Trastuzumab in Treating Older Women With Early-Stage Breast Cancer

• 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: Cynthia Owusu, MD
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Trastuzumab
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

Baseline Characteristics

Arm/Group Title		Trastuzumab
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
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

Outcome Measures

1. Primary Outcome

Title	Percent of Participants Experiencing Cardiac Events at 1 Year
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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)
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

Outcome Measure Data

Analysis Population Description

All participants that received treatment.

Arm/Group Title	Trastuzumab
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
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

Outcome Measure Data

Analysis Population Description

All participants that received treatment.

Arm/Group Title	Trastuzumab
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)
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

Outcome Measure Data

Analysis Population Description

All participants that received treatment.

Arm/Group Title	Trastuzumab
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)
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

Outcome Measure Data

Analysis Population Description

All participants that received treatment.

Arm/Group Title	Trastuzumab
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
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

Outcome Measure Data

Analysis Population Description

All participants that received treatment.

Arm/Group Title	Trastuzumab
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
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

Outcome Measure Data

Analysis Population Description

All participants that received treatment.

Arm/Group Title	Trastuzumab
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
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

Outcome Measure Data

Analysis Population Description

All participants that received treatment.

Arm/Group Title	Trastuzumab
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
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

Outcome Measure Data

Analysis Population Description

All participants that received treatment.

Arm/Group Title	Trastuzumab
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
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
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
Description	[Not Specified]
Time Frame	Every 6 weeks during treatment up to three years

Outcome Measure Data Not Reported

Adverse Events

Time Frame	Adverse Event Data was collected up to 5 years of study participation.
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Trastuzumab
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%)
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
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

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• 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

• 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