Breast CancerPhase 2NCT00796978
Trastuzumab in Treating Older Women With Early-Stage Breast Cancer
A Phase 2 study testing trastuzumab, laboratory biomarker analysis and adjuvant therapy in people with Breast Cancer, run by Cynthia Owusu, MD at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- trastuzumab, laboratory biomarker analysis and adjuvant therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 11 sitesUnited States
- Study dates
- 5 Feb 2009to 26 Feb 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 17Show fewer
- 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
Who cannot join
- 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)
Show all 22Show fewer
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Lake/University Seidman Cancer Center
Cleveland, Ohio, 44060
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
University Suburban Health Center
Cleveland, Ohio, 44121
UHHS Chagrin Highlands Medical Center
Cleveland, Ohio, 44122
Southwest General Health Center
Cleveland, Ohio, 44130
UHHS Westlake Medical Center
Cleveland, Ohio, 44145
UH-Monarch
Mayfield Heights, Ohio, 44124
University of Miami, Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
University of Pittsburgh
Pittsburgh, Pennsylvania, 15232
Sharon Health Center
Wadsworth, Ohio, 44281
Wake Forrest
Winston-Salem, North Carolina, 27157
About this study
Official title: Safety and Efficacy of Single Agent Adjuvant Trastuzumab (Herceptin®) in Older Women With Early-Stage and Locally Advanced Breast Cancer: A Phase II Trial
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- trastuzumab, laboratory biomarker analysis, adjuvant therapy, quality-of-life assessment
- 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
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trastuzumabBiological
Also called Herceptin
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 analysisOther
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 therapyProcedure or surgery
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 assessmentProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| trastuzumab | Experimental | Not described Receives: Biological: trastuzumab; Other: laboratory biomarker analysis; Procedure: adjuvant therapy; Procedure: quality-of-life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 1 year
Secondary outcomes (29)
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.
Measured: At 3 years
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.
Measured: At 5 years
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
Measured: At 1 year
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
Measured: At 3 years
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
Measured: At 5 years
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.
Measured: At 1 year
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.
Measured: At 2 years
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.
Measured: At 3 years
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.
Measured: At 5 years
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.
Measured: Up to 1 years
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.
Measured: Up to 2 years
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.
Measured: Up to 3 years
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.
Measured: Up to 5 years
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.
Measured: From Baseline to mid-treatment (week 26)
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.
Measured: From baseline to end-of-treatment (52 weeks)
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.
Measured: From Baseline to mid-treatment (week 26)
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.
Measured: baseline to end-of-treatment (52 weeks)
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).
Measured: From Baseline to mid-treatment (week 26)
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).
Measured: From baseline to end-of-treatment (52 weeks)
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.
Measured: From Baseline to mid-treatment (week 26)
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.
Measured: From baseline to end-of-treatment (52 weeks)
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.
Measured: From Baseline to mid-treatment (week 26)
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.
Measured: From baseline to end-of-treatment (52 weeks)
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.
Measured: From Baseline to mid-treatment (week 26)
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.
Measured: From baseline to end-of-treatment (52 weeks)
Mean Change in Pro-inflammatory Cytokines
Mean change in pro-inflammatory cytokines from baseline to mid-treatment
Measured: From Baseline to mid-treatment (week 26)
Mean Change in Pro-inflammatory Cytokines
Mean change in pro-inflammatory cytokines from baseline to end of treatment
Measured: From baseline to end-of-treatment (52 weeks)
Mean Change in Plasma Cardiac Markers
Mean change in plasma cardiac markers from baseline to mid-treatment
Measured: From Baseline to mid-treatment (week 26)
Mean Change in Plasma Cardiac Markers
Mean change in plasma cardiac markers from baseline end of treatment
Measured: From baseline to end-of-treatment (52 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2008 (estimated)
- Study start5 Feb 2009
- Primary completion6 Jan 2016
- Study completion26 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cynthia Owusu, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cynthia Owusu, MD, Case Comprehensive Cancer Center
- Investigators
- Cynthia Owusu, MD, MSc, Principal investigator, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00796978
- Sponsor's protocol ID
- CASE10107
- Status last verified
- Apr 2024
- First submitted
- 21 Nov 2008
- Last updated
- 1 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Single Agent Adjuvant Trastuzumab (Herceptin®) in Older Women With Early-Stage and Locally Advanced Breast Cancer: A Phase II Trial
- ClinicalTrials.gov ID
- NCT00796978
- Acronym / sponsor ID
- CASE10107
- Conditions
- Breast Cancer
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Cynthia Owusu, MDUniversity, hospital or other
- Study start
- 5 Feb 2009 (actual)
- Primary completion
- 6 Jan 2016 (actual)
- Study completion
- 26 Feb 2020 (actual)
- First posted
- 24 Nov 2008 (estimated)
- Results
- Posted 3 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| trastuzumab | Experimental | Biological: trastuzumab, Other: laboratory biomarker analysis, Procedure: adjuvant therapy, Procedure: quality-of-life assessment |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| trastuzumabAlso: HerceptinTrastuzumab (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. | Biological | trastuzumab |
| laboratory biomarker analysisBlood 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). | Other | trastuzumab |
| adjuvant therapyPatients 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. | Procedure or surgery | trastuzumab |
| quality-of-life assessmentPatients 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. | Procedure or surgery | trastuzumab |
Primary outcome
Percent of Participants Experiencing Cardiac Events at 1 Year
Time frame: 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.
29 secondary outcomes
Percent of Participants Experiencing Cardiac Events at 3 Years
Time frame: At 3 years
Percent of Participants Experiencing Cardiac Events at 5 Years
Time frame: At 5 years
Percent of Participants of Asymptomatic Left Ventricular (LV) Cardiac Dysfunction at 1 Year
Time frame: At 1 year
Percent of Participants With Asymptomatic LV Cardiac Dysfunction at Three Years
Time frame: At 3 years
Percent of Participants With Asymptomatic LV Cardiac Dysfunction at Five Years
Time frame: At 5 years
Percent of Participants With Disease-free Survival (DFS)
Time frame: At 1 year
Percent of Participants With DFS
Time frame: At 2 years
Percent of Participants With Disease-free Survival (DFS)
Time frame: At 3 years
Percent of Participants With Disease-free Survival (DFS)
Time frame: At 5 years
Overall Survival (OS) as Measured by Percent of Participants Alive at 1 Year
Time frame: Up to 1 years
Overall Survival (OS) as Measured by Percent of Participants Alive at 2 Years
Time frame: Up to 2 years
Overall Survival (OS) as Measured by Percent of Participants Alive at 3 Years
Time frame: Up to 3 years
Overall Survival (OS) as Measured by Percent of Participants Alive at 5 Years
Time frame: Up to 5 years
Mean Change in Quality of Life From Baseline to Mid-treatment
Time frame: From Baseline to mid-treatment (week 26)
Mean Change in Quality of Life From Baseline to End of Treatment
Time frame: From baseline to end-of-treatment (52 weeks)
Mean Change in Functional Status
Time frame: From Baseline to mid-treatment (week 26)
Mean Change in Functional Status
Time frame: baseline to end-of-treatment (52 weeks)
Mean Change in Cognitive Status
Time frame: From Baseline to mid-treatment (week 26)
Mean Change in Cognitive Status
Time frame: From baseline to end-of-treatment (52 weeks)
Mean Change in Psychosocial Status (Depression)
Time frame: From Baseline to mid-treatment (week 26)
Mean Change in Psychosocial Status (Depression)
Time frame: From baseline to end-of-treatment (52 weeks)
Mean Change in Psychosocial Status (Social Support)
Time frame: From Baseline to mid-treatment (week 26)
Mean Change in Psychosocial Status (Social Support)
Time frame: From baseline to end-of-treatment (52 weeks)
Mean Change in Nutritional Status
Time frame: From Baseline to mid-treatment (week 26)
Mean Change in Nutritional Status
Time frame: From baseline to end-of-treatment (52 weeks)
Mean Change in Pro-inflammatory Cytokines
Time frame: From Baseline to mid-treatment (week 26)
Mean Change in Pro-inflammatory Cytokines
Time frame: From baseline to end-of-treatment (52 weeks)
Mean Change in Plasma Cardiac Markers
Time frame: From Baseline to mid-treatment (week 26)
Mean Change in Plasma Cardiac Markers
Time frame: From baseline to end-of-treatment (52 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia Owusu, MD, MSc principal investigator
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing trastuzumab, laboratory biomarker analysis and adjuvant therapy in people with Breast Cancer, run by Cynthia Owusu, MD at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Participants Experiencing Cardiac Events at 1 Year (time frame: At 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2024.