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Safety and Efficacy of Single Agent Adjuvant Trastuzumab in Older Women With Early Stage Breast Cancer: A Phase II Trial


Phase 2
65 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Safety and Efficacy of Single Agent Adjuvant Trastuzumab in Older Women With Early Stage Breast Cancer: A Phase II Trial


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Three-year cumulative incidence of cardiac events

Outcome Time Frame:

every 6 weeks during treatment

Safety Issue:

Yes

Principal Investigator

Cynthia Owusu, MD, MSC

Investigator Role:

Principal Investigator

Investigator Affiliation:

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CASE10107

NCT ID:

NCT00796978

Start Date:

November 2008

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • HER2-positive breast cancer
  • Breast Neoplasms

Name

Location

Lake/University Ireland Cancer CenterMentor, Ohio  44060
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
University of PittsburghPittsburgh, Pennsylvania  15261
Duke University Medical CenterDurham, North Carolina  27710
UH-MonarchMayfield Heights, Ohio  44124
Southwest General Health CenterMiddleburgh Heights, Ohio  44130
UHHS Chagrin Highlands Medical CenterOrange Villager, Ohio  44122
University Suburban Health CenterSouth Euclid, Ohio  44121
UHHS Westlake Medical CenterWestlaker, Ohio  44145
University of Miami, Sylvester Comprehensive Cancer CenterMiami, Florida  33136
Wake ForrestWinston, North Carolina  27157