Clinical trial · Interventional
A Study of Trastuzumab Emtansine in Patients With HER2-Positive Metastatic Breast Cancer and Normal or Reduced Hepatic Function
A Phase I, Open Label, Parallel Group, Pharmacokinetic Study of Trastuzumab Emtansine in Patients With HER2-Positive Metastatic Breast Cancer and Normal or Reduced Hepatic Function
- 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 open-label, parallel group study will evaluate the pharmacokinetics and safety of trastuzumab emtansine in patients with HER2-positive metastatic breast cancer and normal or reduced hepatic function. Patients will receive trastuzumab emtansine intravenously on Day 1 of each 3-week cycle. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| trastuzumab emtansine | Drug | Trastuzumab Emtansine | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Mild hepatic dysfunction
- interventionNames
- Drug: trastuzumab emtansine
- type
- EXPERIMENTAL
- label
- Moderate hepatic dysfunction
- interventionNames
- Drug: trastuzumab emtansine
- type
- EXPERIMENTAL
- label
- Normal hepatic function
- interventionNames
- Drug: trastuzumab emtansine
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients, \>/= 18 years of age * Histologically or cytologically documented invasive metastatic breast cancer * Human epidermal growth factor receptor 2 (HER2) -positive disease * Adequate bone marrow and organ function (other than hepatic dysfunction allowed by protocol) * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 * Left ventricular ejection fraction \>/=50% * Normal hepatic function, or mild to moderate hepatic impairment (Child-Pugh Class A or B) Exclusion Criteria: * History of Grade \>/=3 infusion reaction, hypersensitivity reaction, or pneumonitis in response to trastuzumab * Investigational therapy or any other anticancer therapy \</=28 days before first study treatment * Previous treatment with trastuzumab emtansine * Brain metastases that are untreated or symptomatic or require therapy to control symptoms or any radiation, surgery or other therapy to control symptoms from brain metastases within 1 month of the first study treatment * History of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other cancers with a similar outcome as those mentioned above * Current peripheral neuropathy of Grade \>/=2 * Child-Pugh Class C hepatic impairment * Encephalopathy \>/= Grade 2 * For patients with normal hepatic function: history of drug or alcohol addiction or history of hepatitis B and/or hepatitis C * Active hepatitis A, B and/or C * Current unstable ventricular arrhythmia requiring treatment * History of symptomatic CHF (NYHA Classes II-IV) * History of myocardial infarction or unstable angina within 6 months of enrollment * History of a decrease in LVEF to\<40% or symptomatic CHF with previous trastuzumab treatment * Pregnant or lactating women * Known HIV infection
References
Publications (0)
Data not yet available