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TerminatedNCT03709082Updated Mar 5, 2024

Palbociclib in Estrogen Receptor Positive (ER+) Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Metastatic Breast Cancer

A Phase 1/2 interventional study of Palbociclib 75mg and Letrozole 2.5mg in HER2-positive Breast Cancer and Breast Cancer Metastatic, sponsored by University of Kansas Medical Center. Terminated at 5 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-05.

Sponsored by University of Kansas Medical Center · Phase 1/2, Interventional, and Treatment

Why this study was terminated
Low accrual

From the registry’s dates

  • Primary completion was Mar 2020, 6 years 6 months ago, and no results have been posted to the registry.
Phase
Phase 1/2
Study type
Interventional
Enrollment
3
Allocation
Non-randomized
Ages
18 Years and older
Sex
Female
01

Study 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 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.

02

Conditions studied

  • HER2-positive Breast Cancer
  • Breast Cancer Metastatic

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Keywords

  • palbociclib
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 3 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

University of Kansas Medical Center is the lead sponsor of 483 studies on the registry; 113 are open to participants now.

Of its 38 completed or terminated interventional studies of FDA-regulated products, 24 (63%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
3 participants (actual)

Study arms

  • Experimental
    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

    Drug: Palbociclib 75mg · Drug: Letrozole 2.5mg · Drug: T-DM1

  • Experimental
    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

    Drug: Letrozole 2.5mg · Drug: T-DM1 · Drug: Palbociclib 100mg

  • Experimental
    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

    Drug: Letrozole 2.5mg · Drug: T-DM1 · Drug: Palbociclib 125mg

  • Experimental
    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

    Drug: Letrozole 2.5mg · Drug: T-DM1 · Drug: Palbociclib

Interventions

  • DrugPalbociclib 75mg

    Oral Administration

    Also known as: Ibrance

  • DrugLetrozole 2.5mg

    Oral Adminstration

    Also known as: Femara

  • DrugT-DM1

    Intravenous Administration

    Also known as: Ado-trastuzumab Emtansine, Kadcyla

  • DrugPalbociclib 100mg

    Oral Administration

    Also known as: Ibrance

  • DrugPalbociclib 125mg

    Oral Administration

    Also known as: Ibrance

  • DrugPalbociclib

    Oral Administration

    Also known as: Ibrance

06

What researchers measure

Primary outcomes

  1. Rate of Overall Response

    Determine overall response rate (ORR), defined per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    Time frame: 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

Secondary outcomes

  1. Proportion of participants with complete response (CR).

    Defined per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    Time frame: Up to 5 years

  2. Proportion of participants with partial response (PR).

    Defined per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    Time frame: Up to 5 years

  3. Proportion of participants with stable disease (SD).

    Defined per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    Time frame: Up to 5 years

  4. Proportion of participants with Grade 3 or higher adverse event.

    Defined per Common Terminology Criteria for Adverse Events (CTCAE) v4.03

    Time frame: Up to 5 years

  5. Number of patients with adverse events

    Determine safety and tolerability of the intervention, defined per Common Terminology Criteria for Adverse Events (CTCAE) v4.03.

    Time frame: Up to 5 years

  6. 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.

    Time frame: At baseline and Day 1 of each cycle, up to 5 years (each cyle is 21 days)

  7. Peak observed plasma concentration

    Defined per maximum observed concentration (Cmax) and time of Cmax (Tmax).

    Time frame: 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)

07

Study locations

5 sites
  • The University of Kansas Cancer Center, West Clinic
    Kansas City, Kansas 66112, United States
  • The University of Kansas Cancer Center, Westwood Campus
    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
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03709082
Lead sponsor
University of Kansas Medical Center
Collaborators
Pfizer
Responsible party
Lauren Nye (Assistant Professor, University of Kansas Medical Center) — Principal investigator
First posted
Oct 17, 2018
Start date
Oct 15, 2018
Primary completion
Mar 12, 2020
Completion
Feb 3, 2021
Last update
Mar 5, 2024

Study contacts

Lauren Nye, MD
principal investigator · KUCC

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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