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
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Study Type | Interventional |
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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 |
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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 | |
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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. |
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Overall Number of Baseline Participants | 56 | |
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All participants who went on study
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Age, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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years | Number Analyzed | 56 participants |
60-69 |
19 33.9%
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70-79 |
23 41.1%
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80-89 |
13 23.2%
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90-99 |
1 1.8%
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 56 participants | |
Female |
56 100.0%
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Male |
0 0.0%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 56 participants | |
Hispanic or Latino |
1 1.8%
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Not Hispanic or Latino |
55 98.2%
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Unknown or Not Reported |
0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 56 participants | |
American Indian or Alaska Native |
0 0.0%
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Asian |
0 0.0%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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Black or African American |
7 12.5%
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White |
49 87.5%
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More than one race |
0 0.0%
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Unknown or Not Reported |
0 0.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 56 participants |
56 |
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 |