Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments trastuzumab, laboratory biomarker analysis, adjuvant therapy, quality-of-life assessment
Phase phase 2
Target HER2
Sponsor Cynthia Owusu, MD
Collaborator National Cancer Institute (NCI)
Start date November 2008
End date November 2015
Trial size 56 participants
Trial identifier NCT00796978, CASE-10107-CC443, CASE10107, P30CA043703

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
trastuzumab 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 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.

Primary Outcomes

Measure
Three-year cumulative incidence of cardiac events
time frame: every 6 weeks during treatment up to one year

Secondary Outcomes

Measure
Three-year cumulative incidence of asymptomatic left ventricular cardiac dysfunction
time frame: every 6 weeks during treatment up to one year
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 one year
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 one year
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.

Eligibility Criteria

Female participants at least 65 years old.

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

Additional Information

Official title Safety and Efficacy of Single Agent Adjuvant Trastuzumab in Older Women With Early Stage Breast Cancer: A Phase II Trial
Principal investigator Cynthia Owusu, MD, MSC
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Case Comprehensive Cancer Center.