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Studying Blood Samples From Women With Breast Cancer or Ductal Carcinoma In Situ Who Are Receiving Tamoxifen (NRR)

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ClinicalTrials.gov Identifier: NCT00764322
Recruitment Status : Completed
First Posted : October 2, 2008
Results First Posted : July 2, 2017
Last Update Posted : August 1, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Breast Cancer
Menopausal Symptoms
Interventions Drug: tamoxifen citrate
Genetic: gene expression analysis
Other: pharmacogenomic studies
Other: questionnaire administration
Procedure: quality-of-life assessment
Enrollment 501
Recruitment Details Participants were recruited from breast cancer patients at Lineberger Comprehensive Cancer Center who had received tamoxifen for at least 4 months.
Pre-assignment Details One patient was a screen failure
Arm/Group Title Patients Enrolled
Hide Arm/Group Description [Not Specified]
Period Title: Overall Study
Started 500
Completed 480
Not Completed 20
Reason Not Completed
Withdrawal by Subject             11
No CYP2D6 genotyping             9
Arm/Group Title Extensive and Ultra-rapid Metabolizers Intermediate and Poor Metabolizers Total
Hide Arm/Group Description Those with the highest endoxifen concentrations as measured at baseline. Genotype-guided escalation of the tamoxifen dose from 20mg to 40mg/day. Total of all reporting groups
Overall Number of Baseline Participants 161 319 480
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Median Number Analyzed 161 participants 319 participants 480 participants
51
(30 to 95)
50
(25 to 88)
50
(25 to 95)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 161 participants 319 participants 480 participants
Female
161
 100.0%
319
 100.0%
480
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 161 participants 319 participants 480 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
13
   8.1%
61
  19.1%
74
  15.4%
White
140
  87.0%
250
  78.4%
390
  81.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
8
   5.0%
8
   2.5%
16
   3.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 161 participants 319 participants 480 participants
161
 100.0%
319
 100.0%
480
 100.0%
Menopausal status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 161 participants 319 participants 480 participants
Pre/peri-
70
  43.5%
154
  48.3%
224
  46.7%
Post-
91
  56.5%
165
  51.7%
256
  53.3%
Duration of Tamoxifen treatment (years)  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 161 participants 319 participants 480 participants
0.88
(0.31 to 9.69)
0.98
(0.28 to 15.86)
0.93
(0.28 to 15.86)
Prior chemotherapy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 161 participants 319 participants 480 participants
Yes
92
  57.1%
169
  53.0%
261
  54.4%
No
69
  42.9%
150
  47.0%
219
  45.6%
Tamoxifen indication   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 161 participants 318 participants 479 participants
Invasive Disease
144
  89.4%
263
  82.7%
407
  85.0%
DCIS
17
  10.6%
49
  15.4%
66
  13.8%
Other
0
   0.0%
6
   1.9%
6
   1.3%
[1]
Measure Analysis Population Description: One patient could not be included because indication was not supplied.
1.Primary Outcome
Title Endoxifen Concentrations in Participants Receiving Tamoxifen Citrate Dose of 20 mg or 40 mg Stratified by the Metabolizing CYP2D6 Genotypes
Hide Description Measurements of plasma concentrations of the key active metabolite of tamoxifen, endoxifen, were measured at baseline and after 4 months of treatment; The most common CYP2D6 alleles have been grouped by functional activity classifications with descending activity: ultra-rapid (UM), extensive (EM), intermediate (IM) or poor (PM) metabolism. A given patient has two alleles, giving them 10 possible allelic combinations, or diplotypes (UM/UM, UM/EM, EM/EM, etc.). These diplotypes are collapsed into four phenotypes, UM, EM, IM or PM.
Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
Baseline measurements are reported on all 353 subjects, while the 4 month levels are reported only for patients who completed 4 months of treatment
Arm/Group Title Ultra-rapid Metabolizers Extensive Metabolizers Intermediate Metabolizers Poor Metabolizers
Hide Arm/Group Description:
Those with the highest transformation of the CYP2D6 genotype to allelic activity
Those with the most normal transformation of the CYP2D6 genotype to allelic activity
Those with reduced transformation of the CYP2D6 genotype to allelic activity Genotype-guided escalation of the tamoxifen dose from 20mg to 40mg/day.
Those with no transformation of the CYP2D6 genotype to allelic activity Genotype-guided escalation of the tamoxifen dose from 20mg to 40mg/day.
Overall Number of Participants Analyzed 5 119 212 17
Mean (Standard Deviation)
Unit of Measure: ng/mL
Baseline endoxifen concentration Number Analyzed 5 participants 119 participants 212 participants 17 participants
8.4  (4.59) 10.00  (6.00) 7.10  (4.77) 3.42  (2.75)
4-Month endoxifen concentration Number Analyzed 4 participants 106 participants 179 participants 13 participants
15.35  (5.48) 9.30  (5.03) 10.74  (7.36) 5.52  (2.57)
2.Secondary Outcome
Title Number of Participants With Pulmonary Embolism (PE), Deep Vein Thrombosis (DVT), Stroke, and/or Endometrial Cancer
Hide Description The doubling of tamoxifen dose is defined as "unacceptable" (i.e., not tolerable) if the prevalence of Pulmonary embolism (PE), Deep vein thrombosis (DVT), stroke, or endometrial cancer, either individually or in any combination, is greater than 2%.
Time Frame Approximately ten months from registration to last follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Incidence of unacceptable adverse events among all patients who completed study
Arm/Group Title Tamoxifen 20 Tamoxifen 40
Hide Arm/Group Description:

One arm, containing the ultra-rapid and extensive metabolizer genotypes, continues treatment with tamoxifen at 20mg.

tamoxifen citrate: Women found to be IM or PM will undergo increased tamoxifen to 40 mg/day (20 mg bid). Drug is given orally on a daily basis.

gene expression analysis: Genetic analysis of blood sample.

pharmacogenomic studies: Genetic analysis of blood sample.

questionnaire administration: Questionnaire called the survey of participants. Questionnaires is self administered on paper documents and given pre-study, and at 4 months

quality-of-life assessment: Self administration of a multiquestion questionnaire called the Functional Assessment of Cancer Therapy -Breast (FACT-B). Given pre-study, at 4 months and at 8-10 months.

This arm, containing the intermediate and poor metabolizer genotypes, receives escalated treatment with tamoxifen at 40mg.

tamoxifen citrate: Women found to be IM or PM will undergo increased tamoxifen to 40 mg/day (20 mg bid). Drug is given orally on a daily basis.

gene expression analysis: Genetic analysis of blood sample.

pharmacogenomic studies: Genetic analysis of blood sample.

questionnaire administration: Questionnaire called the survey of participants. Questionnaires is self administered on paper documents and given pre-study, and at 4 months

quality-of-life assessment: Self administration of a multiquestion questionnaire called the Functional Assessment of Cancer Therapy -Breast (FACT-B). Given pre-study, at 4 months and at 8-10 months.

Overall Number of Participants Analyzed 161 319
Measure Type: Count of Participants
Unit of Measure: Participants
Pulmonary embolism (PE) 0 0
Deep vein thrombosis (DVT) 0 0
Stroke 0 0
Endometrial cancer 0 0
3.Secondary Outcome
Title Change in Median Endoxifen Concentrations to Determine Feasibility of Obtaining Pharmacogenomic Information From Patients in the Clinical Setting and Using it to Guide Changes in Therapy
Hide Description If the key active tamoxifen metabolite, endoxifen, could be significantly increased by genotype-guided tamoxifen dosing in patients with intermediate CYP2D6 metabolism (by increasing tamoxifen dosing based on CYP2D6 genotype), then the study would be deemed feasible and the accrual expanded.
Time Frame Baseline and 4 months after dose increase
Hide Outcome Measure Data
Hide Analysis Population Description
This was based on the initial 119 subjects enrolled (based on initial sample size of 100) and of those, the 89 that completed 4 months of tamoxifen therapy
Arm/Group Title Extensive Metabolizers Intermediate Metabolizers Poor Metabolizers
Hide Arm/Group Description:
Those with the highest endoxifen concentrations as measured at baseline.
Genotype-guided escalation of the tamoxifen dose from 20mg to 40mg/day.
Genotype-guided escalation of the tamoxifen dose from 20mg to 40mg/day.
Overall Number of Participants Analyzed 29 51 9
Median (Inter-Quartile Range)
Unit of Measure: ng/mL
-1.5
(-28 to 11.2)
7.6
(-0.6 to 23.9)
6.1
(2.6 to 12.5)
4.Secondary Outcome
Title CYP2D6 Allele Frequencies and Endoxifen Levels Among African-American Women Taking Tamoxifen Citrate
Hide Description Mean endoxifen levels by CYP2D6 genotype among African Americans. Measurements of plasma concentrations of the key active metabolite of tamoxifen, endoxifen, were measured at baseline.The most common CYP2D6 alleles have been grouped by functional activity classifications with descending activity: ultra-rapid (UM), extensive (EM), intermediate (IM) or poor (PM) metabolism. A given patient has two alleles, giving them 10 possible allelic combinations, or diplotypes (UM/UM, UM/EM, EM/EM, etc.). These diplotypes are collapsed into four phenotypes, UM, EM, IM or PM.
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants who self-identified as African American were included in this analysis
Arm/Group Title African Americans
Hide Arm/Group Description:
Participants who self identified as African American Race
Overall Number of Participants Analyzed 52
Mean (Full Range)
Unit of Measure: ng/ml
UM Number Analyzed 1 participants
14.58
(14.58 to 14.58)
EM Number Analyzed 8 participants
9.69
(1.08 to 21.98)
IM Number Analyzed 42 participants
7.09
(1.07 to 20.89)
PM Number Analyzed 1 participants
0.8
(0.8 to 0.8)
5.Secondary Outcome
Title Change in Plasma Endoxifen Levels After an Increase in Tamoxifen Citrate Dose From 20 mg to 40 mg Daily in Patients With Poor-metabolizing Genotypes
Hide Description The intrapatient change in median endoxifen levels were calculated between baseline and 4 months after the increase in dose of Tamoxifen from 20mg/day to 40 mg/day
Time Frame Baseline and 4 months after dose increase
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis limited to only those subjects with the Poor Metabolizing (PM) genotype who were evaluable at baseline
Arm/Group Title Poor Metabolizers
Hide Arm/Group Description:
Those with no transformation of the CYP2D6 genotype to allelic activity Genotype-guided escalation of the tamoxifen dose from 20mg to 40mg/day.
Overall Number of Participants Analyzed 11
Median (Inter-Quartile Range)
Unit of Measure: ng/mL
6.1
(2.6 to 12.5)
6.Secondary Outcome
Title Patient Understanding of Pharmacogenomics
Hide Description To examine patients' beliefs about how hypothetical genotype information would affect their perceived recurrence risk and benefits of tamoxifen therapy, participants were given experimentally manipulated 6 vignettes to describe hypothetical tamoxifen treatment (no or yes) and hypothetical genotype (EM, IM or PM). For each vignette, participants gave their perceived recurrence risk (RR; 0-100%)
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Of 377 patients who were eligible to complete the survey, 320 patients completed the survey and 57 returned incomplete surveys
Arm/Group Title All Participants
Hide Arm/Group Description:
All participants in the main study who consented to this additional survey
Overall Number of Participants Analyzed 320
Mean (Full Range)
Unit of Measure: percent chance of recurrence
Perceived RR -No tamoxifen/EM
47
(0 to 100)
Perceived RR -No tamoxifen/iM
48
(0 to 100)
Perceived RR -No tamoxifen/PM
53
(0 to 100)
Perceived RR - tamoxifen/EM
22
(0 to 100)
Perceived RR -tamoxifen/IM
30
(0 to 100)
Perceived RR -tamoxifen/PM
40
(0 to 100)
Time Frame Approximately ten months from on-study to last follow-up visit
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ultra-rapid and Extensive Metabolizers Intermediate Metabolizers Poor Metabolizers
Hide Arm/Group Description Those with the highest endoxifen concentrations as measured at baseline. Genotype-guided escalation of the tamoxifen dose from 20mg to 40mg/day. Genotype-guided escalation of the tamoxifen dose from 20mg to 40mg/day.
All-Cause Mortality
Ultra-rapid and Extensive Metabolizers Intermediate Metabolizers Poor Metabolizers
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/161 (0.00%)      0/290 (0.00%)      0/29 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Ultra-rapid and Extensive Metabolizers Intermediate Metabolizers Poor Metabolizers
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/161 (0.00%)      3/290 (1.03%)      0/29 (0.00%)    
Nervous system disorders       
headache * 2  0/161 (0.00%)  0 1/290 (0.34%)  1 0/29 (0.00%)  0
Psychiatric disorders       
Mood alteration  2 [1]  0/161 (0.00%)  0 1/290 (0.34%)  1 0/29 (0.00%)  0
Reproductive system and breast disorders       
Hemorrhage, GU  1  0/161 (0.00%)  0 1/290 (0.34%)  1 0/29 (0.00%)  0
Vascular disorders       
thrombosis * 2 [2]  0/161 (0.00%)  0 1/290 (0.34%)  1 0/29 (0.00%)  0
1
Term from vocabulary, ctcae 3
2
Term from vocabulary, CTCAE (3.0)
*
Indicates events were collected by non-systematic assessment
Indicates events were collected by systematic assessment
[1]
Depression
[2]
thrombosis, vascular access related
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Ultra-rapid and Extensive Metabolizers Intermediate Metabolizers Poor Metabolizers
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   149/161 (92.55%)      274/290 (94.48%)      26/29 (89.66%)    
Blood and lymphatic system disorders       
Hemorrhage, GU - Vagina * 1  0/161 (0.00%)  4/290 (1.38%)  2/29 (6.90%) 
Hemorrhage/Bleeding - Other (Specify, __) * 1 [1]  3/161 (1.86%)  2/290 (0.69%)  0/29 (0.00%) 
Cardiac disorders       
Palpitations * 1  4/161 (2.48%)  5/290 (1.72%)  0/29 (0.00%) 
Eye disorders       
Cataract * 1  3/161 (1.86%)  8/290 (2.76%)  0/29 (0.00%) 
Ocular/Visual - Other (Specify, __) * 1  2/161 (1.24%)  2/290 (0.69%)  0/29 (0.00%) 
Vision-blurred vision * 1  8/161 (4.97%)  21/290 (7.24%)  0/29 (0.00%) 
Gastrointestinal disorders       
Constipation * 1  8/161 (4.97%)  18/290 (6.21%)  0/29 (0.00%) 
Diarrhea * 1  5/161 (3.11%)  9/290 (3.10%)  2/29 (6.90%) 
Distension/bloating, abdominal * 1  5/161 (3.11%)  9/290 (3.10%)  0/29 (0.00%) 
Gastrointestinal - Other (Specify, __) * 1 [2]  2/161 (1.24%)  6/290 (2.07%)  0/29 (0.00%) 
Heartburn/dyspepsia * 1  5/161 (3.11%)  10/290 (3.45%)  0/29 (0.00%) 
Hemorrhoids * 1  2/161 (1.24%)  4/290 (1.38%)  0/29 (0.00%) 
Nausea * 1  6/161 (3.73%)  18/290 (6.21%)  0/29 (0.00%) 
Pain - Abdomen NOS * 1  5/161 (3.11%)  6/290 (2.07%)  0/29 (0.00%) 
General disorders       
Edema: limb * 1  10/161 (6.21%)  19/290 (6.55%)  0/29 (0.00%) 
Fatigue (asthenia, lethargy, malaise) * 1  42/161 (26.09%)  64/290 (22.07%)  5/29 (17.24%) 
Pain - Other (Specify, __) * 1  4/161 (2.48%)  6/290 (2.07%)  0/29 (0.00%) 
Immune system disorders       
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) * 1  4/161 (2.48%)  11/290 (3.79%)  0/29 (0.00%) 
Infections and infestations       
Infection with unknown ANC * 1  0/161 (0.00%)  9/290 (3.10%)  0/29 (0.00%) 
Injury, poisoning and procedural complications       
Bruising (in absence of Grade 3 or 4 thrombocytopenia) * 1  4/161 (2.48%)  6/290 (2.07%)  0/29 (0.00%) 
Investigations       
ALT, SGPT (serum glutamic pyruvic transaminase) * 1  3/161 (1.86%)  3/290 (1.03%)  0/29 (0.00%) 
AST, SGOT(serum glutamic oxaloacetic transaminase) * 1  5/161 (3.11%)  3/290 (1.03%)  0/29 (0.00%) 
Weight gain * 1  14/161 (8.70%)  33/290 (11.38%)  4/29 (13.79%) 
Musculoskeletal and connective tissue disorders       
Arthritis (non-septic) * 1  0/161 (0.00%)  5/290 (1.72%)  0/29 (0.00%) 
Joint - Function * 1  2/161 (1.24%)  7/290 (2.41%)  0/29 (0.00%) 
Musculoskeletal/Soft Tissue - Other (Specify, __) * 1 [3]  5/161 (3.11%)  11/290 (3.79%)  0/29 (0.00%) 
Osteoporosis * 1  0/161 (0.00%)  3/290 (1.03%)  0/29 (0.00%) 
Pain - Back * 1  15/161 (9.32%)  28/290 (9.66%)  2/29 (6.90%) 
Pain - Bone * 1  4/161 (2.48%)  11/290 (3.79%)  0/29 (0.00%) 
Pain - Breast * 1  13/161 (8.07%)  22/290 (7.59%)  0/29 (0.00%) 
Pain - Buttock * 1  3/161 (1.86%)  2/290 (0.69%)  0/29 (0.00%) 
Pain - Extremity-limb * 1  16/161 (9.94%)  14/290 (4.83%)  3/29 (10.34%) 
Pain - Joint * 1  40/161 (24.84%)  58/290 (20.00%)  5/29 (17.24%) 
Pain - Muscle * 1  15/161 (9.32%)  38/290 (13.10%)  2/29 (6.90%) 
Pain - Neck * 1  0/161 (0.00%)  5/290 (1.72%)  0/29 (0.00%) 
Nervous system disorders       
Cognitive disturbance * 1  13/161 (8.07%)  27/290 (9.31%)  3/29 (10.34%) 
Dizziness * 1  5/161 (3.11%)  14/290 (4.83%)  3/29 (10.34%) 
Memory impairment * 1  6/161 (3.73%)  16/290 (5.52%)  0/29 (0.00%) 
Neurology - Other (Specify, __) * 1 [4]  0/161 (0.00%)  7/290 (2.41%)  0/29 (0.00%) 
Neuropathy- sensory * 1  15/161 (9.32%)  22/290 (7.59%)  0/29 (0.00%) 
Pain - Head/headache * 1  15/161 (9.32%)  42/290 (14.48%)  4/29 (13.79%) 
Psychiatric disorders       
Insomnia * 1  26/161 (16.15%)  42/290 (14.48%)  4/29 (13.79%) 
Mood alteration * 1  2/161 (1.24%)  4/290 (1.38%)  0/29 (0.00%) 
Mood alteration - Agitation * 1  5/161 (3.11%)  9/290 (3.10%)  4/29 (13.79%) 
Mood alteration - Anxiety * 1  20/161 (12.42%)  17/290 (5.86%)  0/29 (0.00%) 
Mood alteration - Depression * 1  14/161 (8.70%)  13/290 (4.48%)  2/29 (6.90%) 
Renal and urinary disorders       
Incontinence, urinary * 1  13/161 (8.07%)  28/290 (9.66%)  3/29 (10.34%) 
Urinary frequency/urgency * 1  4/161 (2.48%)  2/290 (0.69%)  0/29 (0.00%) 
Reproductive system and breast disorders       
Irregular menses (change from baseline) * 1  9/161 (5.59%)  14/290 (4.83%)  0/29 (0.00%) 
Libido * 1  16/161 (9.94%)  24/290 (8.28%)  3/29 (10.34%) 
Sexual/Reproductive Function - Other (Specify, __) * 1  9/161 (5.59%)  17/290 (5.86%)  0/29 (0.00%) 
Vaginal discharge (non-infectious) * 1  20/161 (12.42%)  44/290 (15.17%)  2/29 (6.90%) 
Vaginal dryness * 1  32/161 (19.88%)  66/290 (22.76%)  8/29 (27.59%) 
Vaginitis * 1  3/161 (1.86%)  3/290 (1.03%)  0/29 (0.00%) 
Vaginitis (not due to infection) * 1  0/161 (0.00%)  4/290 (1.38%)  0/29 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough * 1  10/161 (6.21%)  12/290 (4.14%)  0/29 (0.00%) 
Dyspnea * 1  11/161 (6.83%)  15/290 (5.17%)  0/29 (0.00%) 
Nasal cavity/paranasal sinus reactions * 1  2/161 (1.24%)  4/290 (1.38%)  0/29 (0.00%) 
Pain - Chest/thorax NOS * 1  4/161 (2.48%)  2/290 (0.69%)  0/29 (0.00%) 
Pulmonary/Upper Respiratory - Other (Specify, __) * 1  4/161 (2.48%)  4/290 (1.38%)  0/29 (0.00%) 
Skin and subcutaneous tissue disorders       
Hair loss/alopecia (scalp or body) * 1  8/161 (4.97%)  17/290 (5.86%)  0/29 (0.00%) 
Nail changes * 1  1/161 (0.62%)  7/290 (2.41%)  0/29 (0.00%) 
Pruritus/itching * 1  4/161 (2.48%)  3/290 (1.03%)  0/29 (0.00%) 
Rash/desquamation * 1  4/161 (2.48%)  6/290 (2.07%)  0/29 (0.00%) 
Rash: acne/acneiform * 1  2/161 (1.24%)  6/290 (2.07%)  2/29 (6.90%) 
Sweating (diaphoresis) * 1  6/161 (3.73%)  12/290 (4.14%)  0/29 (0.00%) 
Vascular disorders       
Hot flashes/flushes * 1  124/161 (77.02%)  230/290 (79.31%)  23/29 (79.31%) 
Hypertension * 1  3/161 (1.86%)  11/290 (3.79%)  0/29 (0.00%) 
Lymphedema-related fibrosis * 1  0/161 (0.00%)  5/290 (1.72%)  0/29 (0.00%) 
1
Term from vocabulary, CTCAE (3.0)
*
Indicates events were collected by non-systematic assessment
[1]
Verbatim: Blood flecking in stools; epistaxis; hematemisis; nose hemorrhage; bloodshot eyes
[2]
Verbatim: Mouth problems; dry mouth; dysphagia with regurgitation, requiring dilation; gastroparesis; taste alteration; anorexia; gastric dumping syndrome; teeth sensitivities
[3]
Verbatim: broken wrist; feet stiff; weakness; avascular necrosis; leg cramps; difficulty walking; fractured vertebrae; joint difficulties right thumb; osteopenia; pulled back; rotator cuff tear; tennis elbow; fractured elbow; stiffness
[4]
Verbatim: hallucinations at night; seizures; felt drunk; claustrophobia; feeling weird; handwriting worsened, near syncope
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
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Name/Title: Robin V. Johnson
Organization: UNC Lineberger Comprehensive Cancer Center
Phone: 919-966-1125
EMail: Robin_V_Johnson@med.unc.edu
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Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00764322     History of Changes
Other Study ID Numbers: LCCC 0801
P30CA016086 ( U.S. NIH Grant/Contract )
08-0483 ( Other Identifier: UNC Biomedical IRB )
First Submitted: October 1, 2008
First Posted: October 2, 2008
Results First Submitted: March 31, 2017
Results First Posted: July 2, 2017
Last Update Posted: August 1, 2017