Palbociclib in Estrogen Receptor Positive (ER+) Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Metastatic Breast Cancer
NCT ID: NCT03709082
Last Updated: 2024-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1/PHASE2
3 participants
INTERVENTIONAL
2018-10-15
2021-02-03
Brief Summary
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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 2.5mg PO will be administered daily for each 21 day cycle and T-DM1 3.6 milligrams per kilograms intravenously (IV) will be administered on Day 1 of each 21 day cycle.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Phase 1: Palbociclib 75 mg
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 75mg
Oral Administration
Letrozole 2.5mg
Oral Adminstration
T-DM1
Intravenous Administration
Phase 1: Palbociclib 100 mg
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
Letrozole 2.5mg
Oral Adminstration
T-DM1
Intravenous Administration
Palbociclib 100mg
Oral Administration
Phase 1: Palbociclib 125 mg
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
Letrozole 2.5mg
Oral Adminstration
T-DM1
Intravenous Administration
Palbociclib 125mg
Oral Administration
Phase 2: RP2D
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
Letrozole 2.5mg
Oral Adminstration
T-DM1
Intravenous Administration
Palbociclib
Oral Administration
Interventions
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Palbociclib 75mg
Oral Administration
Letrozole 2.5mg
Oral Adminstration
T-DM1
Intravenous Administration
Palbociclib 100mg
Oral Administration
Palbociclib 125mg
Oral Administration
Palbociclib
Oral Administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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Pfizer
INDUSTRY
University of Kansas Medical Center
OTHER
Responsible Party
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Lauren Nye
Assistant Professor
Principal Investigators
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Lauren Nye, MD
Role: PRINCIPAL_INVESTIGATOR
KUCC
Locations
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The University of Kansas Cancer Center, West Clinic
Kansas City, Kansas, United States
The University of Kansas Cancer Center, Westwood Campus
Kansas City, Kansas, United States
The University of Kansas Cancer Center, Overland Park Clinic
Overland Park, Kansas, United States
The University of Kansas Cancer Center, North Clinic
Kansas City, Missouri, United States
The University of Kansas Cancer Center, Lee's Summit Clinic
Lee's Summit, Missouri, United States
Countries
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Other Identifiers
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2017-IIT-HER2-Aspire
Identifier Type: -
Identifier Source: org_study_id
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