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Low accrual
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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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 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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1: Palbociclib 75 mg | Experimental | 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 |
|
| Phase 1: Palbociclib 100 mg | Experimental | 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 |
|
| Phase 1: Palbociclib 125 mg | Experimental | 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 |
|
| Phase 2: RP2D | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palbociclib 75mg | Drug | Oral Administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Overall Response | Determine overall response rate (ORR), defined per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 | From the time of first documented complete response or appearance of one or more new lesions, until the first documented date of recurrent or progressive disease, whichever came first, assessed up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with complete response (CR). | Defined per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 | Up to 5 years |
| Proportion of participants with partial response (PR). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lauren Nye, MD | KUCC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Kansas Cancer Center, West Clinic | Kansas City | Kansas | 66112 | United States | ||
| The University of Kansas Cancer Center, Westwood Campus |
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| Letrozole 2.5mg | Drug | Oral Adminstration |
|
|
| T-DM1 | Drug | Intravenous Administration |
|
|
| Palbociclib 100mg | Drug | Oral Administration |
|
|
| Palbociclib 125mg | Drug | Oral Administration |
|
|
| Palbociclib | Drug | Oral Administration |
|
|
Defined per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
| Up to 5 years |
| Proportion of participants with stable disease (SD). | Defined per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 | Up to 5 years |
| Proportion of participants with Grade 3 or higher adverse event. | Defined per Common Terminology Criteria for Adverse Events (CTCAE) v4.03 | Up to 5 years |
| Number of patients with adverse events | Determine safety and tolerability of the intervention, defined per Common Terminology Criteria for Adverse Events (CTCAE) v4.03. | Up to 5 years |
| Number of participants with a worsening Patient Reported Outcomes of Adverse Events (PRO-AE) score | PRO-AE score defined per Patient Reported Outcome Measurement Information System (PROMIS) and Breast Cancer Prevention Trial (BCPT) Symptom Checklist. | At baseline and Day 1 of each cycle, up to 5 years (each cyle is 21 days) |
| Peak observed plasma concentration | Defined per maximum observed concentration (Cmax) and time of Cmax (Tmax). | Cycle 1, Day 1: 0 ,2,4 and 8 hours post treatment; Cycle 1, Day 15: 0 hours post treatment (each cyle is 21 days) |
| Kansas City |
| Kansas |
| 66205 |
| United States |
| The University of Kansas Cancer Center, Overland Park Clinic | Overland Park | Kansas | 66210 | United States |
| The University of Kansas Cancer Center, North Clinic | Kansas City | Missouri | 64154 | United States |
| The University of Kansas Cancer Center, Lee's Summit Clinic | Lee's Summit | Missouri | 64064 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 27, 2026 | Feb 12, 2026 | 6 |
| ID | Term |
|---|---|
| C500026 | palbociclib |
| D000077289 | Letrozole |
| D000080044 | Ado-Trastuzumab Emtansine |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D008453 | Maytansine |
| D018942 | Macrolides |
| D007783 | Lactones |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D000068878 | Trastuzumab |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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