No Number Analyzed 345 participants 349 participants 694 participants
157 161 318
Disease site  
Measure Type: Number
Unit of measure:  Participants
Bone only Number Analyzed 345 participants 349 participants 694 participants
76 75 151
Visceral Number Analyzed 345 participants 349 participants 694 participants
167 181 348
Nonvisceral Number Analyzed 345 participants 349 participants 694 participants
102 93 195
Time between diagnosis of primary and metastatic disease   [1] 
Measure Type: Number
Unit of measure:  Participants
None Number Analyzed 337 participants 339 participants 676 participants
141 122 263
3 mo to < 5 yr Number Analyzed 337 participants 339 participants 676 participants
40 47 87
5 to < 10 yr Number Analyzed 337 participants 339 participants 676 participants
68 66 134
>= 10 yr Number Analyzed 337 participants 339 participants 676 participants
88 104 192
[1]
Measure Analysis Population Description: Only patients with non missing value of time between diagnosis of primary and metastatic disease will be included.
HER2 status   [1] [2] 
Measure Type: Number
Unit of measure:  Participants
Positive Number Analyzed 295 participants 297 participants 592 participants
25 31 56
Negative Number Analyzed 295 participants 297 participants 592 participants
270 266 536
[1]
Measure Description: HER2 denotes human epidermal growth factor receptor type 2.
[2]
Measure Analysis Population Description: Only patients with available HER2 status data will be included in the analysis.
1.Primary Outcome
Title Time to Tumor Progression
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 measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. Unequivocal progression of non-measurable disease in the opinion of the treating physician. Appearance of any new lesion/site. Death due to disease without prior documentation of progression and without symptomatic deterioration. From date of randomization to time of first documentation of progression, symptomatic deterioration or death due to any cause. Patients last known to be alive and progression free are considered at last date of contact.
Time Frame Every 4 weeks while on treatment. Then every 3 months until progression, then six months for two years then annually until four years or until death, which ever occurs first.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I Anastrozole Arm II Anastrozole and Fulvestrant
Hide Arm/Group Description:

Patients receive oral anastrozole once daily on days 1-28.

anastrozole: Given orally

Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1, 14, and 28 during course 1 and then on day 28 of the subsequent courses.

anastrozole: Given orally

fulvestrant: Given intramuscularly

Overall Number of Participants Analyzed 345 349
Median (95% Confidence Interval)
Unit of Measure: months
13.5
(12.1 to 15.1)
15.0
(13.2 to 18.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I Anastrozole, Arm II Anastrozole and Fulvestrant
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments [Not Specified]
Method Log Rank
Comments Two-sided stratified log-rank test
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.80
Confidence Interval (2-Sided) 95%
0.68 to 0.94
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Clinical Benefit (CR, PR, Confirmed or Unconfirmed, or Stable Disease >= 24 Weeks).
Hide Description Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable, Does not qualify for CR, PR, Progression or Symptomatic Deterioration. Clinical Benefit = CR + PR + Stable >= 24 weeks
Time Frame Every 4 weeks while on treatment. Then every 3 months until progression, then six months for two years then annually until four years or until death, which ever occurs first.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I Anastrozole Arm II Anastrozole and Fulvestrant
Hide Arm/Group Description:

Patients receive oral anastrozole once daily on days 1-28.

anastrozole: Given orally

Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1, 14, and 28 during course 1 and then on day 28 of the subsequent courses.

anastrozole: Given orally

fulvestrant: Given intramuscularly

Overall Number of Participants Analyzed 345 349
Measure Type: Number
Unit of Measure: percentage of participants
70 73
3.Secondary Outcome
Title Overall Survival
Hide Description From date of randomization to date of death due to any cause. Patients last known to be alive are censored at last date of contact.
Time Frame Every 4 weeks while on treatment. Then every 3 months until progression, then six months for two years then annually until four years or until death, which ever occurs first.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I Anastrozole Arm II Anastrozole and Fulvestrant
Hide Arm/Group Description:

Patients receive oral anastrozole once daily on days 1-28.

anastrozole: Given orally

Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1, 14, and 28 during course 1 and then on day 28 of the subsequent courses.

anastrozole: Given orally

fulvestrant: Given intramuscularly

Overall Number of Participants Analyzed 345 349
Median (95% Confidence Interval)
Unit of Measure: months
41.3
(37.2 to 45.0)
47.7
(43.4 to 55.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I Anastrozole, Arm II Anastrozole and Fulvestrant
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.049
Comments [Not Specified]
Method Log Rank
Comments A log-rank test, stratified according to prior or no prior tamoxifen therapy.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.81
Confidence Interval (2-Sided) 95%
0.65 to 1.00
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hide Description Adverse Events (AEs) are reported by CTCAE version 3.0 terminology. For each patient, worst grade of each event type is reported. Grade3 (Severe), Grade4 (Life-threatening), Grade 5 (Fatal)
Time Frame Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who had received the protocol treatments were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
Arm/Group Title Arm I Anastrozole Arm II Anastrozole and Fulvestrant
Hide Arm/Group Description:
Patients receive oral anastrozole once daily on days 1-28
Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1 , 14, and 28 during course 1 and then on day 28 of the subsequent courses.
Overall Number of Participants Analyzed 337 348
Measure Type: Number
Unit of Measure: Participants
ALT, SGPT (serum glutamic pyruvic transaminase) 1 1
AST, SGOT 3 1
Albumin, serum-low (hypoalbuminemia) 1 1
Alkaline phosphatase 1 0
Anorexia 0 1
Bilirubin (hyperbilirubinemia) 1 0
CNS cerebrovascular ischemia 0 2
Calcium, serum-high (hypercalcemia) 1 0
Cataract 1 1
Confusion 0 1
Constipation 1 1
Dehydration 1 1
Diarrhea 2 1
Dizziness 1 2
Dyspnea (shortness of breath) 1 1
Edema: limb 1 1
Fatigue (asthenia, lethargy, malaise) 7 9
Febrile neutropenia 1 0
Fracture 1 2
Glucose, serum-high (hyperglycemia) 1 2
Hemoglobin 1 3
Hemolysis 1 1
Hot flashes/flushes 2 7
Hypertension 2 1
Inf w/normal ANC or Gr 1-2 neutrophils - Blood 1 0
Inf w/normal ANC or Gr 1-2 neutrophils - UTI 1 1
Infection with unknown ANC - Urinary tract NOS 0 2
Insomnia 0 1
Joint-effusion 0 2
Leukocytes (total WBC) 0 1
Lymphopenia 3 3
Memory impairment 1 0
Mood alteration - agitation 0 1
Mood alteration - anxiety 1 0
Mood alteration - depression 0 3
Mucositis/stomatitis (functional/symp) - Pharynx 1 0
Muscle weakness, not d/t neuropathy - body/general 1 0
Nausea 3 1
Neurology-Other (Specify) 1 0
Neuropathy: sensory 1 0
Neutrophils/granulocytes (ANC/AGC) 0 2
Pain - Abdomen NOS 1 2
Pain - Back 5 7
Pain - Bone 1 1
Pain - Breast 1 0
Pain - Buttock 1 0
Pain - Chest wall 0 1
Pain - Chest/thorax NOS 1 1
Pain - Extremity-limb 0 3
Pain - Head/headache 1 0
Pain - Joint 5 7
Pain - Muscle 3 0
Pain - Neck 0 1
Pain - Pelvis 0 3
Pain-Other (Specify) 2 1
Platelets 2 2
Rash/desquamation 1 1
Sodium, serum-low (hyponatremia) 0 1
Speech impairment (e.g., dysphasia or aphasia) 1 0
Sudden death 0 1
Syncope (fainting) 0 1
Thrombosis/embolism (vascular access-related) 3 1
Thrombosis/thrombus/embolism 6 7
Tinnitus 0 1
Tumor flare 0 2
Urticaria (hives, welts, wheals) 0 1
Vomiting 3 2
Weight gain 0 1
Time Frame Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Adverse Event Reporting Description Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
 
Arm/Group Title Anastrozole Anastrozole & Fulvestrant
Hide Arm/Group Description Patients receive oral anastrozole once daily on days 1-28 Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1 , 14, and 28 during course 1 and then on day 28 of the subsequent courses.
All-Cause Mortality
Anastrozole Anastrozole & Fulvestrant
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Anastrozole Anastrozole & Fulvestrant
Affected / at Risk (%) Affected / at Risk (%)
Total   21/337 (6.23%)   48/348 (13.79%) 
Blood and lymphatic system disorders     
Blood/Bone Marrow-Other  1  0/337 (0.00%)  1/348 (0.29%) 
Febrile neutropenia  1  0/337 (0.00%)  1/348 (0.29%) 
Hemoglobin  1  2/337 (0.59%)  1/348 (0.29%) 
Cardiac disorders     
Atrioventricular block - 2nd degree Mobitz Type II  1  0/337 (0.00%)  1/348 (0.29%) 
Cardiac-ischemia/infarction  1  1/337 (0.30%)  2/348 (0.57%) 
Left ventricular diastolic dysfunction  1  0/337 (0.00%)  1/348 (0.29%) 
Left ventricular systolic dysfunction  1  1/337 (0.30%)  0/348 (0.00%) 
Restrictive cardiomyopathy  1  1/337 (0.30%)  0/348 (0.00%) 
Eye disorders     
Dry eye syndrome  1  0/337 (0.00%)  1/348 (0.29%) 
Gastrointestinal disorders     
Constipation  1  0/337 (0.00%)  3/348 (0.86%) 
Diarrhea  1  1/337 (0.30%)  1/348 (0.29%) 
Ileus, GI (functional obstruction of bowel)  1  0/337 (0.00%)  2/348 (0.57%) 
Nausea  1  0/337 (0.00%)  1/348 (0.29%) 
Obstruction, GI - Ileum  1  0/337 (0.00%)  1/348 (0.29%) 
Obstruction, GI - Small bowel NOS  1  0/337 (0.00%)  1/348 (0.29%) 
Pain - Abdomen NOS  1  0/337 (0.00%)  2/348 (0.57%) 
Perforation, GI - Colon  1  0/337 (0.00%)  2/348 (0.57%) 
Vomiting  1  2/337 (0.59%)  1/348 (0.29%) 
General disorders     
Death not associated with CTCAE term - Death NOS  1  1/337 (0.30%)  1/348 (0.29%) 
Fatigue (asthenia, lethargy, malaise)  1  0/337 (0.00%)  1/348 (0.29%) 
Pain - Chest/thorax NOS  1  0/337 (0.00%)  1/348 (0.29%) 
Pain-Other  1  0/337 (0.00%)  1/348 (0.29%) 
Sudden death  1  0/337 (0.00%)  2/348 (0.57%) 
Infections and infestations     
Colitis, infectious (e.g., Clostridium difficile)  1  0/337 (0.00%)  1/348 (0.29%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Blood  1  0/337 (0.00%)  1/348 (0.29%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Bone  1  0/337 (0.00%)  1/348 (0.29%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Lung  1  1/337 (0.30%)  2/348 (0.57%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Pleura  1  0/337 (0.00%)  1/348 (0.29%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Skin  1  0/337 (0.00%)  1/348 (0.29%) 
Inf w/normal ANC or Gr 1-2 neutrophils - UTI  1  0/337 (0.00%)  3/348 (0.86%) 
Infection with unknown ANC - Lung (pneumonia)  1  0/337 (0.00%)  1/348 (0.29%) 
Infection with unknown ANC - Rectum  1  0/337 (0.00%)  1/348 (0.29%) 
Infection with unknown ANC - Urinary tract NOS  1  0/337 (0.00%)  3/348 (0.86%) 
Injury, poisoning and procedural complications     
Fracture  1  0/337 (0.00%)  5/348 (1.44%) 
Investigations     
Leukocytes (total WBC)  1  1/337 (0.30%)  0/348 (0.00%) 
Neutrophils/granulocytes (ANC/AGC)  1  1/337 (0.30%)  1/348 (0.29%) 
Platelets  1  0/337 (0.00%)  1/348 (0.29%) 
Metabolism and nutrition disorders     
Anorexia  1  0/337 (0.00%)  2/348 (0.57%) 
Calcium, serum-low (hypocalcemia)  1  0/337 (0.00%)  1/348 (0.29%) 
Dehydration  1  0/337 (0.00%)  6/348 (1.72%) 
Glucose, serum-high (hyperglycemia)  1  0/337 (0.00%)  4/348 (1.15%) 
Potassium, serum-low (hypokalemia)  1  0/337 (0.00%)  2/348 (0.57%) 
Sodium, serum-low (hyponatremia)  1  0/337 (0.00%)  2/348 (0.57%) 
Musculoskeletal and connective tissue disorders     
Arthritis (non-septic)  1  0/337 (0.00%)  1/348 (0.29%) 
Joint-effusion  1  0/337 (0.00%)  1/348 (0.29%) 
Muscle weakness, not d/t neuropathy - Extrem-lower  1  0/337 (0.00%)  1/348 (0.29%) 
Muscle weakness, not d/t neuropathy - body/general  1  0/337 (0.00%)  1/348 (0.29%) 
Pain - Back  1  0/337 (0.00%)  3/348 (0.86%) 
Pain - Bone  1  1/337 (0.30%)  1/348 (0.29%) 
Pain - Joint  1  0/337 (0.00%)  2/348 (0.57%) 
Pain - Muscle  1  0/337 (0.00%)  1/348 (0.29%) 
Pain - Neck  1  0/337 (0.00%)  2/348 (0.57%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Death - Disease progression NOS  1  10/337 (2.97%)  4/348 (1.15%) 
Nervous system disorders     
CNS cerebrovascular ischemia  1  0/337 (0.00%)  1/348 (0.29%) 
Cognitive disturbance  1  0/337 (0.00%)  1/348 (0.29%) 
Dizziness  1  0/337 (0.00%)  1/348 (0.29%) 
Hemorrhage, CNS  1  1/337 (0.30%)  0/348 (0.00%) 
Neurology-Other  1  0/337 (0.00%)  1/348 (0.29%) 
Somnolence/depressed level of consciousness  1  0/337 (0.00%)  2/348 (0.57%) 
Speech impairment (e.g., dysphasia or aphasia)  1  0/337 (0.00%)  1/348 (0.29%) 
Syncope (fainting)  1  0/337 (0.00%)  1/348 (0.29%) 
Psychiatric disorders     
Confusion  1  1/337 (0.30%)  1/348 (0.29%) 
Mood alteration - agitation  1  0/337 (0.00%)  1/348 (0.29%) 
Renal and urinary disorders     
Renal failure  1  0/337 (0.00%)  1/348 (0.29%) 
Respiratory, thoracic and mediastinal disorders     
Adult respiratory distress syndrome (ARDS)  1  1/337 (0.30%)  0/348 (0.00%) 
Dyspnea (shortness of breath)  1  5/337 (1.48%)  1/348 (0.29%) 
Hypoxia  1  2/337 (0.59%)  2/348 (0.57%) 
Pain - Pleura  1  0/337 (0.00%)  1/348 (0.29%) 
Pneumonitis/pulmonary infiltrates  1  0/337 (0.00%)  1/348 (0.29%) 
Vascular disorders     
Hypotension  1  0/337 (0.00%)  2/348 (0.57%) 
Thrombosis/thrombus/embolism  1  1/337 (0.30%)  5/348 (1.44%) 
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%
Anastrozole Anastrozole & Fulvestrant
Affected / at Risk (%) Affected / at Risk (%)
Total   309/337 (91.69%)   322/348 (92.53%) 
Blood and lymphatic system disorders     
Hemoglobin  1  64/337 (18.99%)  80/348 (22.99%) 
Gastrointestinal disorders     
Constipation  1  89/337 (26.41%)  110/348 (31.61%) 
Diarrhea  1  64/337 (18.99%)  72/348 (20.69%) 
Dry mouth/salivary gland (xerostomia)  1  46/337 (13.65%)  47/348 (13.51%) 
Heartburn/dyspepsia  1  26/337 (7.72%)  15/348 (4.31%) 
Nausea  1  114/337 (33.83%)  119/348 (34.20%) 
Pain - Abdomen NOS  1  41/337 (12.17%)  47/348 (13.51%) 
Vomiting  1  60/337 (17.80%)  57/348 (16.38%) 
General disorders     
Edema: limb  1  72/337 (21.36%)  89/348 (25.57%) 
Fatigue (asthenia, lethargy, malaise)  1  203/337 (60.24%)  220/348 (63.22%) 
Fever in absence of neutropenia, ANC lt1.0x10e9/L  1  26/337 (7.72%)  21/348 (6.03%) 
Injection site reaction/extravasation changes  1  4/337 (1.19%)  48/348 (13.79%) 
Pain - Chest/thorax NOS  1  27/337 (8.01%)  52/348 (14.94%) 
Pain-Other  1  83/337 (24.63%)  108/348 (31.03%) 
Rigors/chills  1  28/337 (8.31%)  20/348 (5.75%) 
Infections and infestations     
Infection with unknown ANC - Urinary tract NOS  1  18/337 (5.34%)  22/348 (6.32%) 
Infection-Other  1  40/337 (11.87%)  47/348 (13.51%) 
Investigations     
ALT, SGPT (serum glutamic pyruvic transaminase)  1  36/337 (10.68%)  25/348 (7.18%) 
AST, SGOT  1  52/337 (15.43%)  43/348 (12.36%) 
Alkaline phosphatase  1  36/337 (10.68%)  46/348 (13.22%) 
Creatinine  1  36/337 (10.68%)  47/348 (13.51%) 
Leukocytes (total WBC)  1  37/337 (10.98%)  34/348 (9.77%) 
Lymphopenia  1  10/337 (2.97%)  22/348 (6.32%) 
Platelets  1  14/337 (4.15%)  26/348 (7.47%) 
Weight gain  1  31/337 (9.20%)  42/348 (12.07%) 
Weight loss  1  24/337 (7.12%)  21/348 (6.03%) 
Metabolism and nutrition disorders     
Albumin, serum-low (hypoalbuminemia)  1  18/337 (5.34%)  18/348 (5.17%) 
Anorexia  1  78/337 (23.15%)  74/348 (21.26%) 
Calcium, serum-high (hypercalcemia)  1  20/337 (5.93%)  25/348 (7.18%) 
Calcium, serum-low (hypocalcemia)  1  20/337 (5.93%)  25/348 (7.18%) 
Glucose, serum-high (hyperglycemia)  1  73/337 (21.66%)  95/348 (27.30%) 
Glucose, serum-low (hypoglycemia)  1  6/337 (1.78%)  18/348 (5.17%) 
Potassium, serum-high (hyperkalemia)  1  11/337 (3.26%)  25/348 (7.18%) 
Potassium, serum-low (hypokalemia)  1  27/337 (8.01%)  31/348 (8.91%) 
Sodium, serum-low (hyponatremia)  1  26/337 (7.72%)  29/348 (8.33%) 
Musculoskeletal and connective tissue disorders     
Muscle weakness, not d/t neuropathy - body/general  1  12/337 (3.56%)  18/348 (5.17%) 
Pain - Back  1  135/337 (40.06%)  130/348 (37.36%) 
Pain - Bone  1  93/337 (27.60%)  113/348 (32.47%) 
Pain - Extremity-limb  1  35/337 (10.39%)  47/348 (13.51%) 
Pain - Joint  1  152/337 (45.10%)  153/348 (43.97%) 
Pain - Muscle  1  80/337 (23.74%)  79/348 (22.70%) 
Nervous system disorders     
Dizziness  1  59/337 (17.51%)  65/348 (18.68%) 
Neuropathy: motor  1  27/337 (8.01%)  21/348 (6.03%) 
Neuropathy: sensory  1  69/337 (20.47%)  92/348 (26.44%) 
Pain - Head/headache  1  66/337 (19.58%)  81/348 (23.28%) 
Psychiatric disorders     
Confusion  1  19/337 (5.64%)  15/348 (4.31%) 
Insomnia  1  95/337 (28.19%)  97/348 (27.87%) 
Mood alteration - agitation  1  13/337 (3.86%)  18/348 (5.17%) 
Mood alteration - anxiety  1  58/337 (17.21%)  58/348 (16.67%) 
Mood alteration - depression  1  63/337 (18.69%)  79/348 (22.70%) 
Renal and urinary disorders     
Urinary frequency/urgency  1  8/337 (2.37%)  20/348 (5.75%) 
Reproductive system and breast disorders     
Pain - Pelvis  1  17/337 (5.04%)  24/348 (6.90%) 
Vaginal dryness  1  22/337 (6.53%)  24/348 (6.90%) 
Respiratory, thoracic and mediastinal disorders     
Allergic rhinitis  1  8/337 (2.37%)  19/348 (5.46%) 
Cough  1  91/337 (27.00%)  92/348 (26.44%) 
Dyspnea (shortness of breath)  1  96/337 (28.49%)  102/348 (29.31%) 
Skin and subcutaneous tissue disorders     
Dermatology/Skin-Other  1  12/337 (3.56%)  19/348 (5.46%) 
Hair loss/Alopecia (scalp or body)  1  11/337 (3.26%)  23/348 (6.61%) 
Pruritus/itching  1  27/337 (8.01%)  45/348 (12.93%) 
Rash/desquamation  1  45/337 (13.35%)  61/348 (17.53%) 
Sweating (diaphoresis)  1  53/337 (15.73%)  62/348 (17.82%) 
Vascular disorders     
Hot flashes/flushes  1  154/337 (45.70%)  189/348 (54.31%) 
Hypertension  1  49/337 (14.54%)  53/348 (15.23%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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: Breast Committee Statistician
Organization: SWOG
Phone: 206-667-4623
Layout table for additonal information
Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00075764    
Other Study ID Numbers: CDR0000349337
U10CA032102 ( U.S. NIH Grant/Contract )
S0226 ( Other Identifier: SWOG )
CAN-NCIC-MAC7 ( Other Identifier: NCIC-CTG )
First Submitted: January 9, 2004
First Posted: January 13, 2004
Results First Submitted: October 26, 2016
Results First Posted: April 4, 2017
Last Update Posted: January 13, 2021