A Phase Ib-IIa, Open-label, Dose-Escalation Study of the Safety, Tolerability and Pharmacokinetics of Trastuzumab Emtansine, Paclitaxel and Pertuzumab Administered Intravenously to Patients With Her2-positive, Locally Advanced or Metastatic Breast Cancer
This Phase Ib-IIa, multi-institutional, open-label, dose-escalation study is designed to evaluate the safety, tolerability, pharmacokinetics and feasibility of trastuzumab emtansine (T-DM1) administered by intravenous (IV) infusion in combination with paclitaxel (and pertuzumab, if applicable) in patients with human epidermal growth factor receptor 2-positive (HER2-positive), locally advanced or metastatic breast cancer.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : paclitaxel
- drug : trastuzumab emtansine [Kadcyla]
- drug : pertuzumab [Perjeta]
Phase: Phase 1/Phase 2
Ages Eligible For Study:
- Histologically documented HER2-positive locally advanced or metastatic breast cancer - Tumor tissue blocks or 15-20 unstained tissue slides for confirmatory central laboratory HER2 status testing and other exploratory assessments - Prior trastuzumab in any line of therapy (Phase Ib patients only) - No prior T-DM1 or pertuzumab therapy - Measurable or evaluable disease - Cardiac ejection fraction >=50% by either echocardiogram or multigated acquisition scan - Life expectancy >= 90 days as assessed by the investigator