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Trastuzumab in Treating Older Women With Early-Stage Breast Cancer

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ClinicalTrials.gov Identifier: NCT00796978
Recruitment Status : Completed
First Posted : November 24, 2008
Results First Posted : August 3, 2020
Last Update Posted : August 3, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Cynthia Owusu, MD, Case Comprehensive Cancer Center

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Biological: trastuzumab
Other: laboratory biomarker analysis
Procedure: adjuvant therapy
Procedure: quality-of-life assessment
Enrollment 56
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Trastuzumab
Hide Arm/Group Description

trastuzumab: Trastuzumab (Herceptin®) IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.

laboratory biomarker analysis: Blood is collected every 6 weeks during treatment. Samples are assessed for plasma cardiac markers (N-terminal brain natriuretic protein and troponin-I) and pro-inflammatory cytokines (interleukin-6 and tumor necrosis factor-α).

adjuvant therapy: Patients receive trastuzumab (Herceptin®) IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.

quality-of-life assessment: Patients complete Quality of Life and Quality of Health and Comprehensive Geriatric assessments of functional, cognitive, and mental status changes at baseline, weeks 26, and 52.

Period Title: Overall Study
Started 56
Completed 44
Not Completed 12
Reason Not Completed
Cardiac adverse event             5
Adverse Event             4
Withdrawal by Subject             3
Arm/Group Title Trastuzumab
Hide Arm/Group Description

trastuzumab: Trastuzumab (Herceptin®) IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.

laboratory biomarker analysis: Blood is collected every 6 weeks during treatment. Samples are assessed for plasma cardiac markers (N-terminal brain natriuretic protein and troponin-I) and pro-inflammatory cytokines (interleukin-6 and tumor necrosis factor-α).

adjuvant therapy: Patients receive trastuzumab (Herceptin®) IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.

quality-of-life assessment: Patients complete Quality of Life and Quality of Health and Comprehensive Geriatric assessments of functional, cognitive, and mental status changes at baseline, weeks 26, and 52.

Overall Number of Baseline Participants 56
Hide Baseline Analysis Population Description
All participants who went on study
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
years Number Analyzed 56 participants
60-69
19
  33.9%
70-79
23
  41.1%
80-89
13
  23.2%
90-99
1
   1.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants
Female
56
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants
Hispanic or Latino
1
   1.8%
Not Hispanic or Latino
55
  98.2%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
7
  12.5%
White
49
  87.5%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 56 participants
56
1.Primary Outcome
Title Percent of Participants Experiencing Cardiac Events at 1 Year
Hide Description Number of participants that experience cardiac events that include cardiac death due to congestive heart failure (CHF), Myocardial infarction (MI) or documented arrhythmia, death without definitive cause, or signs and symptoms of CHF as defined by New York Heart Association (NYHA) class III or IV symptoms.
Time Frame At 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects that received treatment. All related outcomes occurred within 1 year, therefore, 3-year and 5-year cumulative incidences of cardiac events and asymptomatic LV cardiac dysfunction were not performed.
Arm/Group Title Trastuzumab
Hide Arm/Group Description:

trastuzumab: Trastuzumab (Herceptin®) IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.

laboratory biomarker analysis: Blood is collected every 6 weeks during treatment. Samples are assessed for plasma cardiac markers (N-terminal brain natriuretic protein and troponin-I) and pro-inflammatory cytokines (interleukin-6 and tumor necrosis factor-α).

adjuvant therapy: Patients receive trastuzumab (Herceptin®) IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.

quality-of-life assessment: Patients complete Quality of Life and Quality of Health and Comprehensive Geriatric assessments of functional, cognitive, and mental status changes at baseline, weeks 26, and 52.

Overall Number of Participants Analyzed 55
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
3.6
(0.09 to 13.8)
2.Secondary Outcome
Title Percent of Participants Experiencing Cardiac Events at 3 Years
Hide Description Number of participants that experience cardiac events that include cardiac death due to congestive heart failure (CHF), Myocardial infarction (MI) or documented arrhythmia, death without definitive cause, or signs and symptoms of CHF as defined by New York Heart Association (NYHA) class III or IV symptoms.
Time Frame At 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Data from 3-year and 5-year echocardiograms not collected, CI of cardiac events and asymptomatic LV cardiac dysfunction were not available
Arm/Group Title Trastuzumab
Hide Arm/Group Description:

trastuzumab: Trastuzumab (Herceptin®) IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.

laboratory biomarker analysis: Blood is collected every 6 weeks during treatment. Samples are assessed for plasma cardiac markers (N-terminal brain natriuretic protein and troponin-I) and pro-inflammatory cytokines (interleukin-6 and tumor necrosis factor-α).

adjuvant therapy: Patients receive trastuzumab (Herceptin®) IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.

quality-of-life assessment: Patients complete Quality of Life and Quality of Health and Comprehensive Geriatric assessments of functional, cognitive, and mental status changes at baseline, weeks 26, and 52.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Percent of Participants Experiencing Cardiac Events at 5 Years
Hide Description Number of participants that experience cardiac events that include cardiac death due to congestive heart failure (CHF), Myocardial infarction (MI) or documented arrhythmia, death without definitive cause, or signs and symptoms of CHF as defined by New York Heart Association (NYHA) class III or IV symptoms.
Time Frame At 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Data from 3-year and 5-year echocardiograms not collected, CI of cardiac events and asymptomatic LV cardiac dysfunction were not available
Arm/Group Title Trastuzumab
Hide Arm/Group Description:

trastuzumab: Trastuzumab (Herceptin®) IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.

laboratory biomarker analysis: Blood is collected every 6 weeks during treatment. Samples are assessed for plasma cardiac markers (N-terminal brain natriuretic protein and troponin-I) and pro-inflammatory cytokines (interleukin-6 and tumor necrosis factor-α).

adjuvant therapy: Patients receive trastuzumab (Herceptin®) IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.

quality-of-life assessment: Patients complete Quality of Life and Quality of Health and Comprehensive Geriatric assessments of functional, cognitive, and mental status changes at baseline, weeks 26, and 52.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Percent of Participants of Asymptomatic Left Ventricular (LV) Cardiac Dysfunction at 1 Year
Hide Description One-year cumulative incidence of LV cardiac dysfunction as measured by percent of participants that had asymptomatic LV cardiac dysfunction with/without permanent discontinuation
Time Frame At 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects that received treatment. All related outcomes occurred within 1 year, therefore, 3-year and 5-year cumulative incidences of cardiac events and asymptomatic LV cardiac dysfunction were not performed.
Arm/Group Title Trastuzumab
Hide Arm/Group Description:

trastuzumab: Trastuzumab (Herceptin®) IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.

laboratory biomarker analysis: Blood is collected every 6 weeks during treatment. Samples are assessed for plasma cardiac markers (N-terminal brain natriuretic protein and troponin-I) and pro-inflammatory cytokines (interleukin-6 and tumor necrosis factor-α).

adjuvant therapy: Patients receive trastuzumab (Herceptin®) IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.

quality-of-life assessment: Patients complete Quality of Life and Quality of Health and Comprehensive Geriatric assessments of functional, cognitive, and mental status changes at baseline, weeks 26, and 52.

Overall Number of Participants Analyzed 55
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent of participants
9.1
(3.9 to 20.1)
5.Secondary Outcome
Title Percent of Participants With Asymptomatic LV Cardiac Dysfunction at Three Years
Hide Description Three-year cumulative incidence of LV cardiac dysfunction as measured by percent of participants that had asymptomatic LV cardiac dysfunction with/without permanent discontinuation
Time Frame At 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Data from 3-year and 5-year echocardiograms not collected, CI of cardiac events and asymptomatic LV cardiac dysfunction were not available
Arm/Group Title Trastuzumab
Hide Arm/Group Description:

trastuzumab: Trastuzumab (Herceptin®) IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.

laboratory biomarker analysis: Blood is collected every 6 weeks during treatment. Samples are assessed for plasma cardiac markers (N-terminal brain natriuretic protein and troponin-I) and pro-inflammatory cytokines (interleukin-6 and tumor necrosis factor-α).

adjuvant therapy: Patients receive trastuzumab (Herceptin®) IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.

quality-of-life assessment: Patients complete Quality of Life and Quality of Health and Comprehensive Geriatric assessments of functional, cognitive, and mental status changes at baseline, weeks 26, and 52.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Percent of Participants With Asymptomatic LV Cardiac Dysfunction at Five Years
Hide Description Five-year cumulative incidence as measured by percent of participants that had asymptomatic LV cardiac dysfunction with/without permanent discontinuation
Time Frame At 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Data from 3-year and 5-year echocardiograms not collected, CI of cardiac events and asymptomatic LV cardiac dysfunction were not available
Arm/Group Title Trastuzumab
Hide Arm/Group Description:

trastuzumab: Trastuzumab (Herceptin®) IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.

laboratory biomarker analysis: Blood is collected every 6 weeks during treatment. Samples are assessed for plasma cardiac markers (N-terminal brain natriuretic protein and troponin-I) and pro-inflammatory cytokines (interleukin-6 and tumor necrosis factor-α).

adjuvant therapy: Patients receive trastuzumab (Herceptin®) IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.

quality-of-life assessment: Patients complete Quality of Life and Quality of Health and Comprehensive Geriatric assessments of functional, cognitive, and mental status changes at baseline, weeks 26, and 52.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Percent of Participants With Disease-free Survival (DFS)
Hide Description Percent of participants with DFS measured between the time from initiation of treatment to the date of first loco-regional or distant treatment failure, ignoring any intervening contralateral breast cancers or other second primary cancers. Deaths without evidence of recurrence will be treated censoring events.
Time Frame At 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that received treatment.
Arm/Group Title Trastuzumab
Hide Arm/Group Description:

trastuzumab: Trastuzumab (Herceptin®) IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.

laboratory biomarker analysis: Blood is collected every 6 weeks during treatment. Samples are assessed for plasma cardiac markers (N-terminal brain natriuretic protein and troponin-I) and pro-inflammatory cytokines (interleukin-6 and tumor necrosis factor-α).

adjuvant therapy: Patients receive trastuzumab (Herceptin®) IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.

quality-of-life assessment: Patients complete Quality of Life and Quality of Health and Comprehensive Geriatric assessments of functional, cognitive, and mental status changes at baseline, weeks 26, and 52.

Overall Number of Participants Analyzed 55
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percent of participants
96.36
(86.23 to 99.08)
8.Secondary Outcome
Title Percent of Participants With DFS
Hide Description Percent of participants with DFS measured between the time from initiation of treatment to the date of first loco-regional or distant treatment failure, ignoring any intervening contralateral breast cancers or other second primary cancers. Deaths without evidence of recurrence will be treated censoring events.
Time Frame At 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that received treatment.
Arm/Group Title Trastuzumab
Hide Arm/Group Description:

trastuzumab: Trastuzumab (Herceptin®) IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.

laboratory biomarker analysis: Blood is collected every 6 weeks during treatment. Samples are assessed for plasma cardiac markers (N-terminal brain natriuretic protein and troponin-I) and pro-inflammatory cytokines (interleukin-6 and tumor necrosis factor-α).

adjuvant therapy: Patients receive trastuzumab (Herceptin®) IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.

quality-of-life assessment: Patients complete Quality of Life and Quality of Health and Comprehensive Geriatric assessments of functional, cognitive, and mental status changes at baseline, weeks 26, and 52.

Overall Number of Participants Analyzed 55
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
94.47
(83.83 to 98.18)
9.Secondary Outcome
Title Percent of Participants With Disease-free Survival (DFS)
Hide Description Percent of participants with DFS measured between the time from initiation of treatment to the date of first loco-regional or distant treatment failure, ignoring any intervening contralateral breast cancers or other second primary cancers. Deaths without evidence of recurrence will be treated censoring events.
Time Frame At 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that received treatment.
Arm/Group Title Trastuzumab
Hide Arm/Group Description:

trastuzumab: Trastuzumab (Herceptin®) IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.

laboratory biomarker analysis: Blood is collected every 6 weeks during treatment. Samples are assessed for plasma cardiac markers (N-terminal brain natriuretic protein and troponin-I) and pro-inflammatory cytokines (interleukin-6 and tumor necrosis factor-α).

adjuvant therapy: Patients receive trastuzumab (Herceptin®) IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.

quality-of-life assessment: Patients complete Quality of Life and Quality of Health and Comprehensive Geriatric assessments of functional, cognitive, and mental status changes at baseline, weeks 26, and 52.

Overall Number of Participants Analyzed 55
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
92.46
(81.13 to 97.11)
10.Secondary Outcome
Title Percent of Participants With Disease-free Survival (DFS)
Hide Description Percent of participants with DFS measured between the time from initiation of treatment to the date of first loco-regional or distant treatment failure, ignoring any intervening contralateral breast cancers or other second primary cancers. Deaths without evidence of recurrence will be treated censoring events.
Time Frame At 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that received treatment.
Arm/Group Title Trastuzumab
Hide Arm/Group Description:

trastuzumab: Trastuzumab (Herceptin®) IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.

laboratory biomarker analysis: Blood is collected every 6 weeks during treatment. Samples are assessed for plasma cardiac markers (N-terminal brain natriuretic protein and troponin-I) and pro-inflammatory cytokines (interleukin-6 and tumor necrosis factor-α).

adjuvant therapy: Patients receive trastuzumab (Herceptin®) IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.

quality-of-life assessment: Patients complete Quality of Life and Quality of Health and Comprehensive Geriatric assessments of functional, cognitive, and mental status changes at baseline, weeks 26, and 52.

Overall Number of Participants Analyzed 55
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
86.4
(73.59 to 93.30)
11.Secondary Outcome
Title Overall Survival (OS) as Measured by Percent of Participants Alive at 1 Year
Hide Description OS defined as percent of participants alive between time from initiation of treatment to the date of protocol-defined outcome from any cause and censored to the date of last follow-up for survivors.
Time Frame Up to 1 years
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that received treatment.
Arm/Group Title Trastuzumab
Hide Arm/Group Description:

trastuzumab: Trastuzumab (Herceptin®) IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.

laboratory biomarker analysis: Blood is collected every 6 weeks during treatment. Samples are assessed for plasma cardiac markers (N-terminal brain natriuretic protein and troponin-I) and pro-inflammatory cytokines (interleukin-6 and tumor necrosis factor-α).

adjuvant therapy: Patients receive trastuzumab (Herceptin®) IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.

quality-of-life assessment: Patients complete Quality of Life and Quality of Health and Comprehensive Geriatric assessments of functional, cognitive, and mental status changes at baseline, weeks 26, and 52.

Overall Number of Participants Analyzed 55
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent of participants
100.0
(100.0 to 100.0)
12.Secondary Outcome
Title Overall Survival (OS) as Measured by Percent of Participants Alive at 2 Years
Hide Description OS defined as percent of participants alive between time from initiation of treatment to the date of protocol-defined outcome from any cause and censored to the date of last follow-up for survivors.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that received treatment.
Arm/Group Title Trastuzumab
Hide Arm/Group Description:

trastuzumab: Trastuzumab (Herceptin®) IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.

laboratory biomarker analysis: Blood is collected every 6 weeks during treatment. Samples are assessed for plasma cardiac markers (N-terminal brain natriuretic protein and troponin-I) and pro-inflammatory cytokines (interleukin-6 and tumor necrosis factor-α).

adjuvant therapy: Patients receive trastuzumab (Herceptin®) IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.

quality-of-life assessment: Patients complete Quality of Life and Quality of Health and Comprehensive Geriatric assessments of functional, cognitive, and mental status changes at baseline, weeks 26, and 52.

Overall Number of Participants Analyzed 55
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent of participants
100.0
(100.0 to 100.0)
13.Secondary Outcome
Title Overall Survival (OS) as Measured by Percent of Participants Alive at 3 Years
Hide Description OS defined as percent of participants alive between time from initiation of treatment to the date of protocol-defined outcome from any cause and censored to the date of last follow-up for survivors.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that received treatment.
Arm/Group Title Trastuzumab
Hide Arm/Group Description:

trastuzumab: Trastuzumab (Herceptin®) IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.

laboratory biomarker analysis: Blood is collected every 6 weeks during treatment. Samples are assessed for plasma cardiac markers (N-terminal brain natriuretic protein and troponin-I) and pro-inflammatory cytokines (interleukin-6 and tumor necrosis factor-α).

adjuvant therapy: Patients receive trastuzumab (Herceptin®) IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.

quality-of-life assessment: Patients complete Quality of Life and Quality of Health and Comprehensive Geriatric assessments of functional, cognitive, and mental status changes at baseline, weeks 26, and 52.

Overall Number of Participants Analyzed 55
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent of participants
94.23
(83.17 to 98.10)
14.Secondary Outcome
Title Overall Survival (OS) as Measured by Percent of Participants Alive at 5 Years
Hide Description OS defined as percent of participants alive between time from initiation of treatment to the date of protocol-defined outcome from any cause and censored to the date of last follow-up for survivors.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that received treatment.
Arm/Group Title Trastuzumab
Hide Arm/Group Description:

trastuzumab: Trastuzumab (Herceptin®) IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.

laboratory biomarker analysis: Blood is collected every 6 weeks during treatment. Samples are assessed for plasma cardiac markers (N-terminal brain natriuretic protein and troponin-I) and pro-inflammatory cytokines (interleukin-6 and tumor necrosis factor-α).

adjuvant therapy: Patients receive trastuzumab (Herceptin®) IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.

quality-of-life assessment: Patients complete Quality of Life and Quality of Health and Comprehensive Geriatric assessments of functional, cognitive, and mental status changes at baseline, weeks 26, and 52.

Overall Number of Participants Analyzed 55
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent of participants
90.2
(79.91 to 97.70)
15.Secondary Outcome
Title Mean Change in Quality of Life and Comprehensive Geriatric Assessment Scores From Baseline to Mid-treatment and Baseline to End of Treatment
Hide Description [Not Specified]
Time Frame Baseline to week 26 and baseline to 52 weeks after being on study
Outcome Measure Data Not Reported
16.Other Pre-specified Outcome
Title Mean Change in Pro-inflammatory Cytokines From Baseline to Mid-treatment and Baseline to End of Treatment
Hide Description [Not Specified]
Time Frame Every 6 weeks during treatment up to three years
Outcome Measure Data Not Reported
17.Other Pre-specified Outcome
Title Mean Change in Plasma Cardiac Markers From Baseline to Mid-treatment and Baseline to End of Treatment
Hide Description [Not Specified]
Time Frame Every 6 weeks during treatment up to three years
Outcome Measure Data Not Reported
Time Frame Adverse Event Data was collected up to 5 years of study participation.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Trastuzumab
Hide Arm/Group Description

trastuzumab: Trastuzumab (Herceptin®) IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.

laboratory biomarker analysis: Blood is collected every 6 weeks during treatment. Samples are assessed for plasma cardiac markers (N-terminal brain natriuretic protein and troponin-I) and pro-inflammatory cytokines (interleukin-6 and tumor necrosis factor-α).

adjuvant therapy: Patients receive trastuzumab (Herceptin®) IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.

quality-of-life assessment: Patients complete Quality of Life and Quality of Health and Comprehensive Geriatric assessments of functional, cognitive, and mental status changes at baseline, weeks 26, and 52.

All-Cause Mortality
Trastuzumab
Affected / at Risk (%)
Total   5/56 (8.93%)    
Hide Serious Adverse Events
Trastuzumab
Affected / at Risk (%) # Events
Total   8/56 (14.29%)    
Blood and lymphatic system disorders   
Platelets * 1  1/56 (1.79%)  1
Cardiac disorders   
Heart failure * 1  1/56 (1.79%)  3
Left ventricular systolic dysfunction * 1  1/56 (1.79%)  1
Gastrointestinal disorders   
Dehydration * 1  1/56 (1.79%)  1
Diarrhea * 1  1/56 (1.79%)  1
Infections and infestations   
Infection with normal ANC or Grade 1 or 2 neutrophils - Bladder (urinary) * 1  1/56 (1.79%)  1
Metabolism and nutrition disorders   
Sodium, serum-low (hyponatremia) * 1  1/56 (1.79%)  2
Musculoskeletal and connective tissue disorders   
Fracture * 1  2/56 (3.57%)  2
Respiratory, thoracic and mediastinal disorders   
Dyspnea (shortness of breath) * 1  1/56 (1.79%)  1
Hypoxia * 1  1/56 (1.79%)  1
Pulmonary/Upper Respiratory - Other (Specify, _Flu_) * 1  1/56 (1.79%)  1
Vascular disorders   
Thrombosis/thrombus/embolism * 1  1/56 (1.79%)  1
1
Term from vocabulary, CTCAE (3.0)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Trastuzumab
Affected / at Risk (%) # Events
Total   17/56 (30.36%)    
Blood and lymphatic system disorders   
Lymphopenia * 1  2/56 (3.57%)  3
Cardiac disorders   
Hypertension * 1  6/56 (10.71%)  7
Left ventricular systolic dysfunction * 1  2/56 (3.57%)  2
Gastrointestinal disorders   
Diarrhea * 1  2/56 (3.57%)  2
General disorders   
Pain-Kidney * 1  1/56 (1.79%)  1
Infections and infestations   
Infection with unknown ANC - Urinary tract NOS * 1  1/56 (1.79%)  1
Metabolism and nutrition disorders   
Glomerular filtration rate * 1  1/56 (1.79%)  2
Glucose, serum-low (hypoglycemia) * 1  1/56 (1.79%)  1
Sodium, serum-low (hyponatremia) * 1  1/56 (1.79%)  2
Musculoskeletal and connective tissue disorders   
Left ankle sprain * 1  1/56 (1.79%)  1
Pain- Buttock * 1  1/56 (1.79%)  1
Nervous system disorders   
CNS cerebrovascular ischemia * 1  1/56 (1.79%)  1
Confusion * 1  1/56 (1.79%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea (shortness of breath) * 1  1/56 (1.79%)  2
Hypoxia * 1  1/56 (1.79%)  1
1
Term from vocabulary, CTCAE (3.0)
*
Indicates events were collected by non-systematic assessment
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: Dr. Cynthia Owusu
Organization: Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Phone: +1 216-844-7670
EMail: cynthia.owusu@uhhospitals.org
Layout table for additonal information
Responsible Party: Cynthia Owusu, MD, Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00796978    
Other Study ID Numbers: CASE10107
P30CA043703 ( U.S. NIH Grant/Contract )
CASE10107 ( Other Identifier: Case Comprehensive Cancer Center )
CASE-10107-CC443 ( Other Identifier: Cancer Center IRB )
First Submitted: November 21, 2008
First Posted: November 24, 2008
Results First Submitted: April 21, 2020
Results First Posted: August 3, 2020
Last Update Posted: August 3, 2020