Clinical trial · Interventional
Trastuzumab in Treating Older Women With Early-Stage Breast Cancer
Safety and Efficacy of Single Agent Adjuvant Trastuzumab (Herceptin®) in Older Women With Early-Stage and Locally Advanced Breast Cancer: A Phase II Trial
NCT00796978CI-TRIAL-00076634completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| trastuzumab | Biological | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- trastuzumab
- interventionNames
- Biological: trastuzumab
- Other: laboratory biomarker analysis
- Procedure: adjuvant therapy
- Procedure: quality-of-life assessment
Primary outcomes (1)
- measure
- Percent of Participants Experiencing Cardiac Events at 1 Year
- timeFrame
- At 1 year
- description
- Number of participants that experience cardiac events that include cardiac death due to congestive heart failure (CHF), Myocardial infarction (MI) or documented arrhythmia, death without definitive cause, or signs and symptoms of CHF as defined by New York Heart Association (NYHA) class III or IV symptoms.
Secondary outcomes (29)
- measure
- Percent of Participants Experiencing Cardiac Events at 3 Years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 60 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.