Study of CR011-vcMMAE to Treat Locally Advanced or Metastatic Breast Cancer
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This study will evaluate the safety and tolerability of CR011-vcMMAE in patients with locally advanced and metastatic breast cancer. CR011-vcMMAE will be administered intravenously (IV) once every 3 weeks (q3w) to cohorts of 3-6 patients to confirm the maximum tolerated dose (MTD) in breast cancer patients. Once the MTD is confirmed, up to 25 patients with locally advanced or metastatic breast cancer will be enrolled into the Phase II portion of the trial to further evaluate the safety and efficacy of CR011-vcMMAE.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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