Palbociclib in Estrogen Receptor Positive (ER+) Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Metastatic Breast Cancer
HER2-positive Breast Cancer, Breast Cancer Metastatic
About this trial
This is an interventional treatment trial for HER2-positive Breast Cancer focused on measuring palbociclib
Eligibility Criteria
Inclusion Criteria:
- Pathologically confirmed diagnosis of Estrogen Receptor (ER) positive and HER2 (human epidermal growth factor receptor 2) positive metastatic breast cancer based on local laboratory results.
- Prior treatment with a taxane (including paclitaxel, docetaxel and/or nanoparticle protein-bound paclitaxel).
- Prior treatment with trastuzumab with or without pertuzumab.
- Measurable or non-measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1.
- Eastern Cooperative Oncology Group Performance Status of 0-2
- Adequate organ and marrow function
- Women must be post-menopausal
- Must be able to swallow pills
Exclusion Criteria:
- Current or anticipated use of other investigational agents
- Prior therapy with a cyclin-dependent kinase 4/6 inhibitor
- Subject has received chemotherapy or radiotherapy within 14 days prior to Cycle 1, Day 1 of the study or has not recovered from adverse events due to agents administered more than 14 days earlier
- Subject has leptomeningeal disease
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to palbociclib or other agents used in study
- Subject has other illness or disease that the investigator believes will interfere with study requirements.
Sites / Locations
- The University of Kansas Cancer Center, West Clinic
- The University of Kansas Cancer Center, Westwood Campus
- The University of Kansas Cancer Center, Overland Park Clinic
- The University of Kansas Cancer Center, North Clinic
- The University of Kansas Cancer Center, Lee's Summit Clinic
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Phase 1: Palbociclib 75 mg
Phase 1: Palbociclib 100 mg
Phase 1: Palbociclib 125 mg
Phase 2: RP2D
Palbociclib 75 milligrams (mg) by mouth (PO) daily Letrozole 2.5 mg PO Daily Ado-trastuzumab Emtansine (T-DM1) 3.6 milligrams per kilograms (mg/kg) intravenous (IV) Day 1
Palbociclib 100 milligrams (mg) by mouth (PO) daily Letrozole 2.5 mg PO Daily Ado-trastuzumab Emtansine (T-DM1) 3.6 milligrams per kilograms (mg/kg) intravenous (IV) Day 1
Palbociclib 125 milligrams (mg) by mouth (PO) daily Letrozole 2.5 mg PO Daily Ado-trastuzumab Emtansine (T-DM1) 3.6 milligrams per kilograms (mg/kg) intravenous (IV) Day 1
Recommended Phase 2 dose (RP2D; determined during Phase 1 Safety Run In) Palbociclib by mouth (PO) daily Letrozole 2.5 mg PO Daily Ado-trastuzumab Emtansine (T-DM1) 3.6 milligrams per kilograms (mg/kg) intravenous (IV) Day 1