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Trial to Evaluate Genomic Expression Profiles to Direct Preoperative Chemotherapy in Early Stage 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: NCT00636441
Recruitment Status : Terminated (Study terminated due to reproducibility issues with genomics prediction model)
First Posted : March 14, 2008
Results First Posted : October 7, 2014
Last Update Posted : December 11, 2015
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Early-Stage Breast Cancer
Intervention Drug: Doxorubicin/Cyclophosphamide (AC) or Docetaxel/Cyclophosphamide (TC)
Enrollment 56
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Guided AC Sensitive Guided TC Sensitive Guided AC Non-sensitive Guided TC Non-Sensitive Non-guided AC Non-guided TC Screen Failure
Hide Arm/Group Description

Genomically-guided >60% probability of response to AC

AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy

Genomically-guided treatment >60% probability of response to TC

TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy

Genomics guided treatment <60% probability of response to both AC and TC; randomized to AC

AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy

Genomics guided treatment <60% probability of response to both AC and TC; randomized to TC

TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy

Non-genomics guided treatment; randomized to AC

AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy

Non-genomics guided treatment; randomized to TC

TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy

[Not Specified]
Period Title: Overall Study
Started 6 7 6 6 6 7 18
Assigned Treatment 6 7 6 6 6 7 1 [1]
Completed 6 6 5 6 6 6 0
Not Completed 0 1 1 0 0 1 18
Reason Not Completed
Adverse Event             0             1             1             0             0             1             0
Late, ineligible             0             0             0             0             0             0             1
Screen Failure             0             0             0             0             0             0             17
[1]
This is a late determined ineligibility.
Arm/Group Title Guided AC Sensitive Guided TC Sensitive Guided AC Non-sensitive Guided TC Non-Sensitive Non-guided AC Non-guided TC Screen Failure Total
Hide Arm/Group Description

Genomically-guided >60% probability of response to AC

AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy

Genomically-guided treatment >60% probability of response to TC

TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy

Genomics guided treatment <60% probability of response to both AC and TC; randomized to AC

AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy

Genomics guided treatment <60% probability of response to both AC and TC; randomized to TC

TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy

Non-genomics guided treatment; randomized to AC

AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy

Non-genomics guided treatment; randomized to TC

TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy

[Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 6 7 6 6 6 7 18 56
Hide Baseline Analysis Population Description
All patients who signed a consent form are included in the baseline analysis.
Age, Continuous  
Median (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 7 participants 6 participants 6 participants 6 participants 7 participants 18 participants 56 participants
48.6  (8.7) 51.2  (7.3) 52.6  (8.0) 48.8  (9.1) 53.5  (6.7) 58.9  (12.9) 52.5  (13.0) 52.4  (10.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 7 participants 6 participants 6 participants 6 participants 7 participants 18 participants 56 participants
Female
6
 100.0%
7
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
7
 100.0%
18
 100.0%
56
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants 7 participants 6 participants 6 participants 6 participants 7 participants 18 participants 56 participants
6 7 6 6 6 7 18 56
1.Primary Outcome
Title Pathologic Complete Response (pCR) Rate in Patients With HER2-negative Early-stage Breast Cancer
Hide Description Pathological complete response (pCR) was defined as the disappearance of all invasive disease in the breast or if only residual in situ or lymph node disease is found. The pCR rate is presented with its 95% confidence interval for the Guided and Non-guided arms.
Time Frame 4-5 weeks after the fourth cycle of chemotherapy; approximately 16-17 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible treated patients. The three patients not included are two who had allergic reactions to the assigned treatment, and one with metastatic disease on biopsy of a spine lesion at the end of assigned treatment so never went to surgery.
Arm/Group Title Guided Arm Non-Guided Arm
Hide Arm/Group Description:
Genomically-guided treatment allocation.
Non-genomically-guided treatment allocation.
Overall Number of Participants Analyzed 24 11
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
16.7
(4.7 to 37.4)
9.1
(0.2 to 41.3)
2.Secondary Outcome
Title Probabilities of Being Sensitive to AC and TC as Determined by the Patient's Genomic Signatures
Hide Description To determine in early stage breast cancer treated with PST whether genomic profiling can identify drug-sensitive and drug-resistant patients including a comparison of subgroups for the two individual regimens (i.e. AC and TC). To determine if the 60% cutoff for the genomic profiles is optimal in predicting the response to chemotherapy regimens.To describe the performance of the genomic profiles in assessing the relative responsiveness of: 1) Patients predicted to be resistant to both chemotherapy regimens; and 2) Patients randomly assigned to one treatment whose genomic profiles suggest receiving the other regimen (in both AC and TC subgroups).
Time Frame 10 years
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome is not summarized due to irreproducibility of the genomics-based prediction model and resulting probability estimates
Arm/Group Title Guided Arm Non-Guided Arm
Hide Arm/Group Description:
Genomically-guided treatment allocation.
Non-genomically-guided treatment allocation.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Percentage of Patients Who Had Breast-conserving Surgery With Negative Margins
Hide Description The percentage of patients who had breast-conserving surgery with negative margins, measured in patients with T2 and T3 tumors classified as requiring mastectomy at baseline.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Since final margin status was not collected, this analysis could not be done.
Arm/Group Title Guided Arm Non-Guided Arm
Hide Arm/Group Description:
Genomically-guided treatment allocation.
Non-genomically-guided treatment allocation.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title To Percentage of Patients Who Had Breast-conserving Surgery at First Attempt.
Hide Description The percentage of patients who had breast-conserving surgery at first attempt, measured only in patients with T2 tumors classified as potential candidates for breast conservation.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data from all eligible patients with non-missing values on this outcome were used.
Arm/Group Title Guided Arm Non-Guided Arm
Hide Arm/Group Description:
Genomically-guided treatment allocation.
Non-genomically-guided treatment allocation.
Overall Number of Participants Analyzed 3 1
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of T2 tumor patients
67
(9 to 99)
100 [1] 
(NA to NA)
[1]
can not calculate confidence interval N of 1.
5.Secondary Outcome
Title Clinical Response Using WHO Criteria
Hide Description

WHO criteria are based on the sum of the products of the longest axis and the longest perpendicular axis. Bi-dimensional measurements were taken of all breast lesions and axillary nodes using the best imaging modality performed after completion of assigned therapy.

Clinical Complete Response (cCR): Disappearance of all target lesions by physical exam and best imaging modality.

Clinical Partial Response (cPR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.

Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the sum LD at treatment initiation. Patients having a documented response with no reconfirmation of the response will be listed with stable disease.

Progression (PD): At least a 20% increase in the sum of the LD of target lesions or the appearance of one or more new lesion.

Time Frame 12 weeks, 2-3 weeks after the fourth cycle of chemotherapy
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible treated patients were used in this analysis.
Arm/Group Title Guided Arm Non-Guided Arm
Hide Arm/Group Description:
Genomically-guided treatment allocation.
Non-genomically-guided treatment allocation.
Overall Number of Participants Analyzed 25 13
Measure Type: Number
Unit of Measure: participants
Complete Response (cCR) 2 2
Partial Response (cPR) 15 7
Stable Disease 6 2
Progressive Disease 1 0
Not Evaluable/Not Assessed 1 2
6.Secondary Outcome
Title Disease-free Survival
Hide Description Disease-free survival is defined as the length of time from enrollment to local or distant disease recurrence, whichever comes first; disease-free deaths are censored. The 2-year disease-free survival rate is estimated with its 95% confidence interval.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible treated patients were used in this analysis.
Arm/Group Title Guided Arm Non-Guided Arm
Hide Arm/Group Description:
Genomically-guided treatment allocation.
Non-genomically-guided treatment allocation.
Overall Number of Participants Analyzed 25 13
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: estimated % of participants disease-free
92
(71 to 98)
89
(43 to 98)
7.Secondary Outcome
Title Sites of Recurrence
Hide Description Sites of Recurrence is a categorical outcome whose possible values are the organ-specific sites at which disease recurrence was observed. A patient may recur at more than one site.
Time Frame 10 years
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible treated patients. Four of these 38 participants experienced recurrence of their breast cancer; two of the four patients had multiple sites of recurrence.
Arm/Group Title Guided Arm Non-Guided Arm
Hide Arm/Group Description:
Genomically-guided treatment allocation.
Non-genomically-guided treatment allocation.
Overall Number of Participants Analyzed 25 13
Measure Type: Number
Unit of Measure: participants
Bone 3 1
Brain 1 0
Chest Wall 1 0
Liver 2 0
Lung 1 0
8.Secondary Outcome
Title Overall Survival
Hide Description Overall survival is defined as the time from enrollment to death due to any cause. The 2-year overall survival rate is estimated with the Kaplan-Meier method.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible treated patients with known follow-up status.
Arm/Group Title Guided Arm Non-Guided Arm
Hide Arm/Group Description:
Genomically-guided treatment allocation.
Non-genomically-guided treatment allocation.
Overall Number of Participants Analyzed 24 12
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Estimated % of participants surviving
96
(74 to 99)
100 [1] 
(NA to NA)
[1]
Since no deaths occurred on or before the 2-year time point a confidence interval cannot be estimated.
9.Secondary Outcome
Title Economic Impact of Using Genomic Assessment to Guide Management.
Hide Description Economic Impact (i.e., cost of care) will be calculated by first assessing the quantity of clinical resources used by each patient in the study arm, and then assigning a cost to each resource using cost information derived from a costing study to be undertaken outside of this protocol.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Since these data were not collected, this analysis could not be done.
Arm/Group Title Guided Arm Non-Guided Arm
Hide Arm/Group Description:
Genomically-guided treatment allocation.
Non-genomically-guided treatment allocation.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Patients' Perceptions of Participating in a Clinical Trial Evaluating Cancer Genomics for PST of Early-stage Breast Cancer.
Hide Description A short questionnaire was administered at baseline (the day chemotherapy was started) and following post-surgical medical oncology evaluation to assess the patient's understanding of the study being conducted, and the patient's expectations of the treatment. Due to space limitations, the full survey is presented in the Detailed Description.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
The overall enrollment was insufficient to provide for any substantive analysis.
Arm/Group Title Guided Arm Non-Guided Arm
Hide Arm/Group Description:
Genomically-guided treatment allocation.
Non-genomically-guided treatment allocation.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Guided AC Sensitive Guided TC Sensitive Guided AC Non-sensitive Guided TC Non-Sensitive Non-guided AC Non-guided TC Screen Failures
Hide Arm/Group Description

Genomically-guided >60% probability of response to AC

AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy

Genomically-guided treatment >60% probability of response to TC

TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy

Genomics guided treatment <60% probability of response to both AC and TC; randomized to AC

AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy

Genomics guided treatment <60% probability of response to both AC and TC; randomized to TC

TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy

Non-genomics guided treatment; randomized to AC

AC: Doxorubicin 60 mg/m² and Cyclophosphamide 600 mg/m² (AC) every 3 weeks for 4 cycles as neoadjuvant therapy

Non-genomics guided treatment; randomized to TC

TC: Docetaxel 75 mg/m² and Cyclophosphamide 600 mg/m² (TC) every 3 weeks for 4 cycles as neoadjuvant therapy

Screen failures constitute patients who were registered to the study but were not assigned treatment for various reasons.
All-Cause Mortality
Guided AC Sensitive Guided TC Sensitive Guided AC Non-sensitive Guided TC Non-Sensitive Non-guided AC Non-guided TC Screen Failures
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Guided AC Sensitive Guided TC Sensitive Guided AC Non-sensitive Guided TC Non-Sensitive Non-guided AC Non-guided TC Screen Failures
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/6 (33.33%)   0/7 (0.00%)   3/6 (50.00%)   2/6 (33.33%)   1/6 (16.67%)   2/7 (28.57%)   1/18 (5.56%) 
Blood and lymphatic system disorders               
Anemia  1  0/6 (0.00%)  0/7 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  1/18 (5.56%) 
Febrile neutropenia  1  1/6 (16.67%)  0/7 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%)  0/18 (0.00%) 
Ear and labyrinth disorders               
Ear and labyrinth disorders: ear complete hearing loss  1  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/18 (0.00%) 
Gastrointestinal disorders               
Abdominal pain  1  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%)  0/18 (0.00%) 
Immune system disorders               
Allergic reaction  1  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/18 (0.00%) 
Infections and infestations               
Infections and infestations: Infection with neutrophils: Abdomen NOS  1  0/6 (0.00%)  0/7 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/18 (0.00%) 
Infections and infestations: UTI  1  1/6 (16.67%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/18 (0.00%) 
Investigations               
Neutrophil count decreased  1  2/6 (33.33%)  0/7 (0.00%)  2/6 (33.33%)  1/6 (16.67%)  0/6 (0.00%)  1/7 (14.29%)  0/18 (0.00%) 
White blood cell decreased  1  1/6 (16.67%)  0/7 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%)  0/18 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Guided AC Sensitive Guided TC Sensitive Guided AC Non-sensitive Guided TC Non-Sensitive Non-guided AC Non-guided TC Screen Failures
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/6 (100.00%)   7/7 (100.00%)   6/6 (100.00%)   6/6 (100.00%)   6/6 (100.00%)   7/7 (100.00%)   1/18 (5.56%) 
Blood and lymphatic system disorders               
Anemia  1  3/6 (50.00%)  3/7 (42.86%)  1/6 (16.67%)  2/6 (33.33%)  1/6 (16.67%)  3/7 (42.86%)  0/18 (0.00%) 
Lymph node pain  1  2/6 (33.33%)  0/7 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/6 (16.67%)  1/7 (14.29%)  0/18 (0.00%) 
Cardiac disorders               
Cardiac disorders: Tachycardia  1  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/18 (0.00%) 
Cardiac disorders: palpitations  1  0/6 (0.00%)  1/7 (14.29%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/18 (0.00%) 
Palpitations  1  0/6 (0.00%)  0/7 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  2/6 (33.33%)  1/7 (14.29%)  0/18 (0.00%) 
Ear and labyrinth disorders               
External ear inflammation  1  0/6 (0.00%)  0/7 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/18 (0.00%) 
Tinnitus  1  0/6 (0.00%)  0/7 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/18 (0.00%) 
Eye disorders               
Blurred vision  1  0/6 (0.00%)  1/7 (14.29%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/7 (28.57%)  0/18 (0.00%) 
Dry eye  1  0/6 (0.00%)  0/7 (0.00%)  2/6 (33.33%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/18 (0.00%) 
Extraocular muscle paresis  1  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/18 (0.00%) 
Eye disorders: eye lids twitching  1  0/6 (0.00%)  1/7 (14.29%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/18 (0.00%) 
Watering eyes  1  0/6 (0.00%)  2/7 (28.57%)  1/6 (16.67%)  1/6 (16.67%)  1/6 (16.67%)  2/7 (28.57%)  0/18 (0.00%) 
Gastrointestinal disorders               
Abdominal pain  1  1/6 (16.67%)  0/7 (0.00%)  0/6 (0.00%)  2/6 (33.33%)  0/6 (0.00%)  1/7 (14.29%)  0/18 (0.00%) 
Anal mucositis  1  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/7 (14.29%)  0/18 (0.00%) 
Ascites  1  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%)  0/18 (0.00%) 
Constipation  1  2/6 (33.33%)  5/7 (71.43%)  4/6 (66.67%)  3/6 (50.00%)  4/6 (66.67%)  3/7 (42.86%)  0/18 (0.00%) 
Diarrhea  1  1/6 (16.67%)  4/7 (57.14%)  1/6 (16.67%)  3/6 (50.00%)  1/6 (16.67%)  3/7 (42.86%)  0/18 (0.00%) 
Dry mouth  1  1/6 (16.67%)  1/7 (14.29%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/18 (0.00%) 
Dyspepsia  1  0/6 (0.00%)  0/7 (0.00%)  1/6 (16.67%)  2/6 (33.33%)  1/6 (16.67%)  1/7 (14.29%)  0/18 (0.00%) 
Dysphagia  1  0/6 (0.00%)  0/7 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/18 (0.00%) 
Esophagitis  1  0/6 (0.00%)  0/7 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/18 (0.00%) 
Gastrointestinal disorders: inflamed gums  1  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/7 (14.29%)  0/18 (0.00%) 
Hemorrhoids  1  2/6 (33.33%)  0/7 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/6 (16.67%)  2/7 (28.57%)  0/18 (0.00%) 
Mucositis oral  1  2/6 (33.33%)  3/7 (42.86%)  2/6 (33.33%)  3/6 (50.00%)  1/6 (16.67%)  3/7 (42.86%)  0/18 (0.00%) 
Nausea  1  2/6 (33.33%)  2/7 (28.57%)  4/6 (66.67%)  2/6 (33.33%)  2/6 (33.33%)  3/7 (42.86%)  0/18 (0.00%) 
Rectal hemorrhage  1  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/18 (0.00%) 
Rectal pain  1  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/18 (0.00%) 
Vomiting  1  3/6 (50.00%)  1/7 (14.29%)  3/6 (50.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/18 (0.00%) 
General disorders               
Edema face  1  0/6 (0.00%)  1/7 (14.29%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/18 (0.00%) 
Edema limbs  1  2/6 (33.33%)  3/7 (42.86%)  1/6 (16.67%)  1/6 (16.67%)  1/6 (16.67%)  1/7 (14.29%)  0/18 (0.00%) 
Edema trunk  1  2/6 (33.33%)  0/7 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/18 (0.00%) 
Fatigue  1  2/6 (33.33%)  5/7 (71.43%)  5/6 (83.33%)  6/6 (100.00%)  5/6 (83.33%)  6/7 (85.71%)  0/18 (0.00%) 
Fever  1  1/6 (16.67%)  1/7 (14.29%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/18 (0.00%) 
General disorders and administration site conditions: cold intolerance  1  1/6 (16.67%)  2/7 (28.57%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/7 (14.29%)  0/18 (0.00%) 
Non-cardiac chest pain  1  0/6 (0.00%)  1/7 (14.29%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/18 (0.00%) 
Pain  1  1/6 (16.67%)  1/7 (14.29%)  1/6 (16.67%)  2/6 (33.33%)  1/6 (16.67%)  1/7 (14.29%)  0/18 (0.00%) 
Immune system disorders               
Allergic reaction  1  0/6 (0.00%)  2/7 (28.57%)  1/6 (16.67%)  1/6 (16.67%)  0/6 (0.00%)  2/7 (28.57%)  0/18 (0.00%) 
Infections and infestations               
Infections and infestations: UTI  1  2/6 (33.33%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/18 (0.00%) 
Lymph gland infection  1  0/6 (0.00%)  0/7 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/18 (0.00%) 
Urinary tract infection  1  0/6 (0.00%)  1/7 (14.29%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/18 (0.00%) 
Vaginal infection  1  0/6 (0.00%)  1/7 (14.29%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%)  0/18 (0.00%) 
Injury, poisoning and procedural complications               
Bruising  1  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%)  0/18 (0.00%) 
Investigations               
Alanine aminotransferase increased  1  0/6 (0.00%)  1/7 (14.29%)  1/6 (16.67%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%)  0/18 (0.00%) 
Alkaline phosphatase increased  1  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%)  0/18 (0.00%) 
Aspartate aminotransferase increased  1  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%)  0/18 (0.00%) 
Neutrophil count decreased  1  1/6 (16.67%)  0/7 (0.00%)  3/6 (50.00%)  1/6 (16.67%)  2/6 (33.33%)  1/7 (14.29%)  0/18 (0.00%) 
Platelet count decreased  1  1/6 (16.67%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/18 (0.00%) 
Weight gain  1  0/6 (0.00%)  1/7 (14.29%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/18 (0.00%) 
Weight loss  1  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/18 (0.00%) 
White blood cell decreased  1  2/6 (33.33%)  0/7 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  2/6 (33.33%)  2/7 (28.57%)  0/18 (0.00%) 
Metabolism and nutrition disorders               
Acidosis  1  1/6 (16.67%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/18 (0.00%) 
Anorexia  1  0/6 (0.00%)  2/7 (28.57%)  1/6 (16.67%)  5/6 (83.33%)  1/6 (16.67%)  5/7 (71.43%)  0/18 (0.00%) 
Hyperglycemia  1  2/6 (33.33%)  2/7 (28.57%)  0/6 (0.00%)  2/6 (33.33%)  0/6 (0.00%)  4/7 (57.14%)  0/18 (0.00%) 
Hyperkalemia  1  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/7 (14.29%)  0/18 (0.00%) 
Hypernatremia  1  1/6 (16.67%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/18 (0.00%) 
Hypocalcemia  1  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/18 (0.00%) 
Hypokalemia  1  1/6 (16.67%)  0/7 (0.00%)  2/6 (33.33%)  1/6 (16.67%)  1/6 (16.67%)  1/7 (14.29%)  0/18 (0.00%) 
Hyponatremia  1  1/6 (16.67%)  1/7 (14.29%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/18 (0.00%) 
Musculoskeletal and connective tissue disorders               
Arthralgia  1  2/6 (33.33%)  2/7 (28.57%)  3/6 (50.00%)  2/6 (33.33%)  0/6 (0.00%)  5/7 (71.43%)  0/18 (0.00%) 
Arthritis  1  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%)  0/18 (0.00%) 
Back pain  1  4/6 (66.67%)  1/7 (14.29%)  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  2/7 (28.57%)  0/18 (0.00%) 
Bone pain  1  0/6 (0.00%)  1/7 (14.29%)  1/6 (16.67%)  1/6 (16.67%)  1/6 (16.67%)  1/7 (14.29%)  0/18 (0.00%) 
Chest wall pain  1  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%)  0/18 (0.00%) 
Generalized muscle weakness  1  0/6 (0.00%)  0/7 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/18 (0.00%) 
Musculoskeletal and connective tissue disorder : muscle tightness  1  0/6 (0.00%)  1/7 (14.29%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/18 (0.00%) 
Myalgia  1  1/6 (16.67%)  2/7 (28.57%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/18 (0.00%) 
Neck pain  1  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/7 (28.57%)  0/18 (0.00%) 
Pain in extremity  1  2/6 (33.33%)  2/7 (28.57%)  1/6 (16.67%)  1/6 (16.67%)  1/6 (16.67%)  2/7 (28.57%)  0/18 (0.00%) 
Nervous system disorders               
Ataxia  1  0/6 (0.00%)  0/7 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/18 (0.00%) 
Dizziness  1  0/6 (0.00%)  2/7 (28.57%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  2/7 (28.57%)  0/18 (0.00%) 
Dysgeusia  1  3/6 (50.00%)  3/7 (42.86%)  2/6 (33.33%)  3/6 (50.00%)  0/6 (0.00%)  4/7 (57.14%)  0/18 (0.00%) 
Headache  1  5/6 (83.33%)  4/7 (57.14%)  5/6 (83.33%)  5/6 (83.33%)  4/6 (66.67%)  3/7 (42.86%)  0/18 (0.00%) 
Memory impairment  1  1/6 (16.67%)  1/7 (14.29%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/18 (0.00%) 
Peripheral sensory neuropathy  1  3/6 (50.00%)  3/7 (42.86%)  2/6 (33.33%)  1/6 (16.67%)  2/6 (33.33%)  4/7 (57.14%)  0/18 (0.00%) 
Sinus pain  1  0/6 (0.00%)  0/7 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/18 (0.00%) 
Syncope  1  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/18 (0.00%) 
Psychiatric disorders               
Agitation  1  1/6 (16.67%)  0/7 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/18 (0.00%) 
Anxiety  1  0/6 (0.00%)  1/7 (14.29%)  0/6 (0.00%)  0/6 (0.00%)  3/6 (50.00%)  1/7 (14.29%)  0/18 (0.00%) 
Depression  1  1/6 (16.67%)  4/7 (57.14%)  0/6 (0.00%)  2/6 (33.33%)  0/6 (0.00%)  1/7 (14.29%)  0/18 (0.00%) 
Insomnia  1  3/6 (50.00%)  4/7 (57.14%)  3/6 (50.00%)  4/6 (66.67%)  2/6 (33.33%)  4/7 (57.14%)  0/18 (0.00%) 
Renal and urinary disorders               
Cystitis noninfective  1  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%)  0/18 (0.00%) 
Urinary frequency  1  1/6 (16.67%)  0/7 (0.00%)  2/6 (33.33%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%)  0/18 (0.00%) 
Urinary tract pain  1  1/6 (16.67%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/18 (0.00%) 
Reproductive system and breast disorders               
Breast pain  1  2/6 (33.33%)  3/7 (42.86%)  1/6 (16.67%)  3/6 (50.00%)  3/6 (50.00%)  0/7 (0.00%)  1/18 (5.56%) 
Uterine pain  1  0/6 (0.00%)  1/7 (14.29%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/18 (0.00%) 
Vaginal discharge  1  0/6 (0.00%)  1/7 (14.29%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%)  0/18 (0.00%) 
Vaginal dryness  1  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/7 (14.29%)  0/18 (0.00%) 
Vaginal pain  1  0/6 (0.00%)  1/7 (14.29%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/18 (0.00%) 
Respiratory, thoracic and mediastinal disorders               
Allergic rhinitis  1  3/6 (50.00%)  2/7 (28.57%)  6/6 (100.00%)  3/6 (50.00%)  3/6 (50.00%)  3/7 (42.86%)  0/18 (0.00%) 
Bronchospasm  1  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/18 (0.00%) 
Cough  1  3/6 (50.00%)  0/7 (0.00%)  2/6 (33.33%)  2/6 (33.33%)  1/6 (16.67%)  1/7 (14.29%)  0/18 (0.00%) 
Dyspnea  1  1/6 (16.67%)  1/7 (14.29%)  3/6 (50.00%)  1/6 (16.67%)  0/6 (0.00%)  1/7 (14.29%)  0/18 (0.00%) 
Laryngeal mucositis  1  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/7 (14.29%)  0/18 (0.00%) 
Pharyngolaryngeal pain  1  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/7 (28.57%)  0/18 (0.00%) 
Respiratory, thoracic and mediastinal disorders: dyspnea on exertion  1  0/6 (0.00%)  1/7 (14.29%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/18 (0.00%) 
Sinus disorder  1  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  0/7 (0.00%)  0/18 (0.00%) 
Voice alteration  1  0/6 (0.00%)  1/7 (14.29%)  2/6 (33.33%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%)  0/18 (0.00%) 
Skin and subcutaneous tissue disorders               
Alopecia  1  5/6 (83.33%)  5/7 (71.43%)  2/6 (33.33%)  2/6 (33.33%)  5/6 (83.33%)  2/7 (28.57%)  0/18 (0.00%) 
Dry skin  1  0/6 (0.00%)  1/7 (14.29%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/7 (14.29%)  0/18 (0.00%) 
Hyperhidrosis  1  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  0/7 (0.00%)  0/18 (0.00%) 
Nail loss  1  1/6 (16.67%)  0/7 (0.00%)  2/6 (33.33%)  0/6 (0.00%)  1/6 (16.67%)  3/7 (42.86%)  0/18 (0.00%) 
Palmar-plantar erythrodysesthesia syndrome  1  0/6 (0.00%)  1/7 (14.29%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/18 (0.00%) 
Pruritus  1  3/6 (50.00%)  1/7 (14.29%)  1/6 (16.67%)  1/6 (16.67%)  0/6 (0.00%)  1/7 (14.29%)  0/18 (0.00%) 
Purpura  1  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%)  0/18 (0.00%) 
Rash acneiform  1  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/18 (0.00%) 
Rash maculo-papular  1  0/6 (0.00%)  1/7 (14.29%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%)  0/18 (0.00%) 
Skin and subcutaneous tissue disorders: nose sores  1  0/6 (0.00%)  0/7 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/18 (0.00%) 
Skin ulceration  1  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/18 (0.00%) 
Vascular disorders               
Flushing  1  0/6 (0.00%)  1/7 (14.29%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/18 (0.00%) 
Hematoma  1  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/18 (0.00%) 
Hot flashes  1  2/6 (33.33%)  3/7 (42.86%)  3/6 (50.00%)  1/6 (16.67%)  2/6 (33.33%)  3/7 (42.86%)  0/18 (0.00%) 
Hypertension  1  1/6 (16.67%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/7 (14.29%)  0/18 (0.00%) 
Vascular disorders: easy bruising  1  0/6 (0.00%)  0/7 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/18 (0.00%) 
Vascular disorders: epitaxsis  1  0/6 (0.00%)  1/7 (14.29%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/18 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
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: P. Kelly Marcom, M.D.
Organization: Duke University Medical Center
Phone: 919-684-3877
EMail: marco001@mc.duke.edu
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00636441    
Other Study ID Numbers: Pro00001345
W81XWH-07-1-0394
BC060228-W81XWH-07-1-0394
First Submitted: March 9, 2008
First Posted: March 14, 2008
Results First Submitted: May 7, 2014
Results First Posted: October 7, 2014
Last Update Posted: December 11, 2015