Trastuzumab in Treating Older Women With Early-Stage Breast Cancer - Full Text View

Sponsors and Collaborators:	Case Comprehensive Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00796978

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	Drug: trastuzumab Procedure: adjuvant therapy Procedure: laboratory biomarker analysis Procedure: quality-of-life assessment	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Trastuzumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Safety and Efficacy of Single Agent Adjuvant Trastuzumab in Older Women With Early Stage Breast Cancer: A Phase II Trial

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Three-year cumulative incidence of cardiac events [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Three-year cumulative incidence of asymptomatic left ventricular cardiac dysfunction [ Designated as safety issue: Yes ]
Mean change in plasma cardiac markers from baseline to mid-treatment and baseline to end of treatment [ Designated as safety issue: No ]
Mean change in pro-inflammatory cytokines from baseline to mid-treatment and baseline to end of 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 [ Designated as safety issue: No ]
Disease-free survival [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]

Estimated Enrollment:	124
Study Start Date:	April 2008
Estimated Primary Completion Date:	November 2015 (Final data collection date for primary outcome measure)

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

Locations

United States, Ohio
Case Comprehensive Cancer Center	Recruiting
Cleveland, Ohio, United States, 44106-5065
Contact: Clinical Trials Office - Case Comprehensive Cancer Center 800-641-2422
Cleveland Clinic Taussig Cancer Center	Recruiting
Cleveland, Ohio, United States, 44195
Contact: Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente 866-223-8100
Geauga Regional Hospital	Recruiting
Cleveland, Ohio, United States, 44024
Contact: Cynthia Owusu 440-285-6000
Lake/University Ireland Cancer Center	Recruiting
Cleveland, Ohio, United States, 44060
Contact: Cynthia Owusu 440-205-5755
University Suburban Health Center	Recruiting
Cleveland, Ohio, United States, 44121
Contact: Cynthia Owusu 216-844-3871
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
Mercy Cancer Center at Mercy Medical Center	Recruiting
Cleveland, Ohio, United States, 44708
Contact: Cynthia Owusu 330-430-2788

Sponsors and Collaborators

Case Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Investigator:	Halle C.F. Moore, MD	The Cleveland Clinic
Study Chair:	Cynthia Owusu, MD, MSC	Case Comprehensive Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Responsible Party:	Case Comprehensive Cancer Center ( Cynthia Owusu )
Study ID Numbers:	CDR0000617454, CASE-10107, CASE-10107-CC443
Study First Received:	November 21, 2008
Last Updated:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00796978
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer

Study placed in the following topic categories:

Skin Diseases
Trastuzumab
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009