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T-DM1 and Palbociclib for Metastatic HER2 Breast Cancer

Sponsor
University of Arizona (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03530696
Collaborator
Pfizer (Industry)
46
Enrollment
16
Locations
1
Arm
71.9
Anticipated Duration (Months)
2.9
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a single arm, phase II study to evaluate if the combination of T-DM1 with palbociclib improves progression-free survival in patients with metastatic HER2 positive breast cancer. All patients will be treated with T-DM1 with palbociclib.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

This is a multi-center, single arm, phase II study of T-DM1 with or without palbociclib in the treatment of patients with metastatic HER2-positive breast cancer.

Hypotheses: Combination of T-DM1 with palbociclib improves progression free survival

Primary objective: Progression free survival of the combination of T-DM1 with palbociclib

Secondary objectives i) Response rates ii) Overall survival

Correlative objectives i) Investigate predictive biomarkers of response in blood and archived tumor tissue ii) Investigate mechanisms of resistance for palbociclib in blood and tumor tissue

Study Design

Study Type:
Interventional
Anticipated Enrollment :
46 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Single Arm Phase II Study to Evaluate Efficacy of T-DM1 With Palbociclib in the Treatment of Patients With Metastatic HER2 Positive Breast Cancer
Actual Study Start Date :
Dec 6, 2018
Anticipated Primary Completion Date :
Dec 22, 2022
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: T-DM1 with palbociclib

T-DM1 is given IV every 21 days Palbociclib is administered days 5-18

Drug: Palbociclib
Compare progression free survival of the combination arm (T-DM1 with palbociclib) to single agent T-DM1
Other Names:
  • Ibrance

    • Drug: T-DM1
    Compare progression free survival of the combination arm (T-DM1 with palbociclib) to single agent T-DM1
    Other Names:
  • Kadcyla

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Compare progression-free survival [4 years]

      Compare progression-free survival of the combination arm (T-DM1 with palbociclib) to single agent T-DM1

    Secondary Outcome Measures

    1. Compare response rates [4 years]

      Compare response rates between both treatment arms

    2. Compare overall survival [4 years]

      Compare overall survival between both treatment arms

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Be informed of the investigational nature of the study and all pertinent aspects of the trial

    2. Sign and provide written consent in accordance with institutional and federal guidelines.

    3. ECOG Performance status of 0-2

    4. Recurrent or metastatic HER2-positive breast cancer (HER2 positive is defined per ASCO-CAP guidelines)

    5. Adequate cardiac reserve (EF≥50%)

    6. Serum creatinine ≤ 1.5 x institutional upper limit of normal (IULN), bilirubin ≤ 2.0, and an SGOT/SGPT/alkaline phosphatase ≤ 2.0 x IULN

    7. Adequate bone marrow function (ANC ≥1000, Platelets ≥100,000/ml, Hemoglobin ≥10gm/dL)

    8. Be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other trial procedures

    9. Been treated with pertuzumab previously (neoadjuvant or metastatic setting). Patients who weren't able to tolerate pertuzumab due to side effects can be eligible for study upon discussion with the study PI

    10. No more than 2 lines of therapy in the metastatic disease setting

    Exclusion Criteria:

    1. HER2 negative tumors

    2. Prior treatment with T-DM1

    3. Prior treatment with CDK 4/6 inhibitors

    4. Known active CNS metastases or carcinomatous meningitis. Patients with stable CNS metastases including brain metastases who have completed a course of radiotherapy are eligible for the study provided they are clinically stable. However, oral corticosteroids for control of CNS symptoms are not allowed on study

    5. Known documented or suspected hypersensitivity to the components of the study drug(s) or analogs.

    6. Uncontrolled systemic illness, including but not limited to ongoing or active infection

    7. Symptomatic congestive heart failure, unstable angina pectoris, stroke or myocardial infarction within 3 months

    8. Be pregnant or breast feeding. Female subjects must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy. All female subjects with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrollment and must agree to use effective contraception during the period of therapy

    9. Concurrent hormonal or other anti-neoplastic therapy is not allowed. Patients can receive supportive therapy like bone-directed therapy including bisphosphonates or denosumab

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Arizona Cancer Center Tucson Arizona United States 85724
    2 Cedar-Sinai Beverly Hills California United States 90048
    3 University of Colorado Denver Aurora Colorado United States 80045
    4 Yale Cancer Center New Haven Connecticut United States 06519
    5 Johns Hopkins Hospital Baltimore Maryland United States 21287
    6 Mosaic Life Care Saint Joseph Missouri United States 65406
    7 University of New Mexico Albuquerque New Mexico United States 87131
    8 Roswell Park Comprehensive Cancer center Buffalo New York United States 14263
    9 UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina United States 27599
    10 Cleveland Clinic Cleveland Ohio United States 44195
    11 Oregon Health and Sciences University Portland Oregon United States 97239
    12 Thomas Jefferson University Hospital Philadelphia Pennsylvania United States 19107
    13 JPS Health Network Fort Worth Texas United States 76104
    14 Swedish Cancer Institute Seattle Washington United States 98104
    15 University of Washington Seattle Washington United States 98195
    16 University of Wisconsin Madison Wisconsin United States 53706

    Sponsors and Collaborators

    • University of Arizona
    • Pfizer

    Investigators

    • Principal Investigator: Pavani Chalasani, MD, The University of Arizona Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Arizona
    ClinicalTrials.gov Identifier:
    NCT03530696
    Other Study ID Numbers:
    • 29747
    • T-DM1
    • Palbo T-DM1
    First Posted:
    May 21, 2018
    Last Update Posted:
    Feb 16, 2022
    Last Verified:
    Feb 1, 2022
    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
    Keywords provided by University of Arizona
    Breast Cancer
    HER2-positive
    T-DM1
    HER2-positive Breast Cancer
    Recurrent Breast Cancer
    Metastatic Breast Cancer
    Additional relevant MeSH terms:
    Breast Neoplasms
    Palbociclib

    Study Results

    No Results Posted as of Feb 16, 2022