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

NCT03709082

Last updated date
Study Location
The University of Kansas Cancer Center, West Clinic
Kansas City, Kansas, 66112, United States
Contact
913-945-7552

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
HER2-positive Breast Cancer, Breast Cancer Metastatic
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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HER2-positive Breast Cancer, Breast Cancer MetastaticPalbociclib in Estrogen Receptor Positive (ER+) Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Metastatic Breast Cancer
NCT03709082
  1. Kansas City, Kansas
  2. Kansas City, Kansas
  3. Overland Park, Kansas
  4. Kansas City, Missouri
  5. Lee's Summit, Missouri
Female
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Palbociclib in Estrogen Receptor Positive (ER+) Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Metastatic Breast Cancer
Official Title  ICMJE A Phase I/II Study of Palbociclib, Letrozole and T-DM1 in Trastuzumab Refractory Estrogen Receptor Positive (ER+) and HER2 Positive Metastatic Breast Cancer
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 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • HER2-positive Breast Cancer
  • Breast Cancer Metastatic
Intervention  ICMJE
  • Drug: Palbociclib 75mg
    Oral Administration
    Other Name: Ibrance
  • Drug: Letrozole 2.5mg
    Oral Adminstration
    Other Name: Femara
  • Drug: T-DM1
    Intravenous Administration
    Other Names:
    • Ado-trastuzumab Emtansine
    • Kadcyla
  • Drug: Palbociclib 100mg
    Oral Administration
    Other Name: Ibrance
  • Drug: Palbociclib 125mg
    Oral Administration
    Other Name: Ibrance
  • Drug: Palbociclib
    Oral Administration
    Other Name: Ibrance
Study Arms  ICMJE
  • 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
    Interventions:
    • 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
    Interventions:
    • 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
    Interventions:
    • 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
    Interventions:
    • Drug: Letrozole 2.5mg
    • Drug: T-DM1
    • Drug: Palbociclib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 23, 2020)
3
Original Estimated Enrollment  ICMJE
 (submitted: October 15, 2018)
62
Estimated Study Completion Date  ICMJE October 15, 2025
Actual Primary Completion Date March 12, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Gender Based Eligibility:Yes
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03709082
Other Study ID Numbers  ICMJE 2017-IIT-HER2-Aspire
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party University of Kansas Medical Center
Study Sponsor  ICMJE University of Kansas Medical Center
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Lauren Nye, MDKUCC
PRS Account University of Kansas Medical Center
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP