A Phase I/II Study of CR011-vcMMAE in Patients With Locally Advanced or Metastatic Breast Cancer
Main
Inclusion Criteria:
- Females with confirmed breast cancer
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2
- Locally advanced or metastatic disease who have received at least two prior
chemotherapeutic regimens for breast cancer, as follows:
- At least one regimen must have been for locally advanced or metastatic disease
- Subject must have received an anthracycline, a taxane, and capecitabine in any
combination unless the subject was intolerant to or not a candidate for any of
these agents
- Hormonal therapy, biologic therapy (such as trastuzumab or bevacizumab), or
immunotherapy do not count as one of the 2 regimens
- Subjects with HER2/neu overexpressing tumors must have been treated with
trastuzumab except in situations where the subject was intolerant to or not a
candidate for trastuzumab
- Documented progressive disease within 6 months of the last regimen
- Adequate bone marrow, renal and liver function
- Signed informed consent
Main Exclusion Criteria:
- Chemotherapy, radiation, hormonal therapy, or bevacizumab within two weeks, or
trastuzumab or investigational therapy within three weeks before treatment start
- Neuropathy > NCI-CTCAE Grade 1
- Active brain metastases.
- New York Heart Association class III or IV heart disease
- Unstable angina
- Uncontrolled arrhythmia
- A marked baseline prolongation of QT/QTc interval
- Pregnant or breast-feeding women, and women of childbearing age and potential who are
not willing to use effective contraception