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S0800, Nab-Paclitaxel, Doxorubicin, Cyclophosphamide, and Pegfilgrastim With or Without Bevacizumab in Treating Women With Inflammatory or Locally Advanced Breast Cancer

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ClinicalTrials.gov Identifier: NCT00856492
Recruitment Status : Completed
First Posted : March 5, 2009
Results First Posted : June 27, 2017
Last Update Posted : June 27, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
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 Biological: bevacizumab
Biological: pegfilgrastim
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: paclitaxel albumin-stabilized nanoparticle formulation
Enrollment 215

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm 1 (Nab-Paclitaxel + Bevacizumab / AC+PEG-G)) Arm 2 (Nab-Paclitaxel / AC+PEG-G) Arm 3 (AC+PEG-G / Nab-Paclitaxel)
Hide Arm/Group Description Received intravenous (IV) administration of nabpaclitaxel 100 mg/m2 IV weekly for 12 weeks (nP x 12) with IV bevacizumab 10 mg/kg every 2 weeks (six doses), followed by IV doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 with pegfilgrastim 6 mg subcutaneously every 2 weeks for six cycles (ddAC x 6). Received nP x 12 without bevacizumab followed by ddAC x 6 ddAC x 6 followed by nP x 12 without bevacizumab
Period Title: Overall Study
Started 99 63 53
Toxicity Eval [1] 96 60 51
Completed 98 62 51
Not Completed 1 1 2
Reason Not Completed
Ineligible or withdrew consent             1             1             2
[1]
Fewer pts evaluable for toxicity vs arm totals b/c 2 pts on each arm did not receive any treatment
Arm/Group Title Arm 1 (Nab-Paclitaxel + Bevacizumab / AC+PEG-G) Arm 2 (Nab-Paclitaxel / AC+PEG-G)) Arm 3 (AC+PEG-G / Nab-Paclitaxel) Total
Hide Arm/Group Description Received intravenous (IV) administration of nabpaclitaxel 100 mg/m2 IV weekly for 12 weeks (nP x 12) with IV bevacizumab 10 mg/kg every 2 weeks (six doses), followed by IV doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 with pegfilgrastim 6 mg subcutaneously every 2 weeks for six cycles (ddAC x 6). Received nP x 12 followed by ddAC x 6 without bevacizumab Received ddAC x 6 first followed by nP x 12, without bevacizumab Total of all reporting groups
Overall Number of Baseline Participants 98 62 51 211
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 98 participants 62 participants 51 participants 211 participants
51.7
(22 to 71)
49.7
(33 to 75)
51.6
(31 to 66)
51.5
(22 to 75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 98 participants 62 participants 51 participants 211 participants
Female
98
 100.0%
62
 100.0%
51
 100.0%
211
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race/Ethnicity Number Analyzed 98 participants 62 participants 51 participants 211 participants
White
70
  71.4%
44
  71.0%
40
  78.4%
154
  73.0%
Black
20
  20.4%
14
  22.6%
4
   7.8%
38
  18.0%
Asian/Pacific Islander
5
   5.1%
1
   1.6%
5
   9.8%
11
   5.2%
Other/unknown
3
   3.1%
3
   4.8%
2
   3.9%
8
   3.8%
Inflammatory Breast Cancer (IBC) or Non-IBC Locally Advanced Breast Cancer (LABC)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 98 participants 62 participants 51 participants 211 participants
IBC
10
  10.2%
7
  11.3%
7
  13.7%
24
  11.4%
Non-IBC LABC
88
  89.8%
55
  88.7%
44
  86.3%
187
  88.6%
Hormone receptor status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 98 participants 62 participants 51 participants 211 participants
Positive: ER+ or PgR+
66
  67.3%
43
  69.4%
35
  68.6%
144
  68.2%
Negative: ER- and PR- (TNBC)
32
  32.7%
19
  30.6%
16
  31.4%
67
  31.8%
Breast cancer stage   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 98 participants 62 participants 50 participants 210 participants
IIB
35
  35.7%
30
  48.4%
22
  44.0%
87
  41.4%
IIIA
32
  32.7%
16
  25.8%
14
  28.0%
62
  29.5%
IIIB
29
  29.6%
12
  19.4%
12
  24.0%
53
  25.2%
IIIC
2
   2.0%
4
   6.5%
2
   4.0%
8
   3.8%
[1]
Measure Description:

Measure Description: As per AJCC 6th ed, 2002:

https://cancerstaging.org/references-tools/deskreferences/Documents/AJCC6thEdCancerStagingManualPart2.pdf

[2]
Measure Analysis Population Description: One subject missing Breast cancer stage information at baseline.
1.Primary Outcome
Title Number of Patients With Pathological Complete Response Rate
Hide Description Pathologic complete response (pCR), commonly defined as the absence of residual invasive cancer in both the breast and axillary lymph nodes, has emerged as a surrogate endpoint for disease-free and overall survival, as the achievement of a pCR is associated with a favorable long-term prognosis in all breast cancer subtypes.
Time Frame pre-study pathology vs. post-chemo surgery pathology (approx. 39-42 weeks post-randomization)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pre-specified analysis of Arm 1 vs. Arm 2/3 to compare effect of bevacizumab
Arm/Group Title Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) Arm 2/3 (Nab-Paclitaxel/AC+PEG-G))
Hide Arm/Group Description:
Received intravenous (IV) administration of nabpaclitaxel 100 mg/m2 IV weekly for 12 weeks (nP x 12) with IV bevacizumab 10 mg/kg every 2 weeks (six doses), followed by IV doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 with pegfilgrastim 6 mg subcutaneously every 2 weeks for six cycles (ddAC x 6).
Received nP x 12 followed by ddAC x 6, or received ddAC x 6 first followed by nP x 12, without bevacizumab
Overall Number of Participants Analyzed 98 113
Measure Type: Count of Participants
Unit of Measure: Participants
35
  35.7%
24
  21.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)), Arm 2/3 (Nab-Paclitaxel/AC+PEG-G))
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.019
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Secondary Outcome
Title Overall Survival
Hide Description Time from registration to death due to any cause
Time Frame Disease assessed every 4 weeks while on treatment then every 6 months for one year then annually for four years from registration.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pre-specified analysis of Arm 1 vs. Arm 2/3 to compare effect of bevacizumab
Arm/Group Title Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) Arm 2/3 (Nab-Paclitaxel/AC+PEG-G))
Hide Arm/Group Description:
Received intravenous (IV) administration of nabpaclitaxel 100 mg/m2 IV weekly for 12 weeks (nP x 12) with IV bevacizumab 10 mg/kg every 2 weeks (six doses), followed by IV doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 with pegfilgrastim 6 mg subcutaneously every 2 weeks for six cycles (ddAC x 6).
Arm II received nP x 12 followed by ddAC x 6, and those randomized to Arm III received ddAC x 6 first followed by nP x 12, both without bevacizumab
Overall Number of Participants Analyzed 98 113
Measure Type: Number
Unit of Measure: deaths
14 17
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)), Arm 2/3 (Nab-Paclitaxel/AC+PEG-G))
Comments [Not Specified]
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]
3.Secondary Outcome
Title Event-free Survival
Hide Description Time from registration to first instance of any of the following events: progression prior to surgery, recurrence post-surgery or death from any cause.
Time Frame Disease assessed every 4 weeks while on treatment then every 6 months for one year then annually for four years from registration or until recurrence
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pre-specified analysis of Arm 1 vs. Arm 2/3 to compare effect of bevacizumab
Arm/Group Title Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) Arm 2/3 (Nab-Paclitaxel/AC+PEG-G))
Hide Arm/Group Description:
Received intravenous (IV) administration of nabpaclitaxel 100 mg/m2 IV weekly for 12 weeks (nP x 12) with IV bevacizumab 10 mg/kg every 2 weeks (six doses), followed by IV doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 with pegfilgrastim 6 mg subcutaneously every 2 weeks for six cycles (ddAC x 6).
Received nP x 12 followed by ddAC x 6, or received ddAC x 6 first followed by nP x 12, without bevacizumab
Overall Number of Participants Analyzed 98 113
Measure Type: Number
Unit of Measure: participants
20 24
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1 (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)), Arm 2/3 (Nab-Paclitaxel/AC+PEG-G))
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.71
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
4.Secondary Outcome
Title Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Hide Description Only adverse events that are possibly, probably or definitely related to study drug are reported.
Time Frame Up to 28 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants receiving at least some protocol treatment
Arm/Group Title Arm I (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) Arm II (Nab-Paclitaxel - AC+PEG-G) Arm III (AC+PEG-G - Nab-Paclitaxel)
Hide Arm/Group Description:
Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 and bevacizumab IV over 30- to 90-minutes on day 1 of weeks 1-12. Patients then receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 of weeks 14, 16, 18, 20, 22, and 24.
Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 of weeks 1-12. Patients then receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 of weeks 14, 16, 18, 20, 22, and 24.
Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 of weeks 1, 3, 5, 7, 9, and 11. Patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 of weeks 14-25.
Overall Number of Participants Analyzed 96 60 51
Measure Type: Number
Unit of Measure: Participants
Abdominal pain 2 0 0
Adult respiratory distress syndrome 1 0 0
Alanine aminotransferase increased 2 2 1
Anemia 13 6 13
Anorectal infection 2 0 0
Anxiety 0 0 1
Aspartate aminotransferase increased 0 0 1
Blood and lymphatic system disorders - Other 0 0 1
Bone pain 0 2 0
CD4 lymphocytes decreased 1 1 0
Catheter related infection 1 0 0
Chest wall pain 0 1 0
Confusion 1 0 0
Conjunctivitis 0 1 0
Dehydration 4 1 2
Dental caries 0 1 0
Depression 1 0 0
Device related infection 0 1 0
Diarrhea 3 1 1
Dysphagia 1 0 0
Dyspnea 3 0 1
Ear pain 1 0 0
Edema limbs 0 0 1
Ejection fraction decreased 1 0 1
Enterocolitis 0 0 1
Enterocolitis infectious 0 1 0
Erythema multiforme 1 0 0
Facial nerve disorder 1 0 0
Facial pain 0 1 0
Fatigue 7 7 4
Febrile neutropenia 10 5 3
Gait disturbance 0 1 0
Gastrointestinal disorders - Other, specify 1 0 0
Generalized muscle weakness 1 0 0
Headache 2 2 0
Heart failure 0 1 0
Hypercalcemia 0 1 0
Hyperglycemia 0 1 4
Hypertension 8 2 1
Hypokalemia 1 1 3
Hyponatremia 2 1 0
Hypophosphatemia 1 0 0
Hypotension 2 0 1
Insomnia 0 1 0
Leukocytosis 0 1 1
Lung infection 0 0 2
Lymphocyte count decreased 2 2 2
Mucositis oral 6 2 5
Myalgia 0 1 0
Nasal congestion 0 1 1
Nausea 6 6 4
Neutrophil count decreased 36 10 16
Non-cardiac chest pain 0 1 0
Oral pain 0 1 0
Otitis externa 1 0 0
Pain 2 2 0
Pain in extremity 0 1 1
Palmar-plantar erythrodysesthesia syndrome 1 0 2
Periorbital infection 1 0 0
Peripheral motor neuropathy 0 1 0
Peripheral sensory neuropathy 5 5 2
Platelet count decreased 6 3 0
Pneumonitis 2 0 2
Proctitis 1 0 0
Proteinuria 0 1 0
Rash maculo-papular 0 1 0
Rectal pain 0 1 0
Renal and urinary disorders - Other, specify 1 0 0
Respiratory failure 1 1 0
Sepsis 2 1 0
Skin and subcutaneous tissue disorders - Other 1 0 0
Skin infection 2 2 1
Suicide attempt 1 0 0
Syncope 1 0 1
Thromboembolic event 1 2 0
Tooth infection 0 1 1
Urinary tract infection 1 1 1
Vomiting 9 3 2
Vulval infection 1 0 0
Weight gain 1 0 0
Weight loss 0 0 1
White blood cell decreased 15 5 12
Time Frame Up to 25 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) Arm II (Nab-Paclitaxel - AC+PEG-G) Arm III (AC+PEG-G - Nab-Paclitaxel)
Hide Arm/Group Description Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 and bevacizumab IV over 30- to 90-minutes on day 1 of weeks 1-12. Patients then receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 of weeks 14, 16, 18, 20, 22, and 24. Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 of weeks 1-12. Patients then receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 of weeks 14, 16, 18, 20, 22, and 24. Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2 of weeks 1, 3, 5, 7, 9, and 11. Patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 of weeks 14-25.
All-Cause Mortality
Arm I (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) Arm II (Nab-Paclitaxel - AC+PEG-G) Arm III (AC+PEG-G - Nab-Paclitaxel)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm I (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) Arm II (Nab-Paclitaxel - AC+PEG-G) Arm III (AC+PEG-G - Nab-Paclitaxel)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   22/96 (22.92%)   3/60 (5.00%)   3/51 (5.88%) 
Blood and lymphatic system disorders       
Anemia   1/96 (1.04%)  1/60 (1.67%)  1/51 (1.96%) 
Febrile neutropenia   4/96 (4.17%)  1/60 (1.67%)  0/51 (0.00%) 
Cardiac disorders       
Heart failure   1/96 (1.04%)  1/60 (1.67%)  0/51 (0.00%) 
Gastrointestinal disorders       
Abdominal pain   1/96 (1.04%)  0/60 (0.00%)  0/51 (0.00%) 
Dysphagia   1/96 (1.04%)  0/60 (0.00%)  0/51 (0.00%) 
Mucositis oral   1/96 (1.04%)  0/60 (0.00%)  0/51 (0.00%) 
Nausea   1/96 (1.04%)  0/60 (0.00%)  1/51 (1.96%) 
Vomiting   2/96 (2.08%)  0/60 (0.00%)  1/51 (1.96%) 
General disorders       
Death NOS   0/96 (0.00%)  1/60 (1.67%)  0/51 (0.00%) 
Pain   1/96 (1.04%)  0/60 (0.00%)  0/51 (0.00%) 
Infections and infestations       
Catheter related infection   1/96 (1.04%)  0/60 (0.00%)  0/51 (0.00%) 
Enterocolitis infectious   0/96 (0.00%)  1/60 (1.67%)  0/51 (0.00%) 
Lung infection   0/96 (0.00%)  0/60 (0.00%)  1/51 (1.96%) 
Sepsis   2/96 (2.08%)  1/60 (1.67%)  0/51 (0.00%) 
Skin infection   2/96 (2.08%)  0/60 (0.00%)  1/51 (1.96%) 
Urinary tract infection   1/96 (1.04%)  0/60 (0.00%)  0/51 (0.00%) 
Investigations       
Ejection fraction decreased   1/96 (1.04%)  0/60 (0.00%)  0/51 (0.00%) 
Investigations-Other   1/96 (1.04%)  0/60 (0.00%)  0/51 (0.00%) 
Neutrophil count decreased   5/96 (5.21%)  0/60 (0.00%)  2/51 (3.92%) 
Platelet count decreased   1/96 (1.04%)  1/60 (1.67%)  0/51 (0.00%) 
Weight gain   1/96 (1.04%)  0/60 (0.00%)  0/51 (0.00%) 
White blood cell decreased   4/96 (4.17%)  1/60 (1.67%)  1/51 (1.96%) 
Metabolism and nutrition disorders       
Dehydration   1/96 (1.04%)  0/60 (0.00%)  0/51 (0.00%) 
Hyperglycemia   1/96 (1.04%)  0/60 (0.00%)  0/51 (0.00%) 
Hypokalemia   1/96 (1.04%)  0/60 (0.00%)  0/51 (0.00%) 
Hyponatremia   1/96 (1.04%)  0/60 (0.00%)  0/51 (0.00%) 
Musculoskeletal and connective tissue disorders       
Pain in extremity   1/96 (1.04%)  0/60 (0.00%)  0/51 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Neoplasms benign, malignant and unspecified - Other   1/96 (1.04%)  0/60 (0.00%)  0/51 (0.00%) 
Nervous system disorders       
Headache   1/96 (1.04%)  0/60 (0.00%)  0/51 (0.00%) 
Peripheral sensory neuropathy   1/96 (1.04%)  0/60 (0.00%)  0/51 (0.00%) 
Reversible posterior leukoencephalopathy syndrome   1/96 (1.04%)  0/60 (0.00%)  0/51 (0.00%) 
Psychiatric disorders       
Confusion   2/96 (2.08%)  0/60 (0.00%)  0/51 (0.00%) 
Renal and urinary disorders       
Acute kidney injury   1/96 (1.04%)  0/60 (0.00%)  0/51 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Adult respiratory distress syndrome   1/96 (1.04%)  0/60 (0.00%)  0/51 (0.00%) 
Dyspnea   0/96 (0.00%)  0/60 (0.00%)  1/51 (1.96%) 
Pneumonitis   2/96 (2.08%)  0/60 (0.00%)  0/51 (0.00%) 
Respiratory failure   0/96 (0.00%)  1/60 (1.67%)  0/51 (0.00%) 
Vascular disorders       
Hypertension   2/96 (2.08%)  0/60 (0.00%)  0/51 (0.00%) 
Thromboembolic event   2/96 (2.08%)  0/60 (0.00%)  0/51 (0.00%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm I (Nab-Paclitaxel + Bevacizumab - AC+PEG-G)) Arm II (Nab-Paclitaxel - AC+PEG-G) Arm III (AC+PEG-G - Nab-Paclitaxel)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   92/96 (95.83%)   58/60 (96.67%)   50/51 (98.04%) 
Blood and lymphatic system disorders       
Anemia   73/96 (76.04%)  43/60 (71.67%)  48/51 (94.12%) 
Febrile neutropenia   7/96 (7.29%)  4/60 (6.67%)  3/51 (5.88%) 
Cardiac disorders       
Sinus tachycardia   5/96 (5.21%)  1/60 (1.67%)  2/51 (3.92%) 
Ear and labyrinth disorders       
Ear pain   4/96 (4.17%)  1/60 (1.67%)  4/51 (7.84%) 
Eye disorders       
Blurred vision   6/96 (6.25%)  8/60 (13.33%)  5/51 (9.80%) 
Conjunctivitis   2/96 (2.08%)  1/60 (1.67%)  4/51 (7.84%) 
Dry eye   3/96 (3.13%)  2/60 (3.33%)  3/51 (5.88%) 
Eye disorders-Other   5/96 (5.21%)  4/60 (6.67%)  2/51 (3.92%) 
Watering eyes   20/96 (20.83%)  7/60 (11.67%)  11/51 (21.57%) 
Gastrointestinal disorders       
Abdominal pain   13/96 (13.54%)  7/60 (11.67%)  8/51 (15.69%) 
Anal pain   4/96 (4.17%)  3/60 (5.00%)  0/51 (0.00%) 
Bloating   4/96 (4.17%)  1/60 (1.67%)  4/51 (7.84%) 
Constipation   52/96 (54.17%)  24/60 (40.00%)  26/51 (50.98%) 
Diarrhea   46/96 (47.92%)  31/60 (51.67%)  27/51 (52.94%) 
Dry mouth   5/96 (5.21%)  1/60 (1.67%)  5/51 (9.80%) 
Dyspepsia   17/96 (17.71%)  7/60 (11.67%)  15/51 (29.41%) 
Dysphagia   9/96 (9.38%)  2/60 (3.33%)  2/51 (3.92%) 
Gastroesophageal reflux disease   8/96 (8.33%)  4/60 (6.67%)  5/51 (9.80%) 
Gastrointestinal disorders-Other   6/96 (6.25%)  2/60 (3.33%)  2/51 (3.92%) 
Hemorrhoids   6/96 (6.25%)  1/60 (1.67%)  4/51 (7.84%) 
Mucositis oral   42/96 (43.75%)  26/60 (43.33%)  29/51 (56.86%) 
Nausea   73/96 (76.04%)  49/60 (81.67%)  41/51 (80.39%) 
Oral pain   5/96 (5.21%)  1/60 (1.67%)  3/51 (5.88%) 
Rectal hemorrhage   6/96 (6.25%)  1/60 (1.67%)  0/51 (0.00%) 
Stomach pain   2/96 (2.08%)  3/60 (5.00%)  1/51 (1.96%) 
Vomiting   35/96 (36.46%)  32/60 (53.33%)  28/51 (54.90%) 
General disorders       
Chills   14/96 (14.58%)  7/60 (11.67%)  8/51 (15.69%) 
Edema limbs   8/96 (8.33%)  12/60 (20.00%)  9/51 (17.65%) 
Fatigue   85/96 (88.54%)  50/60 (83.33%)  45/51 (88.24%) 
Fever   12/96 (12.50%)  7/60 (11.67%)  12/51 (23.53%) 
Flu like symptoms   4/96 (4.17%)  3/60 (5.00%)  0/51 (0.00%) 
Non-cardiac chest pain   1/96 (1.04%)  4/60 (6.67%)  2/51 (3.92%) 
Pain   34/96 (35.42%)  23/60 (38.33%)  10/51 (19.61%) 
Infections and infestations       
Bronchial infection   1/96 (1.04%)  1/60 (1.67%)  3/51 (5.88%) 
Infections and infestations-Other   3/96 (3.13%)  2/60 (3.33%)  4/51 (7.84%) 
Lung infection   2/96 (2.08%)  0/60 (0.00%)  3/51 (5.88%) 
Nail infection   14/96 (14.58%)  2/60 (3.33%)  2/51 (3.92%) 
Sinusitis   6/96 (6.25%)  2/60 (3.33%)  1/51 (1.96%) 
Skin infection   10/96 (10.42%)  4/60 (6.67%)  7/51 (13.73%) 
Tooth infection   2/96 (2.08%)  4/60 (6.67%)  2/51 (3.92%) 
Upper respiratory infection   8/96 (8.33%)  3/60 (5.00%)  8/51 (15.69%) 
Urinary tract infection   7/96 (7.29%)  6/60 (10.00%)  4/51 (7.84%) 
Investigations       
Alanine aminotransferase increased   31/96 (32.29%)  18/60 (30.00%)  16/51 (31.37%) 
Alkaline phosphatase increased   20/96 (20.83%)  8/60 (13.33%)  16/51 (31.37%) 
Aspartate aminotransferase increased   25/96 (26.04%)  17/60 (28.33%)  19/51 (37.25%) 
CD4 lymphocytes decreased   1/96 (1.04%)  1/60 (1.67%)  3/51 (5.88%) 
Creatinine increased   8/96 (8.33%)  2/60 (3.33%)  2/51 (3.92%) 
Investigations-Other   10/96 (10.42%)  2/60 (3.33%)  3/51 (5.88%) 
Lymphocyte count decreased   6/96 (6.25%)  3/60 (5.00%)  8/51 (15.69%) 
Neutrophil count decreased   58/96 (60.42%)  24/60 (40.00%)  26/51 (50.98%) 
Platelet count decreased   21/96 (21.88%)  11/60 (18.33%)  13/51 (25.49%) 
Weight loss   27/96 (28.13%)  6/60 (10.00%)  13/51 (25.49%) 
White blood cell decreased   48/96 (50.00%)  22/60 (36.67%)  29/51 (56.86%) 
Metabolism and nutrition disorders       
Anorexia   35/96 (36.46%)  19/60 (31.67%)  20/51 (39.22%) 
Dehydration   8/96 (8.33%)  5/60 (8.33%)  7/51 (13.73%) 
Hyperglycemia   32/96 (33.33%)  14/60 (23.33%)  19/51 (37.25%) 
Hypertriglyceridemia   0/96 (0.00%)  3/60 (5.00%)  1/51 (1.96%) 
Hypoalbuminemia   17/96 (17.71%)  7/60 (11.67%)  11/51 (21.57%) 
Hypocalcemia   21/96 (21.88%)  6/60 (10.00%)  5/51 (9.80%) 
Hypoglycemia   4/96 (4.17%)  3/60 (5.00%)  1/51 (1.96%) 
Hypokalemia   22/96 (22.92%)  11/60 (18.33%)  19/51 (37.25%) 
Hypomagnesemia   7/96 (7.29%)  1/60 (1.67%)  4/51 (7.84%) 
Hyponatremia   14/96 (14.58%)  4/60 (6.67%)  11/51 (21.57%) 
Musculoskeletal and connective tissue disorders       
Arthralgia   24/96 (25.00%)  12/60 (20.00%)  13/51 (25.49%) 
Back pain   14/96 (14.58%)  4/60 (6.67%)  7/51 (13.73%) 
Bone pain   8/96 (8.33%)  12/60 (20.00%)  13/51 (25.49%) 
Chest wall pain   3/96 (3.13%)  3/60 (5.00%)  3/51 (5.88%) 
Generalized muscle weakness   5/96 (5.21%)  8/60 (13.33%)  6/51 (11.76%) 
Myalgia   27/96 (28.13%)  9/60 (15.00%)  17/51 (33.33%) 
Neck pain   6/96 (6.25%)  0/60 (0.00%)  3/51 (5.88%) 
Pain in extremity   19/96 (19.79%)  10/60 (16.67%)  8/51 (15.69%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Tumor pain   1/96 (1.04%)  4/60 (6.67%)  3/51 (5.88%) 
Nervous system disorders       
Dizziness   23/96 (23.96%)  12/60 (20.00%)  16/51 (31.37%) 
Dysgeusia   35/96 (36.46%)  11/60 (18.33%)  9/51 (17.65%) 
Headache   45/96 (46.88%)  26/60 (43.33%)  19/51 (37.25%) 
Memory impairment   4/96 (4.17%)  3/60 (5.00%)  1/51 (1.96%) 
Paresthesia   3/96 (3.13%)  4/60 (6.67%)  1/51 (1.96%) 
Peripheral motor neuropathy   4/96 (4.17%)  5/60 (8.33%)  1/51 (1.96%) 
Peripheral sensory neuropathy   69/96 (71.88%)  40/60 (66.67%)  30/51 (58.82%) 
Psychiatric disorders       
Anxiety   15/96 (15.63%)  10/60 (16.67%)  7/51 (13.73%) 
Depression   17/96 (17.71%)  9/60 (15.00%)  9/51 (17.65%) 
Insomnia   33/96 (34.38%)  15/60 (25.00%)  10/51 (19.61%) 
Renal and urinary disorders       
Proteinuria   7/96 (7.29%)  2/60 (3.33%)  1/51 (1.96%) 
Urinary frequency   4/96 (4.17%)  0/60 (0.00%)  3/51 (5.88%) 
Urinary tract pain   5/96 (5.21%)  1/60 (1.67%)  0/51 (0.00%) 
Reproductive system and breast disorders       
Breast pain   16/96 (16.67%)  10/60 (16.67%)  6/51 (11.76%) 
Irregular menstruation   3/96 (3.13%)  4/60 (6.67%)  1/51 (1.96%) 
Menorrhagia   0/96 (0.00%)  3/60 (5.00%)  0/51 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Allergic rhinitis   17/96 (17.71%)  4/60 (6.67%)  8/51 (15.69%) 
Cough   32/96 (33.33%)  14/60 (23.33%)  16/51 (31.37%) 
Dyspnea   36/96 (37.50%)  19/60 (31.67%)  21/51 (41.18%) 
Epistaxis   43/96 (44.79%)  5/60 (8.33%)  4/51 (7.84%) 
Hoarseness   8/96 (8.33%)  2/60 (3.33%)  0/51 (0.00%) 
Nasal congestion   16/96 (16.67%)  9/60 (15.00%)  6/51 (11.76%) 
Postnasal drip   6/96 (6.25%)  1/60 (1.67%)  1/51 (1.96%) 
Productive cough   7/96 (7.29%)  2/60 (3.33%)  2/51 (3.92%) 
Sinus disorder   12/96 (12.50%)  5/60 (8.33%)  4/51 (7.84%) 
Sore throat   16/96 (16.67%)  5/60 (8.33%)  5/51 (9.80%) 
Voice alteration   3/96 (3.13%)  1/60 (1.67%)  3/51 (5.88%) 
Skin and subcutaneous tissue disorders       
Alopecia   56/96 (58.33%)  37/60 (61.67%)  30/51 (58.82%) 
Dry skin   10/96 (10.42%)  7/60 (11.67%)  10/51 (19.61%) 
Erythema multiforme   4/96 (4.17%)  3/60 (5.00%)  4/51 (7.84%) 
Nail discoloration   30/96 (31.25%)  15/60 (25.00%)  19/51 (37.25%) 
Nail loss   13/96 (13.54%)  5/60 (8.33%)  8/51 (15.69%) 
Nail ridging   13/96 (13.54%)  5/60 (8.33%)  6/51 (11.76%) 
Pain of skin   7/96 (7.29%)  2/60 (3.33%)  3/51 (5.88%) 
Palmar-plantar erythrodysesthesia syndrome   5/96 (5.21%)  1/60 (1.67%)  6/51 (11.76%) 
Pruritus   16/96 (16.67%)  10/60 (16.67%)  4/51 (7.84%) 
Rash acneiform   13/96 (13.54%)  7/60 (11.67%)  2/51 (3.92%) 
Rash maculo-papular   37/96 (38.54%)  10/60 (16.67%)  10/51 (19.61%) 
Skin and subcutaneous tissue disorders - Other   12/96 (12.50%)  5/60 (8.33%)  3/51 (5.88%) 
Skin hyperpigmentation   14/96 (14.58%)  5/60 (8.33%)  3/51 (5.88%) 
Vascular disorders       
Flushing   5/96 (5.21%)  1/60 (1.67%)  1/51 (1.96%) 
Hot flashes   20/96 (20.83%)  11/60 (18.33%)  13/51 (25.49%) 
Hypertension   36/96 (37.50%)  10/60 (16.67%)  5/51 (9.80%) 
Hypotension   12/96 (12.50%)  5/60 (8.33%)  4/51 (7.84%) 
Thromboembolic event   5/96 (5.21%)  4/60 (6.67%)  2/51 (3.92%) 
Indicates events were collected by systematic assessment
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
Name/Title: Breast Committee Statistician
Organization: SWOG Statistical Center
Phone: 206-667-4623
Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00856492     History of Changes
Other Study ID Numbers: CDR0000636131
S0800 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Submitted: March 4, 2009
First Posted: March 5, 2009
Results First Submitted: November 15, 2016
Results First Posted: June 27, 2017
Last Update Posted: June 27, 2017