Clinical Trials /

T-DM1 and Palbociclib for Metastatic HER2 Breast Cancer

NCT03530696

Description:

This is a randomized phase II study to evaluate if the combination of T-DM1 with palbociclib improves progression-free survival compared to single agent T-DM1in patients with metastatic HER2 positive breast cancer

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: T-DM1 and Palbociclib for Metastatic HER2 Breast Cancer
  • Official Title: A Randomized Phase II Study to Evaluate Efficacy of T-DM1 With or Without Palbociclib in the Treatment of Patients With Metastatic HER2 Positive Breast Cancer

Clinical Trial IDs

  • ORG STUDY ID: 29747
  • SECONDARY ID: T-DM1
  • SECONDARY ID: Palbo T-DM1
  • NCT ID: NCT03530696

Conditions

  • HER2-positive Breast Cancer
  • Breast Cancer
  • Breast Cancer Stage
  • Recurrent Breast Cancer
  • Metastatic Breast Cancer
  • HER2 Positive Breast Carcinoma

Interventions

DrugSynonymsArms
PalbociclibIbranceT-DM1 with palbociclib
T-DM1KadcylaT-DM1 with palbociclib

Purpose

This is a randomized phase II study to evaluate if the combination of T-DM1 with palbociclib improves progression-free survival compared to single agent T-DM1in patients with metastatic HER2 positive breast cancer

Detailed Description

      This is a multi-center, randomized, phase II study of T-DM1 with or without palbociclib in
      the treatment of patients with metastatic HER2-positive breast cancer. Patients will be
      randomized 1:1 to T-DM1 with or without palbociclib.

      Hypotheses: Combination of T-DM1 with palbociclib improves progression free survival compared
      to single agent T-DM1

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

      Secondary objectives i) Compare response rates between both treatment arms ii) Compare
      overall survival between both treatment arms

      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
    

Trial Arms

NameTypeDescriptionInterventions
T-DM1 with palbociclibExperimentalT-DM1 is given IV every 21 days Palbociclib is administered days 5-18
  • Palbociclib
  • T-DM1
T-DM1Active ComparatorT-DM1 is given IV every 21 days
  • T-DM1

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Compare progression-free survival
Time Frame:4 years
Safety Issue:
Description:Compare progression-free survival of the combination arm (T-DM1 with palbociclib) to single agent T-DM1

Secondary Outcome Measures

Measure:Compare response rates
Time Frame:4 years
Safety Issue:
Description:Compare response rates between both treatment arms
Measure:Compare overall survival
Time Frame:4 years
Safety Issue:
Description:Compare overall survival between both treatment arms

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:University of Arizona

Trial Keywords

  • Breast Cancer
  • HER2-positive
  • T-DM1
  • HER2-positive Breast Cancer
  • Recurrent Breast Cancer
  • Metastatic Breast Cancer

Last Updated