Phase 2
Completed N=56
Trastuzumab in Treating Older Women With Early-Stage Breast Cancer
Source: ClinicalTrials.gov NCT00796978 ↗Enrolled (actual)
56
Serious AEs
14.3%
Results posted
Aug 2020
Primary outcomePrimary: Percent of Participants Experiencing Cardiac Events at 1 Year — 3.6 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Participants Experiencing Cardiac Events at 1 Year |
3.6 | — |
| SECONDARY Percent of Participants Experiencing Cardiac Events at 3 Years |
— | — |
| SECONDARY Percent of Participants Experiencing Cardiac Events at 5 Years |
— | — |
| SECONDARY Percent of Participants of Asymptomatic Left Ventricular (LV) Cardiac Dysfunction at 1 Year |
9.1 | — |
| SECONDARY Percent of Participants With Asymptomatic LV Cardiac Dysfunction at Three Years |
— | — |
| SECONDARY Percent of Participants With Asymptomatic LV Cardiac Dysfunction at Five Years |
— | — |
| SECONDARY Percent of Participants With Disease-free Survival (DFS) |
86.4 | — |
| SECONDARY Percent of Participants With DFS |
94.47 | — |
| SECONDARY Overall Survival (OS) as Measured by Percent of Participants Alive at 1 Year |
100.0 | — |
| SECONDARY Overall Survival (OS) as Measured by Percent of Participants Alive at 2 Years |
100.0 | — |
| SECONDARY Overall Survival (OS) as Measured by Percent of Participants Alive at 3 Years |
94.23 | — |
| SECONDARY Overall Survival (OS) as Measured by Percent of Participants Alive at 5 Years |
90.2 | — |
| SECONDARY Mean Change in Quality of Life From Baseline to Mid-treatment |
-2.8 | — |
| SECONDARY Mean Change in Quality of Life From Baseline to End of Treatment |
-9.2 | — |
| SECONDARY Mean Change in Functional Status |
-0.26 | — |
| SECONDARY Mean Change in Cognitive Status |
-0.59 | — |
| SECONDARY Mean Change in Psychosocial Status (Depression) |
-0.39 | — |
| SECONDARY Mean Change in Psychosocial Status (Social Support) |
-7.53 | — |
| SECONDARY Mean Change in Nutritional Status |
-0.39 | — |
| SECONDARY Mean Change in Pro-inflammatory Cytokines |
NA | — |
| SECONDARY Mean Change in Plasma Cardiac Markers |
NA | — |
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 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
Data sourced from ClinicalTrials.gov (NCT00796978). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.