T-DM1 and Palbociclib for Metastatic HER2 Breast Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Breast Cancer
- Breast Cancer Stage
- HER2 Positive Breast Carcinoma
- HER2 Positive Breast Cancer
- Metastatic Breast Cancer
- Recurrent Breast Cancer
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This is a multi-center, randomized, phase II study of T-DM1 with or without palbociclib in the treatment of patients with metastatic HER2-positive breast cancer. Patients will be randomized 1:1 to T-DM1 with or without palbociclib. Hypotheses: Combination of T-DM1 with palbociclib improves progressi...
This is a multi-center, randomized, phase II study of T-DM1 with or without palbociclib in the treatment of patients with metastatic HER2-positive breast cancer. Patients will be randomized 1:1 to T-DM1 with or without palbociclib. Hypotheses: Combination of T-DM1 with palbociclib improves progression free survival compared to single agent T-DM1 Primary objective: Compare progression free survival of the combination arm (T-DM1 with palbociclib) to single agent T-DM1 Secondary objectives i) Compare response rates between both treatment arms ii) Compare overall survival between both treatment arms Correlative objectives i) Investigate predictive biomarkers of response in blood and archived tumor tissue ii) Investigate mechanisms of resistance for palbociclib in blood and tumor tissue
Tracking Information
- NCT #
- NCT03530696
- Collaborators
- Pfizer
- Investigators
- Principal Investigator: Pavani Chalasani, MD The University of Arizona Cancer Center
Get Well Soon