Clinical trial · Observational
A Study to Determine the Safety and Tolerability of Herceptin as an Adjuvant Therapy of Early Breast Cancer
NCT02443467CI-TRIAL-00024703completedClinicalTrials.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)
This was an open-labeled, multi-center, prospective, non-comparative study of the safety of Herceptin (trastuzumab) used as an adjuvant therapy in patients with early breast cancer who had previously received antracycline therapy before or after surgery.
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, Early Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- HER2-positive early breast cancer
- description
- Human Epidermal Growth Factor Receptor 2 (HER2)-positive early breast cancer treated with loading dose of Herceptin (trastuzumab) administered as 6 mg/kg followed by once in 3 weeks administration at 4 mg/kg up to 12 months of treatment
- interventionNames
- Other: No intervention
Primary outcomes (2)
- measure
- Percentage of participants with adverse events
- timeFrame
- Up to 3 years
- measure
- Percentage of participants with serious adverse events
- timeFrame
- Up to 3 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female patients \> or = 18 years of age * Human Epidermal Growth Factor Receptor 2 (HER2)-neu overexpression * Previously treated with adjuvant antracycline containing chemotherapy * Left Ventricular Ejection Fraction (LVEF) \> 50% * Eastern Cooperative Oncology Group (ECOG) score \< or = 2 * Life expectancy \> or = 12 weeks Exclusion Criteria: * Left Ventricular Ejection Fraction (LVEF) \< 50% * Advanced pulmonary disease * Severe dyspnea * Abnormal laboratory results within 14 days prior to registration * Peripheral neuropathy * Presence of Central Nervous System (CNS) metastasis
References
Publications (0)
Data not yet available
No reference posted for this study.