Breast Cancer
Conditions
Keywords
CR011-vcMMAE, locally advanced breast cancer, metastatic breast cancer, breast cancer, CuraGen
Brief summary
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.
Interventions
DRUGCR011-vcMMAE
administered as an intravenous infusion on Day 1 of a 21 day cycle.
Sponsors
CuraGen Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of CR011-vcMMAE in breast cancer patients | throughout the study |
| To determine the MTD of CR011-vcMMAE in breast cancer patients | throughout the study |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of efficacy (progression-free survival rate at 12 weeks, objective response rate, time to response, duration of response and time to progression) | throughout the study |
Countries
United States
Outcome results
None listed