Trial record 12 of 90 for:    heart block | Open Studies | NIH, U.S. Fed

Trastuzumab in Treating Older Women With Early-Stage Breast Cancer

This study is currently recruiting participants.
Verified September 2012 by Case Comprehensive Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00796978
First received: November 21, 2008
Last updated: September 10, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Biological: trastuzumab
Other: laboratory biomarker analysis
Procedure: adjuvant therapy
Procedure: quality-of-life assessment
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Single Agent Adjuvant Trastuzumab in Older Women With Early Stage Breast Cancer: A Phase II Trial

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • Three-year cumulative incidence of cardiac events [ Time Frame: every 6 weeks during treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Three-year cumulative incidence of asymptomatic left ventricular cardiac dysfunction [ Time Frame: every 6 weeks during treatment ] [ Designated as safety issue: Yes ]
  • Mean change in plasma cardiac markers from baseline to mid-treatment and baseline to end of treatment [ Time Frame: every 6 weeks during treatment ] [ Designated as safety issue: No ]
  • Mean change in pro-inflammatory cytokines from baseline to mid-treatment and baseline to end of treatment [ Time Frame: every 6 weeks during treatment ] [ Designated as safety issue: No ]
  • 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 mid-treatment and baseline to end of treatment ] [ Designated as safety issue: No ]
  • Disease-free survival [ Time Frame: followed periodically for 4 years. ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: followed periodically for 4 years. ] [ Designated as safety issue: No ]

Estimated Enrollment: 124
Study Start Date: November 2008
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: trastuzumab 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.

Detailed Description:

OBJECTIVES:

Primary

  • To evaluate the 3-year cumulative incidence of cardiac events in older women with HER2-positive early stage breast cancer treated with adjuvant trastuzumab (Herceptin®).

Secondary

  • To evaluate the 3-year cumulative incidence of asymptomatic cardiac left ventricular dysfunction in these patients.
  • To assess the relation between physiologic markers of chronic heart failure and trastuzumab-related cardiac dysfunction in these patients.
  • To assess the relation between pro-inflammatory cytokines and trastuzumab-related cardiac dysfunction in these patients.
  • To determine the effect of this drug on the health-related quality of life and functional, cognitive, and mental status of these patients.
  • To determine the 3-year disease-free survival and overall survival of these patients.

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the breast

    • Early stage disease (any T, any N, M0)
    • No metastatic disease
  • Must have undergone complete surgical removal of invasive cancer by mastectomy or lumpectomy with either sentinel or axillary lymph node dissection within the past 84 days

    • Must have received either whole or partial breast radiotherapy by external beam or brachytherapy after completion of primary surgery
  • Unable or unwilling to receive chemotherapy
  • HER2-positive, defined 3+ by IHC or HER2 gene amplification by FISH
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Menopausal status not specified
  • ECOG performance status 0-2
  • Life expectancy > 6 months
  • ANC > 1,500/μL
  • Platelet count ≥ 100,000/μL
  • Hemoglobin > 10 g/dL
  • Bilirubin ≤ 1.5 times the upper limit of normal (ULN)
  • Creatinine ≤ 1.5 times ULN
  • AST or ALT < 2 times ULN (unless related to primary disease)
  • LVEF normal
  • Ejection fraction ≥ 50%
  • No active cardiac disease, including any of the following:

    • Prior myocardial infarction (MI) (asymptomatic changes suggestive of old MI on EKG allowed)
    • Angina pectoris requiring anti-anginal treatment
    • Documented CHF
    • Cardiac arrhythmia requiring medication
    • Uncontrolled hypertension (diastolic BP > 100 mm Hg or systolic BP > 200 mm Hg)
    • Clinically significant valvular abnormality or pericardial effusion (associated with NYHA class II-IV symptoms)
  • No history of CHF or cardiomyopathy
  • No concurrent or prior malignancies within the past 5 years, except adequately treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
  • No symptomatic intrinsic lung disease or extensive tumor involvement of the lungs resulting in dyspnea at rest
  • No active infection
  • No emotional limitations
  • No hypersensitivity to trastuzumab (Herceptin®)

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior chemotherapy for this disease
  • No prior trastuzumab (Herceptin®)

    • Adjuvant trastuzumab during radiotherapy allowed
  • No concurrent therapy specifically for congestive heart failure (CHF)
  • No other concurrent chemotherapy or biologic agents

    • Hormonal therapy for patients with hormone receptor-positive disease allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00796978

Contacts
Contact: Cynthia Owusu, MD 216-983-3288 cynthia.owusu@uhhospitals.org

Locations
United States, Florida
University of Miami, Sylvester Comprehensive Cancer Center Not yet recruiting
Miami, Florida, United States, 33136
Contact: Eugene Ahn, MD    305-243-6626    eahn@med.miami.edu   
United States, North Carolina
Duke University Medical Center Not yet recruiting
Durham, North Carolina, United States, 27710
Contact: Linda Sutton, MD         
Wake Forrest Recruiting
Winston, North Carolina, United States, 27157
United States, Ohio
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44106-5065
Contact: Clinical Trials Office - Case Comprehensive Cancer Center    800-641-2422      
Lake/University Ireland Cancer Center Recruiting
Cleveland, Ohio, United States, 44060
Contact: Cynthia Owusu    440-205-5755      
Southwest General Health Center Recruiting
Cleveland, Ohio, United States, 44130
Contact: Cynthia Owusu    440-816-8000      
UHHS Chagrin Highlands Medical Center Recruiting
Cleveland, Ohio, United States, 44122
Contact: Cynthia Owusu    216-292-1783      
UHHS Westlake Medical Center Recruiting
Cleveland, Ohio, United States, 44145
Contact: Cynthia Owusu    440-250-2001      
University Suburban Health Center Recruiting
Cleveland, Ohio, United States, 44121
Contact: Cynthia Owusu    216-844-3871      
UH-Monarch Recruiting
Mayfield Heights, Ohio, United States, 44124
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Principal Investigator: Cynthia Owusu, MD, MSC Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00796978     History of Changes
Other Study ID Numbers: CASE10107, P30CA043703, CASE10107, CASE-10107-CC443
Study First Received: November 21, 2008
Last Updated: September 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Case Comprehensive Cancer Center:
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
HER2-positive breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014