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Trastuzumab in Treating Older Women With Early-Stage Breast Cancer

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ClinicalTrials.gov Identifier: NCT00796978
Recruitment Status : Active, not recruiting
First Posted : November 24, 2008
Last Update Posted : January 10, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Cynthia Owusu, MD, Case Comprehensive Cancer Center

Tracking Information
First Submitted Date  ICMJE November 21, 2008
First Posted Date  ICMJE November 24, 2008
Last Update Posted Date January 10, 2019
Actual Study Start Date  ICMJE November 11, 2008
Actual Primary Completion Date January 12, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 8, 2019)
Three-year cumulative incidence of cardiac events [ Time Frame: every 6 weeks during treatment up to three years ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 21, 2008)
Three-year cumulative incidence of cardiac events
Change History Complete list of historical versions of study NCT00796978 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 8, 2019)
  • One-year cumulative incidence of asymptomatic left ventricular cardiac dysfunction [ Time Frame: every 6 weeks during treatment up to one year ]
  • Five-year cumulative incidence of asymptomatic left ventricular cardiac dysfunction [ Time Frame: every 6 weeks during treatment up to five years ]
  • Five-year cumulative incidence of all cardiac events [ Time Frame: every 6 weeks during treatment up to five years ]
  • Mean change in plasma cardiac markers from baseline to mid-treatment and baseline to end of treatment [ Time Frame: every 6 weeks during treatment up to three years ]
  • Mean change in pro-inflammatory cytokines from baseline to mid-treatment and baseline to end of treatment [ Time Frame: every 6 weeks during treatment up to three years ]
  • Mean change in quality of life and comprehensive geriatric assessment scores from baseline to mid-treatment and baseline to end of treatment [ Time Frame: baseline to week 26 and baseline to 52 weeks after being on study ]
  • Disease-free survival [ Time Frame: Up to 4 years ]
  • Overall survival [ Time Frame: Up to 4 years. ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2008)
  • Three-year cumulative incidence of asymptomatic left ventricular cardiac dysfunction
  • Mean change in plasma cardiac markers from baseline to mid-treatment and baseline to end of treatment
  • Mean change in pro-inflammatory cytokines from baseline to mid-treatment and baseline to end of treatment
  • Mean change in quality of life and comprehensive geriatric assessment scores from baseline to mid-treatment and baseline to end of treatment
  • Disease-free survival
  • Overall survival
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trastuzumab in Treating Older Women With Early-Stage Breast Cancer
Official Title  ICMJE Safety and Efficacy of Single Agent Adjuvant Trastuzumab (Herceptin®) in Older Women With Early-Stage and Locally Advanced Breast Cancer: A Phase II Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Biological: 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.
    Other Name: Herceptin
  • Other: 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).
  • Procedure: 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.
  • Procedure: 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.
Study Arms  ICMJE Experimental: trastuzumab
Interventions:
  • Biological: trastuzumab
  • Other: laboratory biomarker analysis
  • Procedure: adjuvant therapy
  • Procedure: quality-of-life assessment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 13, 2015)
56
Original Estimated Enrollment  ICMJE
 (submitted: November 21, 2008)
124
Estimated Study Completion Date  ICMJE January 12, 2020
Actual Primary Completion Date January 12, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00796978
Other Study ID Numbers  ICMJE CASE10107
P30CA043703 ( U.S. NIH Grant/Contract )
CASE10107 ( Other Identifier: Case Comprehensive Cancer Center )
CASE-10107-CC443 ( Other Identifier: Cancer Center IRB )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cynthia Owusu, MD, Case Comprehensive Cancer Center
Study Sponsor  ICMJE Cynthia Owusu, MD
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Cynthia Owusu, MD, MSc University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
PRS Account Case Comprehensive Cancer Center
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP