Trastuzumab in Treating Older Women With Early-Stage Breast Cancer

NCT ID: NCT00796978

Last Updated: 2024-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-05
• Study Completion Date: 2020-02-26

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

trastuzumab

Group Type: EXPERIMENTAL

trastuzumab

Intervention Type: BIOLOGICAL

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

Intervention Type: OTHER

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

Intervention Type: PROCEDURE

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

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: BIOLOGICAL

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).

Intervention Type: OTHER

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

Herceptin

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cynthia Owusu, MD

OTHER

Sponsor Role: lead

Responsible Party

Cynthia Owusu, MD

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Cynthia Owusu, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Locations

University of Miami, Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Wake Forrest

Winston-Salem, North Carolina, United States

Lake/University Seidman Cancer Center

Cleveland, Ohio, United States

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

University Suburban Health Center

Cleveland, Ohio, United States

UHHS Chagrin Highlands Medical Center

Cleveland, Ohio, United States

Southwest General Health Center

Cleveland, Ohio, United States

UHHS Westlake Medical Center

Cleveland, Ohio, United States

UH-Monarch

Mayfield Heights, Ohio, United States

Sharon Health Center

Wadsworth, Ohio, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

CASE10107

Identifier Type: -

Identifier Source: org_study_id