Status:
COMPLETED
A Study of Trastuzumab Emtansine in Patients With HER2-Positive Metastatic Breast Cancer and Normal or Reduced Hepatic Function
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 funct...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01513083
Start Date
February 1 2012
End Date
September 1 2014
Last Update
November 2 2016
Active Locations (13)
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1
Fort Myers, Florida, United States, 33905
2
Detroit, Michigan, United States, 48201
3
Portland, Oregon, United States, 97239
4
Nashville, Tennessee, United States, 37203