Ignite Creation Date:
2024-05-06 @ 12:13 PM
Last Modification Date:
2024-10-26 @ 12:56 PM
Study NCT ID:
NCT03709082
Status:
TERMINATED
Last Update Posted:
2024-03-05
First Post:
2018-10-09
Brief Title:
Palbociclib in Estrogen Receptor Positive ER Human Epidermal Growth Factor Receptor 2 Positive HER2 Metastatic Breast Cancer
Sponsor:
University of Kansas Medical Center
Organization:
University of Kansas Medical Center
Study Overview
Official Title:
A Phase III Study of Palbociclib Letrozole and T-DM1 in Trastuzumab Refractory Estrogen Receptor Positive ER and HER2 Positive Metastatic Breast Cancer
Status:
TERMINATED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will determine the recommend dose of palbociclib in combination with letrozole and another medication Ado-trastuzumab emtansine T-DM1 Additionally researchers will determine how well this recommended dose will improve outcomes in this type of advanced breast cancer
The study will include a safety lead-in with escalating dosing of palbociclib to determine the recommended phase II dose RP2D of palbociclib in this combination and an expanded phase II of palbociclib at the RP2D in combination with letrozole and Ado- trastuzumab Emtansine T-DM1
The starting dose of palbociclib will be 75 milligrams mg by mouth PO daily for each 21 day cycle If 0 of 3 patients at the 75mg dose level experience a dose limiting toxicity DLT the next 3 patients will be enrolled at the next higher dosing cohort of 100mg PO daily for each 21 day cycle If 0 of 3 patients at the 100mg dose level experience a DLT the next 3 patients will be enrolled at the next higher dosing cohort of 125mg PO daily for each 21 day cycle If 0 of 3 patients at the 125mg dose level experience a DLT 125mg PO daily of palbociclib will be the phase II recommended dose used in the phase II expanded cohort Patients receiving the phase II recommended dose in phase I will be enrolled in phase II of the study
During safety lead-in and expanded phase II Letrozole 25mg PO will be administered daily for each 21 day cycle and T-DM1 36 milligrams per kilograms intravenously IV will be administered on Day 1 of each 21 day cycle
The study will include a safety lead-in with escalating dosing of palbociclib to determine the recommended phase II dose RP2D of palbociclib in this combination and an expanded phase II of palbociclib at the RP2D in combination with letrozole and Ado- trastuzumab Emtansine T-DM1
The starting dose of palbociclib will be 75 milligrams mg by mouth PO daily for each 21 day cycle If 0 of 3 patients at the 75mg dose level experience a dose limiting toxicity DLT the next 3 patients will be enrolled at the next higher dosing cohort of 100mg PO daily for each 21 day cycle If 0 of 3 patients at the 100mg dose level experience a DLT the next 3 patients will be enrolled at the next higher dosing cohort of 125mg PO daily for each 21 day cycle If 0 of 3 patients at the 125mg dose level experience a DLT 125mg PO daily of palbociclib will be the phase II recommended dose used in the phase II expanded cohort Patients receiving the phase II recommended dose in phase I will be enrolled in phase II of the study
During safety lead-in and expanded phase II Letrozole 25mg PO will be administered daily for each 21 day cycle and T-DM1 36 milligrams per kilograms intravenously IV will be administered on Day 1 of each 21 day cycle
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None