Breast Cancer
Conditions
Keywords
stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, HER2-positive breast cancer
Brief summary
RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. PURPOSE: This phase II trial is studying the side effects of trastuzumab and to see how well it works in treating older women with early-stage breast cancer.
Detailed description
OBJECTIVES: Primary * To evaluate the 3-year cumulative incidence of cardiac events in women 60 years and older with HER2-positive breast cancer who receive single agent trastuzumab (Herceptin®) in the adjuvant setting. Secondary * To evaluate the 1-year cumulative incidence of asymptomatic cardiac left ventricular dysfunction in women 60 years and older with Her2-positive breast cancer who receive single agent trastuzumab in the adjuvant setting. * To evaluate long-term cardiac toxicity (5-year cumulative incidence of cardiac events) in women 60 years and older with Her2-positive breast cancer who receive single agent trastuzumab in the adjuvant setting. * To assess the relation between physiologic markers of chronic heart failure and trastuzumab-related cardiac dysfunction in women 60 years and older with Her2-positive breast cancer who receive single agent trastuzumab. * To assess the relation between pro-inflammatory cytokines and trastuzumab-related cardiac dysfunction in women 60 years and older with Her2-positive breast cancer. * To determine the effect of this drug on the health-related quality of life and functional, cognitive, and mental status of women 60 years and older with Her2-positive breast cancer. * To determine the 5-year disease-free survival and overall survival of women 60 years and older with Her2-positive breast cancer who receive single agent trastuzumab in the adjuvant setting. OUTLINE: This is a multicenter study. 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. 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). 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. After completion of study therapy, patients are followed periodically for 4 years.
Interventions
BIOLOGICALtrastuzumab
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.
OTHERlaboratory 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).
PROCEDUREadjuvant 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.
PROCEDUREquality-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.
Sponsors
Cynthia Owusu, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed adenocarcinoma of the breast * Immunohistochemical staining for Her2 protein of 3+ intensity or Her2 gene amplification of ≥ 2.0 by FISH testing. * Life expectancy \> 6 months * ECOG performance status ≤ 2 * Node positive disease irrespective of tumor size * Node negative disease: * TNM Stage (AJCC Cancer Staging Manual 6th edition) T1b-T4, N0-3, M0, irrespective of hormonal status * Baseline LVEF ≥ lower limit of normal for a particular institution * Complete surgical removal of invasive cancer by mastectomy or lumpectomy * Complete staging work-up with CT of chest, abdomen, and pelvis plus bone scan or alternatively with PET scan for stage II and higher disease, or as determined by symptoms for all other stages. Additional staging work-up as per symptoms. * Adequate bone marrow function as indicated by the following: * ANC \>1000/µL * Platelets ≥100,000/µL * Hemoglobin \>10 g/dL * Adequate liver function, as indicated by bilirubin ≤1.5 x upper limit of normal (ULN) Adequate renal function, as indicated by creatinine ≤1.5 x ULN * AST or ALT \<2 x ULN unless related to primary disease. * Signed informed consent
Exclusion criteria
* Enrollment after more than 120 days from the last day of mastectomy or lumpectomy * Patients able to tolerate and willing to receive chemotherapy * Prior chemotherapy for current malignancy * Prior herceptin therapy * Active cardiac disease * Myocardial infarction (asymptomatic changes on EKG suggestive of old MI is not an exclusion) * Angina pectoris requiring anti-anginal treatment * Documented congestive heart failure (CHF) * Current use of any therapy specifically for CHF * Cardiac arrhythmia requiring medication * Current uncontrolled hypertension (diastolic \>100 mmHg or systolic \> 200 mmHg) * Clinically significant valvular abnormality (associated with New York Heart Association (NYHA) class II, III, or IV symptoms) * Clinically significant pericardial effusion (associated with New York Heart Association (NYHA) class II, III, or IV symptoms) * Past cardiac disease * Prior myocardial infarction (asymptomatic changes on EKG suggestive of old MI is not an exclusion) * Prior history of CHF * History of cardiomyopathy * Other diseases and conditions * Evidence of metastatic breast cancer (clinical or radiological evidence) * Active infection * Concomitant malignancies or previous malignancies within the last 3 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix. * Hypersensitivity to trastuzumab
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Participants Experiencing Cardiac Events at 1 Year | At 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Participants Experiencing Cardiac Events at 5 Years | At 5 years | 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. |
| Percent of Participants of Asymptomatic Left Ventricular (LV) Cardiac Dysfunction at 1 Year | At 1 year | One-year cumulative incidence of LV cardiac dysfunction as measured by percent of participants that had asymptomatic LV cardiac dysfunction with/without permanent discontinuation |
| Percent of Participants With Asymptomatic LV Cardiac Dysfunction at Three Years | At 3 years | Three-year cumulative incidence of LV cardiac dysfunction as measured by percent of participants that had asymptomatic LV cardiac dysfunction with/without permanent discontinuation |
| Percent of Participants With Asymptomatic LV Cardiac Dysfunction at Five Years | At 5 years | Five-year cumulative incidence as measured by percent of participants that had asymptomatic LV cardiac dysfunction with/without permanent discontinuation |
| Percent of Participants With Disease-free Survival (DFS) | At 1 year | 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. |
| Percent of Participants With DFS | At 2 years | 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. |
| Overall Survival (OS) as Measured by Percent of Participants Alive at 1 Year | Up to 1 years | 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. |
| Overall Survival (OS) as Measured by Percent of Participants Alive at 2 Years | Up to 2 years | 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. |
| Overall Survival (OS) as Measured by Percent of Participants Alive at 3 Years | Up to 3 years | 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. |
| Percent of Participants Experiencing Cardiac Events at 3 Years | At 3 years | 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. |
| Mean Change in Quality of Life From Baseline to Mid-treatment | From Baseline to mid-treatment (week 26) | Quality of life was assessed by using the mean change in Functional Assessment of Cancer Therapy-Breast (FACTB) scoring instrument. The Functional Assessment of Cancer Therapy-Breast (FACT-B) is a 37-item instrument designed to measure five domains of HRQOL in breast cancer patients: Physical, social, emotional, and functional well-being, as well as a breast-cancer subscale (BCS). Each question response is based on a 5-point Likert-type scale. Scores range from 0-148. High scores indicate better QOL. |
| Mean Change in Quality of Life From Baseline to End of Treatment | From baseline to end-of-treatment (52 weeks) | Quality of life was assessed by using the mean change in Functional Assessment of Cancer Therapy-Breast (FACTB) scoring instrument. The Functional Assessment of Cancer Therapy-Breast (FACT-B) is a 37-item instrument designed to measure five domains of HRQOL in breast cancer patients: Physical, social, emotional, and functional well-being, as well as a breast-cancer subscale (BCS). Each question response is based on a 5-point Likert-type scale. Scores range from 0-148. High scores indicate better QOL. |
| Mean Change in Functional Status | From Baseline to mid-treatment (week 26) | Mean Change in ADL/IADL scores From Baseline to Mid-treatment. The functional status will be measured by a Comprehensive Geriatric Assessment comprised of two validated instruments: Katz's Activity of Daily Living (ADL) instrument and Lawton's Instrumental of Activities of Daily Living (IADL). The IADL scale contains eight items with a summary score from 0 (low function) to 8 (high function), with higher scores indicating higher function. The ADL scale contains six items with a summary score of 0 to 6, with higher scores indicating higher independence. A score of 6 indicates complete independence; a score of 4 indicates moderate impairment; 2 or less indicates severe functional impairment. The scores of both scales will be added together for a comprehensive geriatric assessment score. |
| Mean Change in Cognitive Status | From Baseline to mid-treatment (week 26) | Mean Change in Mini Mental Status Exam (MMSE scores) From Baseline to Mid-treatment. The Mini-Mental Status Exam contains 11 items to gauge cognitive function. The minimum score is 0. The maximum score is 30. A score of 23 or lower is indicative of cognitive impairment. The higher the score, the better the participant's function (Scores 30-24 indicate uncertain cognitive impairment; scores 23-18 indicate mild to moderate cognitive impairment; scores 17-0 indicate severe cognitive impairment). |
| Mean Change in Psychosocial Status (Depression) | From Baseline to mid-treatment (week 26) | Mean Change in Geriatric Depression Scores From Baseline to Mid-treatment. The Geriatric Depression Scale (GDS) is a validated tool with 15 items. The minimum score is 0, and the maximum is 15. Scores of 0-4 are considered normal, depending on age, education, and complaints; 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression. |
| Mean Change in Psychosocial Status (Social Support) | From Baseline to mid-treatment (week 26) | Mean Change in MOS social support scores From Baseline to Mid-treatment. The Medical Outcomes Study (MOS) Social Support survey tool measures multiple domains. It is a 19-item tool comprised of four subscales in one overall summary index. The subscales are Emotional/Informational Support, Tangible Support, Affectionate support, and Positive Social Interaction. The overall index score is determined by calculating the mean of all 19 items. Scores range from 19 to 95, with higher scores indicating high support availability to participants. |
| Mean Change in Nutritional Status | From Baseline to mid-treatment (week 26) | Mean Change in Mini Nutrition Assessment scores From Baseline to Mid-treatment. The Mini Nutritional Screening is a scale comprised of six questions. The sum of the six questions is totaled to determine a score which is designed to assess if there is a risk of malnutrition. The highest score possible, 14, indicated no risk, and the minimum score of 0 indicates the highest risk possible. 12 points or greater is considered no risk or normal. Meanwhile, a score below 11 indicates possible malnutrition. |
| Mean Change in Pro-inflammatory Cytokines | From Baseline to mid-treatment (week 26) | Mean change in pro-inflammatory cytokines from baseline to mid-treatment |
| Mean Change in Plasma Cardiac Markers | From Baseline to mid-treatment (week 26) | Mean change in plasma cardiac markers from baseline to mid-treatment |
| Overall Survival (OS) as Measured by Percent of Participants Alive at 5 Years | Up to 5 years | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Trastuzumab 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. | 56 |
| Total | 56 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 4 |
| Overall Study | Cardiac adverse event | 5 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Trastuzumab |
|---|---|
| Age, Customized years 60-69 | 19 Participants |
| Age, Customized years 70-79 | 23 Participants |
| Age, Customized years 80-89 | 13 Participants |
| Age, Customized years 90-99 | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 55 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 49 Participants |
| Region of Enrollment United States | 56 participants |
| Sex: Female, Male Female | 56 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 5 / 56 |
| other Total, other adverse events | 17 / 56 |
| serious Total, serious adverse events | 8 / 56 |
Outcome results
Primary
Percent of Participants Experiencing Cardiac Events at 1 Year
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Trastuzumab | Percent of Participants Experiencing Cardiac Events at 1 Year | 3.6 percentage of participants |
Secondary
Mean Change in Cognitive Status
Mean Change in Mini Mental Status Exam (MMSE scores) From Baseline to Mid-treatment. The Mini-Mental Status Exam contains 11 items to gauge cognitive function. The minimum score is 0. The maximum score is 30. A score of 23 or lower is indicative of cognitive impairment. The higher the score, the better the participant's function (Scores 30-24 indicate uncertain cognitive impairment; scores 23-18 indicate mild to moderate cognitive impairment; scores 17-0 indicate severe cognitive impairment).
Time frame: From Baseline to mid-treatment (week 26)
Population: Only participants with no missing values at baseline and mid treatment and at baseine and end of treatment were included
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Trastuzumab | Mean Change in Cognitive Status | 0 score on a scale | Standard Deviation 1.94 |
Secondary
Mean Change in Cognitive Status
Mean Change in Mini Mental Status Exam (MMSE scores) From Baseline to End of Treatment. The Mini-Mental Status Exam contains 11 items to gauge cognitive function. The minimum score is 0. The maximum score is 30. A score of 23 or lower is indicative of cognitive impairment. The higher the score, the better the participant's function (Scores 30-24 indicate uncertain cognitive impairment; scores 23-18 indicate mild to moderate cognitive impairment; scores 17-0 indicate severe cognitive impairment).
Time frame: From baseline to end-of-treatment (52 weeks)
Population: Only participants with no missing values at baseline and mid-treatment and at baseline and end of treatment were included
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Trastuzumab | Mean Change in Cognitive Status | -0.59 score on a scale | Standard Deviation 1.15 |
Secondary
Mean Change in Functional Status
Mean Change in ADL/IADL scores From Baseline to End of Treatment. The functional status will be measured by a Comprehensive Geriatric Assessment comprised of two validated instruments: Katz's Activity of Daily Living (ADL) instrument and Lawton's Instrumental of Activities of Daily Living (IADL). The IADL scale contains eight items with a summary score from 0 (low function) to 8 (high function), with higher scores indicating higher function. The ADL scale contains six items with a summary score of 0 to 6, with higher scores indicating higher independence. A score of 6 indicates complete independence; a score of 4 indicates moderate impairment; 2 or less indicates severe functional impairment. The scores of both scales will be added together for a comprehensive geriatric assessment score.
Time frame: baseline to end-of-treatment (52 weeks)
Population: Only participants with no missing values at baseline and mid-treatment and at baseline and end of treatment were included
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Trastuzumab | Mean Change in Functional Status | -0.26 score on a scale | Standard Deviation 1.15 |
Secondary
Mean Change in Functional Status
Mean Change in ADL/IADL scores From Baseline to Mid-treatment. The functional status will be measured by a Comprehensive Geriatric Assessment comprised of two validated instruments: Katz's Activity of Daily Living (ADL) instrument and Lawton's Instrumental of Activities of Daily Living (IADL). The IADL scale contains eight items with a summary score from 0 (low function) to 8 (high function), with higher scores indicating higher function. The ADL scale contains six items with a summary score of 0 to 6, with higher scores indicating higher independence. A score of 6 indicates complete independence; a score of 4 indicates moderate impairment; 2 or less indicates severe functional impairment. The scores of both scales will be added together for a comprehensive geriatric assessment score.
Time frame: From Baseline to mid-treatment (week 26)
Population: Only participants with no missing values at baseline and mid-treatment and at baseline and end of treatment were included
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Trastuzumab | Mean Change in Functional Status | -0.05 score on a scale | Standard Deviation 0.74 |
Secondary
Mean Change in Nutritional Status
Mean Change in Mini Nutrition Assessment scores From Baseline to Mid-treatment. The Mini Nutritional Screening is a scale comprised of six questions. The sum of the six questions is totaled to determine a score which is designed to assess if there is a risk of malnutrition. The highest score possible, 14, indicated no risk, and the minimum score of 0 indicates the highest risk possible. 12 points or greater is considered no risk or normal. Meanwhile, a score below 11 indicates possible malnutrition.
Time frame: From Baseline to mid-treatment (week 26)
Population: Only participants with no missing values at baseline and mid-treatment and at baseline and end of treatment were included
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Trastuzumab | Mean Change in Nutritional Status | 0.14 score on a scale | Standard Deviation 2.11 |
Secondary
Mean Change in Nutritional Status
Mean Change in Mini Nutrition Assessment scores From Baseline to End of Treatment. The Mini Nutritional Screening is a scale comprised of six questions. The sum of the six questions is totaled to determine a score which is designed to assess if there is a risk of malnutrition. The highest score possible, 14, indicated no risk, and the minimum score of 0 indicates the highest risk possible. 12 points or greater is considered no risk or normal. Meanwhile, a score below 11 indicates possible malnutrition.
Time frame: From baseline to end-of-treatment (52 weeks)
Population: Only participants with no missing values at baseline and mid-treatment and at baseline and end of treatment were included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Trastuzumab | Mean Change in Nutritional Status | -0.39 score on a scale | Standard Deviation 2.47 |
Secondary
Mean Change in Plasma Cardiac Markers
Mean change in plasma cardiac markers from baseline end of treatment
Time frame: From baseline to end-of-treatment (52 weeks)
Population: Unable to complete analysis due to too many missing values that affected the validity of results and interpretation of data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Trastuzumab | Mean Change in Plasma Cardiac Markers | NA pg/ml |
Secondary
Mean Change in Plasma Cardiac Markers
Mean change in plasma cardiac markers from baseline to mid-treatment
Time frame: From Baseline to mid-treatment (week 26)
Population: Unable to complete analysis due to too many missing values that affected the validity of results and interpretation of data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Trastuzumab | Mean Change in Plasma Cardiac Markers | NA pg/ml |
Secondary
Mean Change in Pro-inflammatory Cytokines
Mean change in pro-inflammatory cytokines from baseline to mid-treatment
Time frame: From Baseline to mid-treatment (week 26)
Population: Analysis was not completed due to too many missing values that affected the validity of results and interpretation of data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Trastuzumab | Mean Change in Pro-inflammatory Cytokines | NA pg/ml |
Secondary
Mean Change in Pro-inflammatory Cytokines
Mean change in pro-inflammatory cytokines from baseline to end of treatment
Time frame: From baseline to end-of-treatment (52 weeks)
Population: Unable to complete analysis due to too many missing values that affected the validity of results and interpretation of data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Trastuzumab | Mean Change in Pro-inflammatory Cytokines | NA pg/ml |
Secondary
Mean Change in Psychosocial Status (Depression)
Mean Change in Geriatric Depression Scores From Baseline to Mid-treatment. The Geriatric Depression Scale (GDS) is a validated tool with 15 items. The minimum score is 0, and the maximum is 15. Scores of 0-4 are considered normal, depending on age, education, and complaints; 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression.
Time frame: From Baseline to mid-treatment (week 26)
Population: Only participants with no missing values at baseline and mid-treatment and at baseline and end of treatment were included
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Trastuzumab | Mean Change in Psychosocial Status (Depression) | 0.15 score on a scale | Standard Deviation 1.6 |
Secondary
Mean Change in Psychosocial Status (Depression)
Mean Change in Geriatric Depression Scores from Baseline to End of Treatment. The Geriatric Depression Scale (GDS) is a validated tool with 15 items. The minimum score is 0, and the maximum is 15. Scores of 0-4 are considered normal, depending on age, education, and complaints; 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression.
Time frame: From baseline to end-of-treatment (52 weeks)
Population: Only participants with no missing values at baseline and mid-treatment and at baseline and end of treatment were included
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Trastuzumab | Mean Change in Psychosocial Status (Depression) | -0.39 score on a scale | Standard Deviation 1.83 |
Secondary
Mean Change in Psychosocial Status (Social Support)
Mean Change in MOS social support scores From Baseline to Mid-treatment. The Medical Outcomes Study (MOS) Social Support survey tool measures multiple domains. It is a 19-item tool comprised of four subscales in one overall summary index. The subscales are Emotional/Informational Support, Tangible Support, Affectionate support, and Positive Social Interaction. The overall index score is determined by calculating the mean of all 19 items. Scores range from 19 to 95, with higher scores indicating high support availability to participants.
Time frame: From Baseline to mid-treatment (week 26)
Population: Only participants with no missing values at baseline and mid-treatment and at baseline and end of treatment were included
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Trastuzumab | Mean Change in Psychosocial Status (Social Support) | -1.03 score on a scale | Standard Deviation 22.4 |
Secondary
Mean Change in Psychosocial Status (Social Support)
Mean Change in MOS social support scores From Baseline to End of Treatment. The Medical Outcomes Study (MOS) Social Support survey tool measures multiple domains. It is a 19-item tool comprised of four subscales in one overall summary index. The subscales are Emotional/Informational Support, Tangible Support, Affectionate support, and Positive Social Interaction. The overall index score is determined by calculating the mean of all 19 items. Scores range from 19 to 95, with higher scores indicating high support availability to participants.
Time frame: From baseline to end-of-treatment (52 weeks)
Population: Only participants with no missing values at baseline and mid treatment and at baseine and end of treatment were included
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Trastuzumab | Mean Change in Psychosocial Status (Social Support) | -7.53 score on a scale | Standard Deviation 22.12 |
Secondary
Mean Change in Quality of Life From Baseline to End of Treatment
Quality of life was assessed by using the mean change in Functional Assessment of Cancer Therapy-Breast (FACTB) scoring instrument. The Functional Assessment of Cancer Therapy-Breast (FACT-B) is a 37-item instrument designed to measure five domains of HRQOL in breast cancer patients: Physical, social, emotional, and functional well-being, as well as a breast-cancer subscale (BCS). Each question response is based on a 5-point Likert-type scale. Scores range from 0-148. High scores indicate better QOL.
Time frame: From baseline to end-of-treatment (52 weeks)
Population: Only participants with no missing values at baseline and mid-treatment and at baseline and end of treatment were included
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Trastuzumab | Mean Change in Quality of Life From Baseline to End of Treatment | -9.2 score on a scale | Standard Deviation 24.3 |
Secondary
Mean Change in Quality of Life From Baseline to Mid-treatment
Quality of life was assessed by using the mean change in Functional Assessment of Cancer Therapy-Breast (FACTB) scoring instrument. The Functional Assessment of Cancer Therapy-Breast (FACT-B) is a 37-item instrument designed to measure five domains of HRQOL in breast cancer patients: Physical, social, emotional, and functional well-being, as well as a breast-cancer subscale (BCS). Each question response is based on a 5-point Likert-type scale. Scores range from 0-148. High scores indicate better QOL.
Time frame: From Baseline to mid-treatment (week 26)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Trastuzumab | Mean Change in Quality of Life From Baseline to Mid-treatment | -2.8 score on a scale | Standard Deviation 17.9 |
Secondary
Overall Survival (OS) as Measured by Percent of Participants Alive at 1 Year
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
Population: All participants that received treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Trastuzumab | Overall Survival (OS) as Measured by Percent of Participants Alive at 1 Year | 100.0 percent of participants |
Secondary
Overall Survival (OS) as Measured by Percent of Participants Alive at 2 Years
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
Population: All participants that received treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Trastuzumab | Overall Survival (OS) as Measured by Percent of Participants Alive at 2 Years | 100.0 percent of participants |
Secondary
Overall Survival (OS) as Measured by Percent of Participants Alive at 3 Years
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
Population: All participants that received treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Trastuzumab | Overall Survival (OS) as Measured by Percent of Participants Alive at 3 Years | 94.23 percent of participants |
Secondary
Overall Survival (OS) as Measured by Percent of Participants Alive at 5 Years
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
Population: All participants that received treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Trastuzumab | Overall Survival (OS) as Measured by Percent of Participants Alive at 5 Years | 90.2 percent of participants |
Secondary
Percent of Participants Experiencing Cardiac Events at 3 Years
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
Population: Data from 3-year and 5-year echocardiograms not collected, CI of cardiac events and asymptomatic LV cardiac dysfunction were not available
Secondary
Percent of Participants Experiencing Cardiac Events at 5 Years
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
Population: Data from 3-year and 5-year echocardiograms not collected, CI of cardiac events and asymptomatic LV cardiac dysfunction were not available
Secondary
Percent of Participants of Asymptomatic Left Ventricular (LV) Cardiac Dysfunction at 1 Year
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Trastuzumab | Percent of Participants of Asymptomatic Left Ventricular (LV) Cardiac Dysfunction at 1 Year | 9.1 percent of participants |
Secondary
Percent of Participants With Asymptomatic LV Cardiac Dysfunction at Five Years
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
Population: Data from 3-year and 5-year echocardiograms not collected, CI of cardiac events and asymptomatic LV cardiac dysfunction were not available
Secondary
Percent of Participants With Asymptomatic LV Cardiac Dysfunction at Three Years
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
Population: Data from 3-year and 5-year echocardiograms not collected, CI of cardiac events and asymptomatic LV cardiac dysfunction were not available
Secondary
Percent of Participants With DFS
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
Population: All participants that received treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Trastuzumab | Percent of Participants With DFS | 94.47 percentage of participants |
Secondary
Percent of Participants With Disease-free Survival (DFS)
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
Population: All participants that received treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Trastuzumab | Percent of Participants With Disease-free Survival (DFS) | 96.36 Percent of participants |
Secondary
Percent of Participants With Disease-free Survival (DFS)
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
Population: All participants that received treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Trastuzumab | Percent of Participants With Disease-free Survival (DFS) | 86.4 percentage of participants |
Secondary
Percent of Participants With Disease-free Survival (DFS)
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
Population: All participants that received treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Trastuzumab | Percent of Participants With Disease-free Survival (DFS) | 92.46 percentage of participants |