Phase II Study of CT-2103 in Patients With Metastatic Breast Cancer
- Patients will be given CT-2103 intravenously every 3 weeks. One week after the first
dose of CT-2103 a physical exam, blood work and assessment of any side effects will be
- Prior to each injection of CT-2103, a physical exam, blood work and assessment of any
side effects will be performed (every 3 weeks).
- Every 6 weeks the patient's cancer will be re-evaluated with either a CT scan or MRI to
determine whether the treatment is working.
- Additional blood work will be performed once per week after the first two doses of
- The participation in this study will last at least 2 cycles (6 weeks), however patients
may remain on the study as long as there is no disease progression, and they are able
to tolerate the study drug without severe side effects.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the response to CT02103 as first or second-line treatment in patients with metastatic breast cancer.
Lawrence N. Shulman, MD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|