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A phase Ib, open-label, dose-escalation study of the safety, tolerability and pharamacokinetics of Trastuzumab-MMC-DM1, Paclitaxel, and Pertuzumab administered intravenously to patients with HER2-Positive, locally advanced or metastatic breast cancer who have previously received a Trastuzumab-containing regimen
- This is a clinical trial of an investigational agent, TDM-1, that will be administered IV in combination with paclitaxel with or without pertuzumab given in various schedules depending on the enrollment group assigned.
- IRB Protocol Number
- Principal Investigator(s)
- ANTHONY ELIAS
- MEGHAN HOULIHAN at 720-848-1156
- Eligibility and Other Participant Information
- What To Expect : A screening period to determine eligibility that includes but is not limited to doctors visits, labs, and scans. A treatment period that can last up to 1 year with an option to continue to receive study medication on and extension study if there is still benefit. On treatment chemotherapy is either given either or once every 21 days depending on the enrollment group. Disease evaluations are performed every other cycle. Additional blood samples are taken during the first two months of treatment for study purposes only. A follow up period will consist of clinic visits every 6 weeks until the disease worsens or the patient starts another cancer therapy. // Eligibility criteria include but are not limited to people 18 years or older with diagnosed with HER2 positive metastatic breast cancer that have previously received Herceptin (trastuzumab) for treatment of their breast cancer.