Trastuzumab in Treating Older Women With Early-Stage Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: trastuzumab; laboratory biomarker analysis; adjuvant therapy; quality-of-life assessment
Intervention description: 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 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.; 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 MeSH terms: Trastuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 56.0
Sex: Female
Minimum age: 60 Years
Healthy volunteers: No
Keywords: stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; HER2-positive breast cancer

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.
    

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