At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Histologically confirmed stage II or III primary adenocarcinoma of the breast
- ✓HER2 overexpression or gene amplification documented by validated approved method
- ✓Completion of neoadjuvant or adjuvant chemotherapy prior to enrollment
- ✕Clinical or radiologic evidence of metastatic disease
- ✕Currently receiving chemotherapy, radiation therapy, investigational immunotherapy, or biotherapy for breast cancer
- ✕Major surgery (including breast surgery) within <30 days or prior cancer therapy <14 days before initiating study treatment
- ✕Active uncontrolled cardiac disease, cardiomyopathy, congestive heart failure (NYHA ≥2), unstable angina, MI within 12 months, or ventricular arrhythmia
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open Label Study to Characterize the Incidence and Severity of Diarrhea in Patients With HER2+ Breast Cancer Treated With Neratinib With or Without Trastuzumab
In Brief
A Phase 2 clinical trial evaluating Neratinib, Trastuzumab, and 3 other interventions for HER2-positive Breast Cancer and 8 related conditions. Completed, enrolled 11 participants across 1 site.
Detailed Summary
This phase II trial studies the incidence and severity of diarrhea in patients with stage II-IIIC HER2 Positive breast cancer treated with trastuzumab and neratinib. Trastuzumab is a form of targeted therapy because it attaches itself to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by the body's immune system. Neratinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving trastuzumab and neratinib may work better in treating patients with stage II-IIIC HER2 positive breast cancer.
Study Details
Timeline
Interventions
Given orally (PO)
Given Intravenously (IV)
Given PO
Given PO
Allowed for participants experiencing refractory diarrhea